Scientists are exploring the role of tau tangles in Alzheimer’s, and whether addressing these misfolded proteins could treat the disease. Here’s what you need to know.
Great Lakes Clinical Trials is recruiting individuals for the GREEN MEMORY trial. The trial is studying Oligomannate, a drug made from seaweed that has been successfully used for the treatment of Alzheimer’s Disease in China since 2019.
Great Lake’s Empathy Study conducted at their Gurnee site met endpoint goals of the study with an emphasis on an overall 78% reduction of hospitalization and/or ER visits related to COVID-19, or death across ensovibep arms compared to placebo.
Great Lakes Clinical Trials announced that their first participant has been dosed in the Phase 2 randomized, double-blind study of single dose psilocybin vs placebo. The purpose of this research is to study the medical and safety effects of a single dose of psilocybin compared to a placebo in participants with MDD.
Have you or someone you know started showing signs of COVID-19 within the past 7 days? Join our EMPATHY Study. Now enrolling at our Gurnee location.
The EMPATHY Study is looking at a research medication to help adults who have symptoms of COVID-19. The study will also look at whether the research medication reduces the risk of needing hospital or emergency care for COVID-19.
Great Lakes Clinical Trials' own Steve Satek was quoted today in the Chicago Defender article about the Global Alzheimer’s Platform Foundation’s breakthrough Biohermes Study.
Local Researchers Help Black & Brown Communities Detect Factors for Alzheimer’s Chicago’s Great Lakes Clinical Trials is now enrolling volunteers with and without memory concerns in the Global Alzheimer’s Platform Foundation’s Bio-Hermes Study. The study seeks to evaluate how blood or digital biomarker tests could best help predict the presence of amyloid plaques in the brain, a hallmark of Alzheimer’s disease.
The Global Alzheimer’s Platform Foundation’s focus is to make Alzheimer’s testing and resources accessible and accurate for every population, inclusive of the African-American community. Black people are 2-3 times more likely to receive an Alzheimer’s diagnosis, but this population is severely underrepresented in clinical research. Thus, the Bio-Hermes Study has committed to enrolling at least 20% Black and LatinX volunteers, nearly 4 times the national average in Alzheimer’s research. “We are committed to diversity in our recruitment because the science demands we consider the effectiveness of biomarker tests on various populations. We know that Alzheimer’s kills slowly and impacts every racial group but takes a particular toll on African Americans,” said John Dwyer, President of the Global Alzheimer’s Platform Foundation.
Read the full article here or click the button below.
CBS 2 Evening News highlighted Great Lakes Clinical Trials as being one of the research sites in Chicago conducting Johnson & Johnson’s two dose COVID-19 vaccine trial. J&J’s two dose study is evaluating the efficacy of the vaccine after both the first and second dose to asses protection against the virus and any potential benefits that may come with the added protection from a second dose.
Enrollment closed on March 31st, but the study has been continuing on with the other assessment visits scheduled throughout the duration of the two year study.
November 15, 2020 -- The Phase 3 ENSEMBLE study of the single-dose regimen of JNJ-78436735, the investigational vaccine candidate for the prevention of COVID-19 being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, continues to enroll and vaccinate study participants. ENSEMBLE is proceeding to enroll up to 60,000 participants worldwide.
In addition to the single-dose regimen ENSEMBLE study, Janssen has now initiated the two-dose regimen ENSEMBLE 2 trial. ENSEMBLE 2 is a complementary, planned, pivotal, large-scale, multi-country Phase 3 trial that will study the safety and efficacy of a two-dose regimen of the investigational Janssen vaccine candidate for the prevention of COVID-19 in up to 30,000 participants worldwide. The ENSEMBLE and ENSEMBLE 2 trials will run in parallel.
While a potentially safe and effective single-dose preventive COVID-19 vaccine would have significant benefits, particularly in a pandemic setting, Janssen’s COVID-19 vaccine program has been designed to be extremely thorough and driven by science. As such, we are investigating multiple doses and dosing regimens to evaluate their long-term efficacy.
The Phase 3 ENSEMBLE and ENSEMBLE 2 trials follow positive interim results from the Company’s ongoing Phase 1/2a clinical study, which is studying the safety profile and immunogenicity of both a single-dose and two-dose vaccination. The interim analysis showed that a single dose of the COVID-19 vaccine candidate induced a robust immune response and was generally well-tolerated.
PHASE 3 ENSEMBLE 2 STUDY
The Phase 3 ENSEMBLE 2 study (NCT04614948) is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a two-dose vaccine regimen versus placebo in adults 18 years old and older with and without comorbidities associated with an increased risk for severe COVID-19. The study will assess efficacy of the investigational vaccine after both the first and second dose to evaluate protection against the virus and potential incremental benefits for duration of protection with a second dose.
Janssen will aim to enroll participants in Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, the United Kingdom and the United States. In order to evaluate the efficacy of Janssen’s COVID-19 vaccine candidate, clinical trial sites in countries and areas with high incidence of COVID-19 and the ability to achieve a rapid initiation were selected.
ENSEMBLE 2 is being conducted in collaboration with the UK National Institute for Health Research (NIHR).
The Company is committed to transparency and sharing information related to the Phase 3 ENSEMBLE 2 study.
JANSSEN’S INVESTIGATIONAL COVID-19 VACCINE CANDIDATE
The Janssen COVID-19 vaccine candidate leverages the Company’s AdVac® technology platform, which was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine and construct its Zika, RSV, and HIV investigational vaccine candidates. Janssen’s AdVac® technology platform has been used to vaccinate more than 110,000 people to date across Janssen’s investigational vaccine programs.
For more information on Johnson & Johnson’s multi-pronged approach to helping combat the pandemic, visit: www.jnj.com/coronavirus.
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Notice to Investors Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of potential preventive and treatment regimens for COVID-19. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
Three members of the Great Lakes Clinical Trials team are featured in this week’s #AlwaysAndersonville podcast to talk about their new Keep Andersonville COVID Safe initiative in partnership with the Andersonville Chamber of Commerce and the important COVID-19 clinical trials that are taking place right here in the neighborhood.
““The same studies that you are reading about in popular press and the New York Times about monoclonal antibodies, these are the studies that Great Lakes are bringing to patients.””
This week, Joelle & David are joined by Steve Satek, President and Founder of Great Lakes Clinical Trials, Amber Holst, Director of Operations, and Dr. Manish Jain, one of the Principal Investigators at Great Lakes. Dr. Jain has been leading COVID-19 trials at Great Lakes, and is a board-certified Rheumatologist. All three have returned to the podcast to talk about the new Keep Andersonville COVID-Safe initiative in partnership with the Andersonville Chamber of Commerce.
Great Lakes Clinical Trials is proud to share clinical trial results from a study conducted by our COVID research specialists in conjunction with our hospital partners including Swedish Hospital, Weiss Memorial Hospital and West Suburban Medical Center.
This clinical trial (called “EMPACTA”), was sponsored by Roche/Genentech and showed that Actemra/RoActemra reduced the likelihood of needing mechanical ventilation in hospitalized patients with COVID-19 associated pneumonia.
“Importantly this was first global phase III COVID trial with a focus on enrolling largely underserved and minority patients,” commented Steve Satek, President of Great Lakes Clinical Trials. Approximately 85% of the 389 patients were from minority racial and ethnic groups. The majority of patients were Hispanic, with significant representation of Native American and Black populations.
We are proud to work so closely with our hospital partners on our COVID studies, and provide access to global clinical trials within the north side communities of Chicago. Besides Great Lakes Clinical Trials, this study was conducted at 69 research center throughout the United States, South Africa, Kenya, Brazil, Mexico and Peru.
To view the current COVID-related research studies being conducted at Great Lakes Clinical Trials, including our upcoming vaccine programs, please click HERE.
To view the original press release from Roche/Genentech , click on the button below.
Great Lakes Clinical Trials will soon be enrolling volunteers, ages 18 and up, into multiple COVID Vaccine Clinical Trials at our Andersonville clinic.
In many cases these are the same trials being conducted at University of Chicago, Yale University, Johns Hopkins and UCLA. Great Lakes Clinical Trials brings access to the same, world class research to our local community on the north side of Chicago.
These trials will enroll VERY quickly as there is very high demand.
If you are interested in joining these ground-breaking clinical trials, or simply want to learn more about these programs, please complete our brief survey by clicking the button below. When these studies open for enrollment, respondents will be contacted in the order of their survey completion. At that time, we will provide greater details about each particular study.
Steve Satek, President of Great Lakes Clinical Trials
Great Lakes Clinical Trials is proud to share clinical trial results from a study currently underway at our outpatient research center in Andersonville. “This class of medications holds much promise for treating COVID-19 infection, reducing viral load and shortening the duration of COVID symptoms,” commented Steve Satek, President of Great Lakes Clinical Trials. “Though these are only interim results, but they are encouraging. I’d like to personally thank the study participants who have contributed to this program.”
This clinical trial is still accepting participants at Great Lakes Clinical Trials. If you are experiencing COVID-like symptoms, such as fever, shortness of breath, headache, diarrhea or fatigue, please contact our center to see if this study is right for you. The Great Lakes Clinical Trials team is offering free 15-minute rapid testing for COVID-19 to see if you qualify - or you can come to our clinic with your own test results if they were obtained within 3 days.
“This concept of treating patients immediately after receiving a diagnosis is important, “ added Satek. “As it currently stands, most people who receive a diagnosis are sent home to quarantine and wait it out - not knowing if the disease symptoms will progress or not. Though we do not yet know definitely if this investigational medication will work and be approved by the FDA, we are very supportive of researching a treatment option to immediately reduce viral load and limit symptom duration.”
To view the original press release from Eli Lilly , click on the button below. Otherwise, you can view the announcement of study results below from The American Academy for the Advancement of Science (AAAS)
By Meredith Wadman Sep. 16, 2020 , 11:15 AM
https://www.sciencemag.org/news/2020/09/eli-lilly-reports-first-promising-results-antibody-against-covid-19
Today brings the first whisper of success for a class of closely watched drugs that it’s hoped will begin to beat back COVID-19 before vaccines are licensed: monoclonal antibodies, engineered versions of the same virus-fighting antibodies that the body naturally produces.
Eli Lilly reports this morning interim results from a placebo-controlled trial of one such compound, cloned in quantity from an antibody captured from the blood of a patient who recovered from COVID-19. In June, the company began a trial delivering either placebo or one of three doses of the antibody, called LY-CoV555, to 452 patients. These were not gravely ill people, but patients with mild or moderate symptoms who had tested positive for SARS-CoV-2 within the past 3 days and had not been hospitalized.
Five of 302 patients who received the drug ended up being hospitalized—1.7%. But nine of the 150 placebo patients ended up in the hospital—6%—meaning there was a 72% reduced risk of being hospitalized for patients who received the antibody versus those who received a placebo. The drug produced no serious side effects, the company reports.
“Since these are the first clinical data we’ve seen from neutralizing antibodies, I find the results quite encouraging, for lack of safety issues and supportive signs—not definitive, by any means—of having efficacy,” says Eric Topol, a cardiologist who directs the Scripps Research Translational Institute. “So much is riding on this class of drugs for prevention, early treatment (as in this trial),” and use in hospitals before patients become critically ill.
Most of those hospitalized were older or had a higher-than-healthy body mass index, a gauge of obesity, “suggesting a more pronounced treatment effect for patients in these higher-risk groups,” according to Lilly’s press release. Daniel Skovronsky, the company’s chief scientific officer, told The Wall Street Journal these risk factors could guide who receives the antibody if supplies are limited, assuming that the antibody is approved by the U.S. Food and Drug Administration (FDA).
But only the middle dose of the antibody reached the trial’s primary goal: a significant reduction of the load of coronavirus in the blood of patients after 11 days. Lower and higher doses did not meet this mark. The biological effect of a drug is normally expected to increase with the dose, so the finding that the higher dose did not reach the endpoint boosts the possibility that the middle dose’s impact was due to chance.
What’s more, the company declined to say whether the difference in hospitalization rates for treated patients as compared with those who received placebo reached statistical significance, and several analysts raised their eyebrows about whether the effect is meaningful, as Endpoints News reports.
Still, Skovronsky told STAT the company hopes to discuss a possible emergency use authorization with FDA, which requires less, and less definitive, efficacy data from a company than what’s required for an unqualified FDA approval to move a drug to market.
The Lilly trial is ongoing, aiming to enroll a total of 800 patients, and includes another Lilly antibody, LY-CoV016, which binds to a different target on the virus’ spike protein. Regeneron Pharmaceuticals also has a pair of coronavirus-targeting antibodies in clinical trials in hospitalized and nonhospitalized patients, with preliminary results expected later this month.
“The monoclonal antibody class represents our best shot for a near term, potent intervention even though they are difficult to produce at scale and will likely carry a high cost,” Topol says.
Great Lakes Clinical Trials is proud to share successful randomized, controlled clinical trial results announced today from Eli Lilly on the use of Baricitinib in hospitalized patients with COVID (ACTT-2 Study).
“Though we did not participate in the ACTT-2 trial, our team is conducting a sister study with this same medication (COV-BARRIER Study) in conjunction with our local partner, Swedish Covenant Hospital,” commented Steve Satek, President of Great Lakes Clinical Trials. “Our team is proud to be on the front lines in finding a cure for this disease, and these newly reported results are encouraging.”
The COV-BARRIER Study is part of a portfolio of COVID-related clinical trials being conducted by Great Lakes Clinical Trials, which include vaccine studies, validation of COVID testing systems, studies for outpatients and hospitalization trials. Our clinic does offer free rapid testing for individuals who may be experiencing COVID-like symptoms. For more information on our COVID clinical trials click here.
The full press release for these reported trial results in provided below, or you can click here to view the original content.
Published: Sep 14, 2020
Study Met Primary Endpoint of Reduction of Time to Recovery
Additional Analyses Ongoing to Understand Other Clinical Outcome Data
Lilly's Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Baricitinib Continues
INDIANAPOLIS, Sept. 14, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today initial data emerging from the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). ACTT-2 included more than 1,000 patients and began on May 8 to assess the efficacy and safety of a 4-mg dose of baricitinib plus remdesivir versus remdesivir in hospitalized patients with COVID-19. Baricitinib in combination with remdesivir met the primary endpoint of reduction of time to recovery in comparison with remdesivir.
Study investigators noted an approximately one-day reduction in median recovery time for the overall patient population treated with baricitinib in combination with remdesivir versus those treated with remdesivir. This finding was statistically significant. Recovery was defined as the participant being well enough for hospital discharge, meaning the participant either no longer required supplemental oxygen or ongoing medical care in the hospital, or was no longer hospitalized at Day 29. The study also met a key secondary endpoint comparing patient outcomes at Day 15 using an ordinal 8-point scale ranging from fully recovered to death.
An independent data and safety monitoring board overseeing the double-blind, randomized controlled trial met regularly throughout the trial to review safety data. Additional analyses are ongoing to understand other clinical outcome data, including mortality and safety data. NIAID is expected to publish full details of the study in a peer-reviewed journal.
"We are pleased with these data from the ACTT-2 study," said Patrik Jonsson, Lilly senior vice president and president of Lilly Bio-Medicines. "There is an urgent need to identify COVID-19 treatments, and we will continue to work with NIAID to understand these data and next steps on baricitinib's role moving forward. We appreciate NIAID selecting baricitinib for inclusion in this important study and the participants, investigators and collaborators for the vital roles they played."
"These findings from ACTT-2 are another step as we improve the care of these patients," said Andre Kalil, M.D., professor at the University of Nebraska Medical Center and a principal investigator of the ACTT studies. "These data may help us to better understand baricitinib's potential role in the treatment of COVID-19."
Based on the ACTT-2 data, Lilly plans to discuss the potential for emergency use authorization (EUA) with the U.S. Food and Drug Administration (FDA) and to explore similar measures with other regulatory agencies for baricitinib as a treatment of hospitalized patients with COVID-19. If authorized for use, Lilly will propose that baricitinib be available through commercial channels and will work with hospitals and governments to ensure patient access. Lilly will continue to create adequate supply for rheumatoid arthritis (RA) patients and ensure baricitinib remains available in countries where it is approved. In the U.S., baricitinib is approved for RA patients at a 2-mg daily dose; an EUA would potentially authorize a 4-mg dose for COVID-19.
Lilly will review the ACTT-2 data with NIAID and assess any impact on COV-BARRIER, the Phase 3 randomized, double-blind, placebo-controlled study it initiated in June to evaluate the efficacy and safety of baricitinib versus background therapy in hospitalized adults with COVID-19 in the U.S., Europe, Asia and Latin America.
"As a company, we've moved quickly to develop and evaluate medicines for patients for the prevention and treatment of COVID-19," said Daniel Skovronsky, M.D., Ph.D., Lilly senior vice president and chief scientific officer. "These data allow us to better understand baricitinib's role in potentially improving outcomes for hospitalized COVID-19 patients, and we look forward to continuing this research alongside our other initiatives to combat COVID-19."
Baricitinib, a JAK1/JAK2 inhibitor licensed to Lilly from Incyte and marketed as OLUMIANT®, is approved in more than 70 countries as a treatment for adults with moderately to severely active RA. Studying baricitinib in controlled trials is important in order to better characterize its potential benefits and understand the safety of its use as a COVID-19 treatment. The U.S. prescribing information for the approved use of baricitinib for RA includes boxed warnings regarding the use of baricitinib, including warnings about risk for developing blood clots and serious infections.
Lilly is also currently supporting ongoing multisite and single-site investigator-initiated trials in Europe and North America for hospitalized patients with COVID-19 infections.
About Lilly's COVID-19 Efforts
Lilly is bringing the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Existing Lilly medicines are now being studied to understand their potential in treating complications of COVID-19, and the company is collaborating with two partner companies to discover novel antibody treatments for COVID-19. Lilly intends to test both single antibody therapy as well as combinations of antibodies (sometimes known as antibody cocktails) as potential therapeutics for COVID-19. Click here for media resources related to Lilly's COVID-19 efforts.
Indication and Usage for OLUMIANT (baricitinib) tablets (in the United States) for RA patients
OLUMIANT® (baricitinib) 2-mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Limitation of Use: Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.
IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) TABLETS
WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS
SERIOUS INFECTIONS: Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:
Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.
Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
Bacterial, viral, and other infections due to opportunistic pathogens.
Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.
Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
MALIGNANCIES: Lymphoma and other malignancies have been observed in patients treated with Olumiant.
THROMBOSIS: Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. Patients with symptoms of thrombosis should be promptly evaluated.
WARNINGS AND PRECAUTIONS
SERIOUS INFECTIONS: The most common serious infections reported with Olumiant included pneumonia, herpes zoster and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than local disease and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients:
with chronic or recurrent infection
who have been exposed to TB
with a history of a serious or an opportunistic infection
who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or
with underlying conditions that may predispose them to infection.
Closely monitor patients for infections during and after Olumiant treatment. Interrupt Olumiant if a patient develops a serious infection, an opportunistic infection, or sepsis. Do not resume Olumiant until the infection is controlled.
Tuberculosis – Before initiating Olumiant evaluate and test patients for latent or active infection and treat patients with latent TB with standard antimycobacterial therapy. Olumiant should not be given to patients with active TB. Consider anti-TB therapy prior to initiating Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection. Monitor patients for TB during Olumiant treatment.
Viral Reactivation – Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves.
The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.
MALIGNANCY AND LYMPHOPROLIFERATIVE DISORDERS: Malignancies were observed in Olumiant clinical studies. Consider the risks and benefits of Olumiant prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing Olumiant in patients who develop a malignancy. NMSCs were reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
THROMBOSIS: Thrombosis, including DVT and PE, has been observed at an increased incidence in Olumiant-treated patients compared to placebo. In addition, arterial thrombosis events in the extremities have been reported in clinical studies with Olumiant. Many of these adverse events were serious and some resulted in death. There was no clear relationship between platelet count elevations and thrombotic events. Use Olumiant with caution in patients who may be at increased risk of thrombosis. If clinical features of DVT/PE or arterial thrombosis occur, evaluate patients promptly and treat appropriately.
GASTROINTESTINAL PERFORATIONS: Gastrointestinal perforations have been reported in Olumiant clinical studies, although the role of JAK inhibition in these events is not known. Use Olumiant with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.
LABORATORY ABNORMALITIES:
Neutropenia – Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000 cells/mm3) compared to placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.
Lymphopenia – Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.
Anemia – Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. Evaluate at baseline and thereafter according to routine patient management.
Liver Enzyme Elevations – Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of ALT ≥5x upper limit of normal (ULN) and increases of AST ≥10x ULN were observed in patients in Olumiant clinical trials.
Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.
Lipid Elevations – Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation. Manage patients according to clinical guidelines for the management of hyperlipidemia.
VACCINATIONS: Avoid use of live vaccines with Olumiant. Update immunizations in agreement with current immunization guidelines prior to initiating Olumiant therapy.
HYPERSENSITIVITY: Reactions such as angioedema, urticaria, and rash that may reflect drug sensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.
ADVERSE REACTIONS
Most common adverse reactions include: upper respiratory tract infections (16.3%, 11.7%), nausea (2.7%, 1.6%), herpes simplex (0.8%, 0.7%) and herpes zoster (1.0%, 0.4%) for Olumiant 2 mg and placebo, respectively.
USE IN SPECIFIC POPULATIONS
PREGNANCY AND LACTATION: No information is available to support the use of Olumiant in pregnancy or lactation. Advise women not to breastfeed during treatment with Olumiant.
HEPATIC AND RENAL IMPAIRMENT: Olumiant is not recommended in patients with severe hepatic impairment or in patients with severe renal impairment.
Please click to access full Prescribing Information, including Boxed Warning about Serious Infections, Malignancies, and Thrombosis, and Medication Guide.
BA HCP ISI 09JUL2020
About OLUMIANT®
OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitor therapies, and approved outside of the U.S. for patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs.i There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases.ii OLUMIANT has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3; however, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.i
In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.
About Eli Lilly and Company
Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom. P-LLY
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about OLUMIANT (baricitinib) as a potential treatment for patients with COVID-19 and as a treatment for patients with rheumatoid arthritis, and about the supply of OLUMIANT, and reflects Lilly's and Incyte's current beliefs. This press release also contains a forward-looking statement about Lilly's potential antibody treatments for COVID-19. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that OLUMIANT will receive additional regulatory approvals or continue to be commercially successful, that we can provide an adequate supply of OLUMIANT in all circumstances, or that potential antibody treatments will be safe and effective. For further discussion of these and other risks and uncertainties, see Lilly's and Incyte's most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.
i Olumiant Prescribing Information, 2020.
ii Walker JG and Smith MD. J Rheumatol. 2005;32;1650-1653.
Refer to:
Kristen Porter Basu; basu_kristen_porter@lilly.com; 317-447-2199 (media)
Kevin Hern; hern_kevin_r@lilly.com; 317-277-1838 (investors)
Catalina Loveman; cloveman@incyte.com; 302-498-6171 (Incyte media)
Michael Booth, DPhil; mbooth@incyte.com; 302-498-5914 (Incyte investors)
BLAZE-1 Study is evaluating a potential COVID-19 antibody treatment following successful laboratory studies.
Chicago; August 19 , 2020 – Great Lakes Clinical Trials announced today it has begun recruiting and treating patients in a clinical research study to evaluate the safety and effectiveness of LY-CoV555 in patients with early mild to moderate COVID-19. Sponsored by Eli Lilly and Company (Lilly), the BLAZE-1 Study is looking for adults ages 18 or older who have recently tested positive for COVID-19 and are not hospitalized.
LY-CoV555 is an antibody therapy engineered from one of the first individuals in the U.S. to recover from COVID-19 and is specifically designed to attack SARS-CoV-2, the virus that causes COVID-19.Laboratory studies have shown that LY-CoV555 binds with high affinity to the SARS-CoV-2 virus and neutralizes its ability to infect cells and replicate.
“Clinical trials like BLAZE-1 are vital in testing potential treatments for COVID-19 which, if successful, represent medicines which can be used to protect those most at risk of severe illness, such as the elderly and immunocompromised,” said Steve Satek, President & Founder, Great Lakes Clinical Trials. “Great Lakes Clinical Trials has been on the front lines of the fight against COVID-19, and we are honored to participate in this important, landmark study with Lilly to potentially bring effective COVID-19 treatment to the public faster.”
To be eligible for the BLAZE-1 Study, participants must have tested positive for SARS-CoV-2 infection within three days prior to the study drug infusion, and have one or more mild or moderate COVID-19 symptoms, including, fever, cough, sore throat, headache, muscle pain, nausea, abdominal pain, diarrhea, or shortness of breath when active.
If a person is eligible and decides to participate, the research staff at Great Lakes Clinical Trials will perform specific tests and procedures to monitor the patient’s health and how their body reacts to the LY-CoV555 antibody treatment. These tests and procedures include physical exams, vital sign measurements, blood samples, and nasopharyngeal swabs to measure levels of virus.
The study drug is being compared to a placebo, and both the study drug and the placebo will be administered as a single-dose intravenous (IV) infusion. Participants will be randomly selected to receive the placebo or the study drug.
“Kicking off the BLAZE-1 Study with research sites around the country, including Great Lakes Clinical Trials, is a huge milestone for the global fight against COVID-19, and we’re excited to bring the industry one step closer to a potential treatment,” said Dr. Daniel Skovronsky, chief scientific officer, Eli Lilly and Company. “We look forward to working with eligible patients who are not only interested in receiving investigational treatments for COVID-19, but who also understand how their participation can impact the health and well-being of millions of people around the world.”
If someone has tested positive and exhibited symptoms for COVID-19, and are interested in participating in clinical research in their area, call 833.277.0197 or visit JoinCOVIDStudy.com to learn more.
