Lilly and Incyte's Baricitinib Improved Hair Regrowth for Alopecia Areata Patients in Second Phase 3 Study

- Results from two studies (BRAVE-AA1 and BRAVE-AA2) show statistically significant improvement in scalp hair regrowth across both baricitinib dosing groups, compared to placebo

- Program data will support a submission to achieve a potential first-in-disease regulatory approval

- Safety profile is consistent with the known safety findings for baricitinib

INDIANAPOLIS, IN, USA I April 20, 2021 I Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today results from a second Phase 3 trial (BRAVE-AA1) evaluating the efficacy and safety of once-daily baricitinib 2-mg and 4-mg in adults with severe alopecia areata (AA). The data are consistent with findings from the first Phase 3 clinical trial, BRAVE-AA2, top-lined earlier this year. In both investigational trials, a statistically significant proportion of patients treated with baricitinib achieved the primary endpoint of hair regrowth across the two dosing regimens at Week 36 compared to patients treated with placebo. AA is an autoimmune disease that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress, and currently has no therapies approved by the U.S. Food and Drug Administration (FDA).

"There is a pressing need for approved treatment options for people suffering from alopecia areata as existing topicals and steroids do not provide meaningful improvement for many patients," said Maryanne Senna, M.D., dermatologist and assistant professor of dermatology at Harvard Medical School and clinical trial investigator of BRAVE-AA1. "I am pleased to see such positive results from these important trials of baricitinib offering a much-needed potential breakthrough treatment option for this disease." 

The BRAVE-AA trial program was designed to evaluate the efficacy and safety of baricitinib in adult patients with severe AA. The program consists of two trials: BRAVE-AA1 and BRAVE-AA2. BRAVE-AA1 is a multicenter, randomized, double-blind, placebo-controlled adaptive Phase 2/3 trial. Based on interim results of the Phase 2 portion of BRAVE-AA1 at Week 12, baricitinib 2-mg and 4-mg once-daily doses were selected for further evaluation in the Phase 3 portion of the study. BRAVE-AA2 is a multicenter, randomized, double-blind, placebo-controlled study evaluating the baricitinib 2-mg and 4-mg dosing regimens versus placebo. Both studies included adults with severe alopecia, defined in the BRAVE clinical trials as a Severity of Alopecia Tool (SALT) score ≥ 50 (i.e., who had ≥ 50% scalp hair loss), in addition to a current episode of AA lasting at least six months but no more than eight years.

BRAVE-AA1 and BRAVE-AA2 Study Results
In both studies, over the nine-month treatment period, patients with severe AA treated with baricitinib 2-mg and 4-mg doses experienced significantly greater scalp hair regrowth compared to patients treated with placebo based on physician's assessment.

Results of BRAVE-AA1 showed that at Week 36, the proportion of patients reaching 80 percent or more scalp hair coverage was achieved by 35 percent (p≤0.001) of patients treated with baricitinib 4-mg/day, 22 percent (p≤0.001) of patients treated with baricitinib 2-mg/day and five percent of patients in the placebo group, meeting the primary endpoint.

BRAVE-AA2 showed that at Week 36 the proportion of patients reaching 80 percent or more scalp hair coverage was achieved by 33 percent (p≤0.001) of patients treated with baricitinib 4-mg/day, 17 percent (p≤0.001) of patients treated with baricitinib 2-mg/day and three percent of patients in the placebo group, meeting the primary endpoint.   

Across both studies, the proportion of patients self-reporting at least 80 percent scalp hair coverage was significantly greater in the 2-mg and 4-mg groups compared to placebo (p≤0.001) by Week 36.

The most common treatment-emergent adverse events (TEAEs) in BRAVE-AA1 and BRAVE-AA2 included upper respiratory tract infections, headache and acne. No deaths or venous thromboembolic events (VTEs) were reported in the trials. The safety profile of baricitinib in the two studies was consistent with its known safety profile in patients with rheumatoid arthritis (RA) and atopic dermatitis (AD).

Lilly will present detailed data from these studies at scientific meetings later this year and submit the results to peer-reviewed journals. Based on these results, Lilly plans to submit a supplemental New Drug Application (sNDA) to the FDA for baricitinib in AA in the second half of 2021, followed by submissions to other regulatory agencies around the world. In Q1 2020, baricitinib received Breakthrough Therapy designation from the FDA for the treatment of AA.

"The positive results from our Phase 3 trials of baricitinib in alopecia areata bring us one step closer to potentially providing an approved treatment option to people affected by this serious autoimmune disease," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. "We look forward to discussing with global regulators data from the BRAVE-AA clinical trial program for this important potential treatment, which could be the first approved for people living with alopecia areata."

Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. Baricitinib is approved and commercially available as OLUMIANT in the U.S. and more than 70 countries as a treatment for adults with moderately to severely active RA and in Europe and Japan for the treatment of adult patients with moderate to severe AD who are candidates for systemic therapy. AA is the second potential treatment indication in dermatology for baricitinib.

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: Use of OLUMIANT in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

About OLUMIANT®

OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. and more than 70 countries as a treatment for adults with moderate to severe rheumatoid arthritis and was recently approved in the European Union and Japan for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. The U.S. FDA-approved labeling for Olumiant includes a Boxed Warning for Serious Infections, Malignancy, and Thrombosis. See the full Prescribing Information here.

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 Alopecia Areata

Alopecia areata (AA) is an autoimmune disease that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress. AA often first appears during childhood and can be different for everyone who has it. People of all ages, males/females and all ethnic groups can develop AA.

About Lilly in Dermatology

By following the science through unchartered territory, we continue Lilly's legacy of delivering innovative medicines that address unmet needs and have significant impacts on people's lives around the world. Skin-related diseases are more than skin deep. We understand the devastating impact this can have on people's lives. At Lilly, we are relentlessly pursuing a robust dermatology pipeline to provide innovative, patient-centered solutions so patients with skin-related diseases can aspire to live life without limitations.

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.

SOURCE: Eli Lilly

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