Benzinga | Sep 30, 2021 05:59AM EDT

Eli Lilly and Company And Incyte Announce OLUMIANT Significantly Improved Hair Regrowth To At Least 80% Scalp Coverage As Early As 24 Weeks Across First Completed Phase 3 Studies For Alopecia Areata

Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today detailed results from two pivotal Phase 3 trials (BRAVE-AA1 and BRAVE-AA2), which found once-daily OLUMIANT(r) (baricitinib) 4-mg was superior to placebo in achieving significant scalp hair regrowth as early as 24 weeks in adults with severe alopecia areata (AA) as defined by ?50% scalp hair loss at baseline.

Significant improvements in scalp hair regrowth compared to placebo were achieved at 36 weeks for patients taking OLUMIANT 2-mg and 4-mg oral doses, as previously disclosed in topline findings from BRAVE-AA1 and BRAVE-AA2 earlier this year. In both studies, a greater proportion of patients taking OLUMIANT 4-mg compared to placebo also achieved full regrowth or regrowth with minimal gaps in coverage of eyebrow and eyelash hair at 36 weeks, which were key secondary endpoints of the studies.

These results, along with safety data in adult patients with moderate to severe atopic dermatitis (AD), are being presented virtually at the 30th European Academy of Dermatology and Venerology (EADV) Congress, taking place from Sept. 29-Oct. 2, 2021.

Alopecia areata is a widely misunderstood, autoimmune disease that can cause extreme and patchy hair loss on the scalp, face and other areas of the body, along with emotional distress and psychosocial effects. OLUMIANT has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of AA. Lilly plans to submit a supplemental New Drug Application (sNDA) to the FDA for OLUMIANT in AA in the second half of 2021.

OLUMIANT Demonstrated Improvement in Scalp, Eyelash and Eyebrow Hair Regrowth in Patients with AA in Two Phase 3 Trials

In BRAVE-AA1 and BRAVE-AA2, the first completed, randomized, double-blind, placebo-controlled Phase 3 trials for AA, 598 and 490 patients, respectively, underwent 36 weeks of treatment. Both studies included adults with severe AA, defined as a Severity of Alopecia Tool (SALT) score ?50 (those with ?50% scalp hair loss). At baseline, the participants had a mean SALT score of 85.5 (85.5% scalp hair loss, or 14.5% scalp hair coverage).

Across treatment groups, the average age of participants was 37.5 years old, and they had lived with AA for a mean of 12.2 years since first experiencing symptoms, with the onset for hair loss occurring at approximately age 25.

In BRAVE-AA1, statistically significant improvement in scalp hair regrowth occurred as early as 16 weeks among patients treated with OLUMIANT 4-mg and 24 weeks with OLUMIANT 2-mg, compared to placebo. At 16 weeks, nearly 1 in 5 patients (18.5%, n=52) taking OLUMIANT 4-mg achieved 80 percent or more scalp hair coverage (as measured by a SALT score ?20) as compared to placebo (4.2%, n=8, p?0.001). At 24 weeks, 1 in 10 patients (11.4%, n=21) taking OLUMIANT 2-mg achieved 80% or more scalp hair coverage as compared to placebo (4.8%, n=9, p=0.013).

In BRAVE-AA2, statistically significant improvement occurred as early as 24 weeks for patients treated with OLUMIANT 4-mg, with more than 1 in 4 patients (28.2%, n=66) reaching 80% or more scalp hair coverage as compared to placebo (1.3%, n=2, p?0.001).

Across both studies at 36 weeks -- the study's primary endpoint -- 1 out of 3 patients treated with OLUMIANT 4-mg (BRAVE-AA1=35.2% [n=99]; BRAVE-AA2=32.5% [n=76]) and approximately 1 out of 5 patients treated with OLUMIANT 2-mg (BRAVE-AA1=21.7% [n=40]; BRAVE-AA2=17.3% [n=27]) achieved 80% or more scalp hair coverage, compared to 5.3% of patients taking placebo (n=10) and 2.6% (n=4) in BRAVE-AA1 and BRAVE-AA2, respectively (p?0.001 for all comparisons to placebo).

Achievement of full regrowth or regrowth with minimal gaps in eyebrow and eyelash hair was also seen at 36 weeks with OLUMIANT 4-mg for 1 in 3 patients who at baseline had significant gaps or no notable eyebrows, as compared to patients taking placebo (BRAVE-AA1 eyebrow=31.4% [n=59]; BRAVE-AA1 eyelash=33.5% [n=56]; BRAVE-AA1 eyebrow placebo=3.2% [n=4]; BRAVE-AA1 eyelash placebo=3.1% [n=3]; BRAVE-AA2 eyebrow=34.8% [n=56]; BRAVE-AA2 eyelash=34.3% [n=48]; BRAVE-AA2 eyebrow placebo=4.5% [n=5]; BRAVE-AA2 eyelash placebo=5.6% [n=5]). This was measured by Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss(tm) and ClinRO Measure for Eyelash Hair Loss(tm) scores of patients achieving eyebrow and eyelash hair loss scores of 0 or 1 (full coverage or minimal gaps) with a ?2-point improvement from baseline at 36 weeks, respectively, compared to placebo (p?0.001 for all comparisons to placebo).

Statistically significant eyebrow regrowth results (19.1%, n=26, p?0.001) were also found for OLUMIANT 2-mg in BRAVE-AA1 at 36 weeks, but not in BRAVE-AA2. Eyelash results were not statistically significant with OLUMIANT 2-mg in either study.

The safety profile of OLUMIANT was consistent with previously-published safety data, and no new safety signals were observed in the 36-week duration of these clinical trials. Few patients discontinued treatment due to adverse events (2.6% or less across both studies and doses), and the majority of treatment-emergent adverse events were mild or moderate in severity. The most commonly reported adverse events (?5% in any treatment group in BRAVE-AA1 or BRAVE-AA2) included: upper respiratory tract infections, headache, acne, urinary tract infection and increases in blood markers related to the muscle.

For methodology, see the "About the Studies" section below.

"These findings are promising for patients with severe alopecia areata, as they support the potential for OLUMIANT to help patients regrow hair on the scalp, eyebrows and eyelashes," said Brett King, M.D., Ph.D., F.A.A.D., associate professor of dermatology at Yale University School of Medicine and lead author of these analyses. "Because there are no approved systemic therapies for alopecia areata, there is significant unmet need and health care providers and patients eagerly await approved treatment options for this disease."