Lilly and Incyte Announce Baricitinib Meets Primary Endpoint in Phase 3 Trial for Severe Alopecia Areata, Demonstrating Significant Hair Regrowth

Today, Eli Lilly and Company and Incyte jointly announced that the oral JAK inhibitor baricitinib met its primary endpoint in a Phase 3 clinical trial for the treatment of adults with severe alopecia areata. After 36 weeks of treatment, baricitinib significantly improved hair regrowth compared with placebo. The press release noted that baricitinib is the first JAK inhibitor to promote hair regrowth in a Phase 3 clinical trial for alopecia areata.

Alopecia areata is the second most prevalent form of hair loss globally, affecting approximately 147 million people worldwide, including about 4 million in China. It is an autoimmune disorder in which the immune system attacks hair follicles, resulting in partial or complete hair loss on the scalp, face, or other areas of the body. Symptoms often first appear during childhood, and individuals of any age, sex, or ethnicity can be affected. Currently, there are no FDA-approved therapies for this condition.

Baricitinib is an oral JAK inhibitor. The JAK family comprises a group of cytoplasmic tyrosine kinases, including four isoforms: JAK1, JAK2, JAK3, and TYK2. These kinases play a crucial role in mediating signal transduction for multiple cytokine receptors. JAK-mediated signaling pathways are involved in processes such as cell proliferation, differentiation, apoptosis, and inflammation. Baricitinib has been approved in more than 70 countries worldwide for the treatment of moderate to severe active rheumatoid arthritis under the brand name Olumiant. It has also received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of alopecia areata.

In the BRAVE-AA2 randomized, double-blind, placebo-controlled Phase 3 clinical trial, 546 patients with severe alopecia areata (hair loss affecting more than 50% of the scalp) received treatment with baricitinib or placebo. Notably, this trial included a diverse patient population from multiple countries worldwide, including China, South Korea, Japan, Brazil, Australia, Argentina, and the United States.

Trial results demonstrated that two different doses of baricitinib met the primary endpoint at 36 weeks, with a safety profile consistent with that observed in patients treated for rheumatoid arthritis and atopic dermatitis. Detailed results will be presented at upcoming medical conferences and published in a peer-reviewed journal later this year.

“For patients with alopecia areata, this is not merely a condition affecting appearance, but a serious autoimmune disease that can have significant psychological impacts. They lose far more than just their hair,” said Dr. Lotus Mallbris, Vice President of Immunology Development at Eli Lilly. “We look forward to sharing the complete data from the clinical development program for baricitinib, which has the potential to become the first approved therapy for alopecia areata.” Baricitinib is currently being evaluated in another Phase 3 clinical trial in patients with alopecia areata, with results expected to be announced in the first half of this year.

JAK inhibitors are the therapeutic approach most likely to achieve the first breakthrough in the treatment of alopecia areata. Currently, in addition to baricitinib, developed collaboratively by Eli Lilly and Incyte, multiple JAK inhibitors are undergoing clinical trials for the treatment of alopecia areata. Among them, ritlecitinib, developed by Pfizer, is a JAK3/TEC inhibitor that blocks the signaling pathways of IL-15 and CD8+ T cells, both of which are key drivers of immune-mediated destruction of hair follicle cells. Ritlecitinib has demonstrated promising efficacy in Phase 2 clinical trials in patients with alopecia areata and has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). Key results from its pivotal Phase 3 clinical trial are expected in the third quarter of this year. This innovative therapy was also proposed for inclusion in China’s Breakthrough Therapy Drug list last December, and four clinical studies are currently underway in China.

Furthermore, Concert Pharmaceuticals’ CTP-543 is an oral JAK1/2 inhibitor. It is a deuterated form of ruxolitinib; by replacing hydrogen atoms in the compound with deuterium atoms, it enhances the drug’s therapeutic properties, such as prolonging its half-life in vivo, improving oral bioavailability, and optimizing its safety profile. CTP-543 has also received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA), met its primary efficacy endpoints in Phase 2 clinical trials, and is currently being evaluated in Phase 3 clinical trials.

In China, Jacktinib, a JAK small-molecule inhibitor independently developed by Zeltigen Biopharmaceuticals, has also entered clinical trials as a topical cream for the treatment of mild-to-moderate alopecia areata. SHR0302, a selective JAK1 inhibitor developed by Hengrui Medicine, is currently in Phase II clinical trials for the treatment of alopecia areata.

Note: This article is intended to introduce medical and health research and does not constitute a recommendation for treatment plans. For guidance on treatment options, please consult a licensed healthcare provider at a reputable hospital.

References:

[1] Baricitinib is First JAK-Inhibitor to Demonstrate Hair Regrowth in Phase 3 Alopecia Areata (AA) Trial. Retrieved March 3, 2021, from https://www.prnewswire.com/news-releases/baricitinib-is-first-jak-inhibitor-to-demonstrate-hair-regrowth-in-phase-3-alopecia-areata-aa-trial-301239291.html

▽Follow [WuXi AppTecDe】WeChat Official Account