Arena Pharmaceuticals, Inc. ARNA announced that it has dosed first patients in a phase II study to evaluate its key pipeline candidate — etrasimod — as a potential treatment for moderate-to-severe alopecia areata. The study will evaluate 2mg dose of the candidate for efficacy and safety over 24 weeks.
The primary endpoint of the phase II study is percent change in Severity of Alopecia Tool (“SALT”) score from baseline. Data from the study is anticipated in 2021.
The candidate has demonstrated potential to reduce inflammation and restore hair growth in earlier stage studies.
Shares of Arena have gained 50.5% year to date compared with the industry’s increase of 2.7%.
Alopecia areata is an autoimmune dermatologic condition that results in patchy non-scarring hair loss, usually affecting the scalp. There is no FDA approved drug presently available to treat this condition, which can lead to high levels of depression and anxiety in patients. Pfizer PFE is another company developing an oral JAK3 inhibitor candidate, PF-06651600 for Alopecia areata in a pivotal study.
Apart from alopecia areata, Arena is developing etrasimod in other indications as well. The candidate is presently in late-stage development for ulcerative colitis (“UC”). Arena is currently enrolling patients in two pivotal phase III studies — ELEVATE UC 52 and ELEVATE UC 12 — evaluating etrasimod for treating moderately-to-severely active UC.
A phase IIb study — ADVISE — is evaluating etrasimod in patients with atopic dermatitis (“AD”). Data from the study is expected later this year. Another phase IIb study — CULTIVATE — was initiated earlier this year to evaluate the candidate in Crohn's disease. The company has plans to start a mid-stage study to evaluate the candidate for eosinophilic esophagitis, a gastro-intestinal disease by year-end.
Arena has another key pipeline candidate, olonarib. The phase II CAPTIVATE study is evaluating olonarib as a treatment for abdominal pain associated with irritable bowel syndrome. Data from the study is expected later this year.
We note that Arena is progressing well with its key pipeline candidates. However, the company will face stiff competition from multiple approved drugs in their targeted indications. There are several drugs approved for treating UC including AbbVie’s ABBV multi-billion dollar drug, Humira. Sanofi/Regeneron’s REGN Dupixent is one of the top drugs approved for treating AD. Moreover, olonarib, following a potential approval, will compete with AbbVie/Ironwood Pharma’s Linzess.
Arena Pharmaceuticals, Inc. Price
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