Arena Initiates Dosing in Pivotal Colitis Study on Etrasimod

Arena Pharmaceuticals, Inc. ARNA announced that it has dosed the first patient in the pivotal phase III study — ELEVATE UC 52 — study evaluating its key pipeline candidate, etrasimod,  for moderately-to-severely active ulcerative colitis (“UC”). The study is part of the ELEVATE UC registrational program, which comprises two pivotal studies to evaluate etrasimod in UC patients.

Shares of Arena have rallied 46.9% this year so far, outperforming the industry’s increase of 1.4%.

The ELEVATE UC 52 study will evaluate etrasimod in the aforementioned patient population over 12 and 52 weeks for the primary endpoint of clinical remission as measured by improvement in Mayo score from baseline. The primary endpoint of the ELEVATE UC 52 study is similar to the successfully completed phase II OASIS study.

In January 2019, the company had announced positive data from its open label extension (“OLE”) of the OASIS study, which evaluated etrasimod in UC patients. Data from the study demonstrated sustained clinical response and clinical remission in patients after 46 weeks of treatment. While 79% of patients treated in the OLE study achieved clinical response, 39% achieved clinical remission. Clinical response and clinical remission were achieved in 82% and 50% of patients, respectively, in the sub-group in OLE study, which received 2mg of etrasimod in the original OASIS study. The positive results from OASIS study suggest strong potential of etrasimod in the pivotal study.

Arena is also developing etrasimod in other indications apart from UC. Two mid-stage studies are evaluating the candidate in Crohn's disease and atopic dermatitis.

The company has another candidate in its pipeline, olorinab, which is being evaluated as a treatment for pain associated with Crohn's disease and gastrointestinal pain.

We remind investors that Arena completed out-licensing of rights of its lead pipeline candidate — ralinepag — to United Therapeutics UTHR earlier this year. The candidate is in late-stage development for pulmonary arterial hypertension. The company received $800 million in upfront payment. It is also eligible to receive up to $400 million in potential milestone payment and tiered low double-digit royalties on net sales of ralinepag from United Therapeutics. The additional funds are likely to help the company support the clinical development of etrasimod and olorinab.

Arena Pharmaceuticals, Inc. Price

Arena Pharmaceuticals, Inc. price | Arena Pharmaceuticals, Inc. Quote

Zacks Rank & Stocks to Consider

Arena currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech sector include Anika Therapeutics Inc. ANIK and Acorda Therapeutics, Inc. ACOR, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Anika’s earnings per share estimates have increased from $1.21 to $1.31 for 2019 and from $1.21 to $1.33 for 2020 over the past 60 days. The stock has rallied 20.6% so far this year.

Acorda’s loss estimates narrowed from $3.84 to $3.59 for 2019 and from $3.32 to $3.09 for 2020 over the past 60 days.