Arena Pharmaceuticals (ARNA) announced positive Phase 2 results from the OASIS trial for etrasimod in ulcerative colitis (UC).
The Drug: Etrasimod is a selective sphingosine 1-phosphate (S1P) receptor modulator. Patients receiving the 2 mg dose of the drug achieved statistically significant improvements versus placebo in the primary, all secondary, and clinical remission endpoints.
Relative to placebo: there was a statistically significant improvement in a 3-component (stool frequency, rectal bleeding, and findings on endoscopy) Mayo Clinic Score (ranging from 0 to 9) with etrasimod 2 mg at week 12.
In the 1 mg group: there was a 0.43-point improvement in 3-component Mayo Clinic Score at week 12 relative to placebo, which was not statistically significant (p = 0.146).
In the 2 mg group: significantly more patients achieved endoscopic improvement compared with placebo.
The proportion of patients achieving clinical remission: 33.0% in the etrasimod 2 mg group compared to 8.1% for the placebo group (p < 0.001).
Remission as defined by the 4-component Total Mayo Clinic Score was 24.5% and 6.0% for etrasimod 2 mg and placebo, respectively (p = 0.004).
Etrasimod was well tolerated. Fewer patients had serious adverse events (SAEs) compared to placebo (0% in 2 mg, 5.8% in 1 mg and 11.1% in placebo).
Impact on heart rate and atrioventricular (AV) conduction: Low throughout the study with no discontinuations from bradycardia or AV block.
Liver: No increases in liver function tests compared to placebo.
Others: No reports of macular edema or pulmonary function test abnormalities.
The Company plans to present full study results at future medical congresses.
Observations and Comments
William Sandborn, M.D., Professor of Medicine and Chief, Division of Gastroenterology and Director, University of California San Diego Inflammatory Bowel Disease Center said, “The results of this Phase 2 trial are impressive and demonstrate statistically significant efficacy of orally administered etrasimod, including clinically meaningful improvement in remission, as well as endoscopic improvement in what has been historically referred to as mucosal healing.” Dr. Sandborn added, “Despite recent advances in treatment options, there remains a significant unmet need for new oral therapies for ulcerative colitis. I look forward to etrasimod advancing into a Phase 3 program.”
Preston Klassen, M.D., M.H.S., Executive Vice President, Research and Development and Chief Medical Officer of Arena Pharmaceuticals, said, “We believe these data support proceeding to a Phase 3 program in ulcerative colitis and continuing efforts to understand the broad potential utility of etrasimod in other immune and inflammatory diseases with significant unmet needs. Along with the positive Phase 2 results for ralinepag reported last year, this important milestone for the Company further amplifies our conviction in Arena’s internally discovered and developed compounds and their potential to be best-in-class.”
The results from the OASIS trial are definitely encouraging and we believe that we will see etrasimod soon in Phase 3 clinical trials. The stock rallied. We believe though that there is a possibility of profit taking and other market tactics that will take part of the gains at least for the near-term. Important is that the results on ulcerative colitis might have provided proof of concept regarding the ability of the product to bring positive results in the treatment of other autoimmune diseases, which would be great in case the optimistic speculations would materialize.
We consider the fact that the product is created in-house as a big positive in Arena’s classification regarding its scientific fundamentals. The results of the OASIS trial are, indeed, encouraging and we are looking forward to the outcome of the Phase 3 trials on ulcerative colitis and of its clinical trials with the firm’s wholly -owned pipeline products and its partnered pipeline products.
In premarket hours the stock is trading at $38.98 UP $8.09.
Before the rally the firm’s market cap. was around $1.2 billion.
We will be posting an article under Today’s Highlights tackling important news belonging to firms in the Prohost Portfolio and others that are not yet picked up by Prohost. Stay tuned.
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