Dive Brief:
- Arena Pharmaceuticals, Inc.'s S1P modulator etrasimod hit all of its primary, secondary and clinical remission endpoints at its higher dose in the OASIS study of patients with ulcerative colitis.
- At week 12, there were significant improvements in stool frequency, rectal bleeding and endoscopy findings at the 2 mg dose compared with placebo, but not with the 1 mg dose. A third of patients in the higher dose group went into clinical remission, compared with just 8.1% in the placebo group.
- Arena is planning a Phase 3 clinical trial, and more detailed results of the Phase 2 study will be presented at a forthcoming medical meeting. The results were announced after the close of the market on Monday; Arana's shares were up 35%, or about $11, to trade above $41 per share.
Dive Insight:
Arena made its name a decade ago as a hot stock investors poured money into as the biotech brought its obesity treatment forward. But neither the drug, nor the obesity space, ever took off and Arena was left floundering. In January 2017, Arena made the move to sell off the drug and focus its attentions elsewhere. (Arena's competitors in the obesity space weren't quite so smart.)
Arena instead has turned its attention to etrasimod for ulcerative colitis. The drug is also being developed in pyoderma gangrenosum and primary billary cholangitis.
The company is also bringing forward a drug for pulmonary arterial hypertension (PAH). Ralinepag scored positive data in a Phase 2 trial last year, and plans for a Phase 3 trial are under way.
The results for these two drugs may validate Arena's step away from obesity.
"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," said Arena Chief Medical Officer Preston Klassen.