If Morphic Therapeutic's ulcerative colitis drug is approved by the FDA it would likely compete with Entyvio. Pfizer's etrasimod may also enter the fray.
Morphic Therapeutics announced positive top line results for the phase 2a EMERALD-1 study of MORF-057 for the potential treatment of moderate-to-severe ulcerative colitis in adults.
MORF-057 is an orally administered integrin receptor antagonist similar to Takeda Pharmaceuticals’ Entyvio (vedolizumab).
The FDA has approved Entyvio as a treatemnt for moderate-to-severe ulcerative colitis and Crohn’s disease in adults, and it is given as an intravenous (IV) infusion. A subcutaneous version of the drug is in the works.
The open-label EMERALD-1 study enrolled 35 patients with ulcerative colitis, each receiving MORF-057 100 mg twice daily. At 12 weeks, the study met its primary objective, demonstrating a significant reduction of 6.4 points in the Robarts Histopathology Index (RHI) score. The RHI measures histologic disease activity in ulcerative colitis. Additionally, the results show that the study participants experienced a 25.7% clinical remission rate based on the Modified Mayo Clinic Score (mMCS), and adverse events were generally mild.
Based on these encouraging results, the company, which is headquartered in suburban Boston, plans to continue enrollment in the phase 2b EMERALD-2 study. EMERALD-2 is an ongoing randomized, double-blind, placebo-controlled trial enrolling adults with moderate-to-severe ulcerative colitis. Participants will be randomized to receive MORF-057 100 mg twice daily, 200 mg twice daily, a once-daily dose of the study drug, or placebo. The primary endpoint is the clinical remission rate based on the mMCS at 12 weeks. Primary results are expected in May 2025.
Morphic seeks to develop a safe and effective oral treatment for ulcerative colitis. Bruce Sands, M.D., M.S., chief of gastroenterology division at the Mount Sinai Health System, said in a press release, “There are three desired attributes in an [inflammatory bowel disease (IBD)] treatment: favorable safety profile, meaningful clinical efficacy, and oral route of administration. Currently approved IBD treatments achieve at most two of these qualities and force patients to compromise; we need a new option to treat IBD patients that combines a high rate of clinical remission with a favorable safety profile in oral formulation.”
If approved, MORF-057 would likely compete with Entyvio.
It may also need to compete with Pfizer’s etrasimod, an oral selective sphingosine-1-phosphate (S1P) receptor modulator developed for the treatment of moderate-to-severe ulcerative colitis. The FDA is scheduled to make an approval decision about estrasimod sometime during the second half of this year.