Cosmo’s Rifamycin Gel Meets Phase 2 Remission Endpoint
Cosmo reported remission in 46.2% of patients versus 14.3% on placebo (p=0.0190). It plans FDA and EMA discussions and to advance toward Phase 3.
Cosmo N.V. said its topical rifamycin 1% gel met the primary endpoint in a Phase 2 study of mild-to-moderate distal ulcerative colitis and proctitis. Remission was achieved by 46.2% of patients, compared with 14.3% on placebo (p=0.0190). The company plans to discuss the results with the FDA and EMA and advance the program toward Phase 3.