Cosmo Pharmaceuticals (COPN) Study update summary

Unmet need and product rationale

• Distal disease affects an estimated 3.5M people worldwide, including ~2.54M in the U.S. and Europe; urgency and rectal symptoms burden patients, while topical options can have retention and adherence limitations.

• Rifamycin TAG is a locally delivered antibiotic with anti-inflammatory properties and a proposed multi-target mechanism; its non-immunosuppressive formulation and IP extend beyond 2044.

• The 1% formulation is liquid at room temperature and gels at body temperature; its adhesive properties support mucosal contact, while neutral pH is intended to improve tolerability.

Study design

• Double-blind, placebo-controlled Phase 2 randomized patients 2:1 to once-daily rifamycin 1% gel (800 mg/day) or placebo for six weeks; 76 patients had mild-to-moderate distal UC or ulcerative proctitis.

• Primary analysis included 60 completers; Week 6 remission required total Mayo score ≤2, stool frequency ≤1, no rectal bleeding and endoscopic score ≤1 without friability.

Efficacy results

• The primary endpoint was met: Week 6 remission was 46.2% with rifamycin gel vs 14.3% with placebo (p=0.0190), a 3.2-fold increase.

• Among patients with moderate baseline disease activity, remission was 48.3% vs 11.1%; the subgroup analysis reported p=0.0145.

• Secondary and exploratory endpoint analyses are ongoing, with full results planned for upcoming medical meetings or congresses.