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Enrollment complete for phase 2 trial of UC treatment candidate

Altheus Therapeutics has finalized enrollment of about 120 patients with distal ulcerative colitis for its ZA201 phase 2 trial, the company announced in a news release.

The 6-week, double blind, active-controlled clinical trial is intended to evaluate the safety and efficacy of the company’s Zoenasa rectal gel in comparison with mesalamine enema therapy, the current standard of care, the release said.

Patients will be randomly assigned to Zoenasa, a novel, patented combination of 4g mesalamine with 1g N-acetylcysteine, or 4g mesalamine.

“Positive ZA201 results will validate the entire Zoenasa platform, so we are pleased to have achieved this milestone,” Dennis Schafer, president and CEO of Altheus, said in the release. “We look forward to gaining alignment on our registration program with the FDA and other health authorities as the next step to making Zoenasa available to [inflammatory bowel disease] patients.”

Zoenasa has received orphan drug status by the FDA as treatment for pediatric ulcerative colitis, the release said. An oral formulation is in preclinical development.