Cumberland’s sclerosis study supports safety but cannot establish efficacy

Cumberland Pharmaceuticals ($CPIX) reported results from its 12-month ASSIST-SSc pilot study of oral ifetroban in systemic sclerosis. Thirty-one participants received the drug and ten received placebo. The company described tolerability as broadly consistent with earlier experience, with more gastrointestinal events and a modest increase in bleeding-related events on treatment; these were predominantly mild. No serious event during treatment was judged related to the study drug.

The Phase 2a trial was designed around safety and was too small to establish effectiveness. Limited disease progression in both groups also reduced the ability to detect a treatment difference. Cumberland plans further biomarker and cardiac-imaging analysis before deciding how to develop ifetroban in this indication. The readout informs that investment decision, but it does not demonstrate a clinical efficacy benefit or constitute regulatory approval.

Sources:

• PR Newswire