Cumberland Pharma's Ifetroban Meets Safety Goals in Phase 2a SSc Trial; Shares Fall 17.6% After Hours

Cumberland Pharmaceuticals Inc. (CPIX) said its Phase 2a ASSIST-SSc trial of oral ifetroban in systemic sclerosis supported the drug's safety and tolerability, though the study was not designed to assess efficacy. The stock fell $1.49, or 17.55%, in after-hours trading after closing Friday's regular session at $8.49, up $0.01. The 12-month trial enrolled 31 patients on ifetroban and 10 on placebo, covering diffuse cutaneous systemic sclerosis and SSc-associated pulmonary arterial hypertension. Gastrointestinal adverse events were more common with ifetroban but mostly mild and resolved; a modest increase in bleeding-related events was consistent with its thromboxane receptor antagonist mechanism. No serious adverse events during treatment were deemed drug-related. Cumberland said most patients in both arms had limited disease progression, reducing the ability to detect treatment differences. It plans to submit the clinical study report to the U.S. Food and Drug Administration and complete biomarker and cardiac imaging analyses from the open-label extension to guide future development.