Cumberland Pharmaceuticals Announces Data From Its Phase 2 ASSIST-SSc Study Of Oral Ifetroban For Patients With Systemic Sclerosis; Gastrointestinal Adverse Events Were More Frequent In Ifetroban Group Than Placebo; Majority Of Patients Demonstrated Limited Disease Progression, Which Reduced Ability To Track Treatment Difference

Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), an innovation-driven biopharmaceutical company advancing new therapies that address significant unmet medical needs, announces top-line results from its Phase 2a ASSIST-SSc trial evaluating oral ifetroban for patients with systemic sclerosis ("SSc"). These results support the safety and tolerability of ifetroban in this rare disease population. Cumberland will next complete correlative biomarker studies using specimens collected during the trial, along with an evaluation of cardiac imaging from patients continuing on the open-label extension.

Ifetroban was generally well tolerated, with a safety profile consistent with prior experience. As in prior ifetroban studies, gastrointestinal adverse events were more frequent in the ifetroban group than in the placebo group; the majority were mild and resolved. A modest increase in bleeding-related adverse events was also observed with ifetroban, in keeping with its mechanism as a thromboxane prostanoid receptor antagonist, and these events were predominantly mild. No serious adverse event during the 12-month treatment period was assessed by the medical monitor as related to study drug.

The majority of subjects in both treatment groups showed limited disease progression during the study, which reduced the ability of a trial of this size to detect a treatment difference. This Phase 2a trial was not designed or powered to evaluate efficacy, and the sample size and exploratory analytic approach preclude efficacy conclusions.