Infinity Pharma: Duvelisib Phase 2 Study Fails To Meet Primary Endpoint

(RTTNews) - Infinity Pharmaceuticals Inc. (INFI) announced that ASPIRA, a Phase 2 study of duvelisib, an oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, with background methotrexate in patients with moderate-to-severe rheumatoid arthritis did not meet its primary endpoint. Infinity said it will continue to analyze the study results and expects to submit the data for publication in a peer-reviewed forum.

The Phase 2, double-blind, randomized, placebo-controlled study was designed to evaluate the efficacy, safety and pharmacokinetics of duvelisib dosed at either 0.5 mg, 1.0 mg or 5.0 mg twice daily for 12 weeks with background methotrexate compared to treatment with placebo plus methotrexate. The primary efficacy endpoint was the ACR20 response rate at week 12.

The company reported that an effect of duvelisib compared to placebo was not observed on the primary endpoint at any of the three dose levels tested. No new safety signals associated with duvelisib therapy were identified.