Infinity Pharmaceuticals, Inc.’s (INFI) shares plunged 12.2% after the company announced duvelisib failed to meet the primary endpoint in a phase II study (ASPIRA). The company was developing duvelisib for the treatment of patients suffering from moderate-to-severe rheumatoid arthritis (RA).
The primary endpoint of the phase II study was an improvement of at least 20% in the American College of Rheumatology (ACR20) response rate over a treatment period of 12 weeks.
The double-blind, randomized, placebo-controlled phase II study (n=322) evaluated the efficacy, safety and pharmacokinetics of duvelisib across three doses (0.5 mg, 1.0 mg or 5.0 mg) twice daily with background methotrexate as compared to placebo plus methotrexate over a period of 12 weeks. The study was conducted on adult patients with active moderate-to-severe RA, who received a stable dose of methotrexate. Results from the study revealed that duvelisib missed the primary endpoint across all the three doses when compared to placebo.
Based on these results, Infinity Pharma has decided to discontinue the development of duvelisib in RA. We note that in Oct 2014, duvelisib had failed to achieve the primary endpoint in a phase II study in mild allergic asthma patients.
We are disappointed with the results from the RA study. However, the company will continue to evaluate duvelisib for the treatment of blood cancer. Currently, duvelisib is being evaluated in patients with previously treated follicular lymphoma (DYNAMO+R – phase III), patients with refractory indolent non-Hodgkin lymphoma (DYNAMO – phase II) and patients with relapsed/refractory chronic lymphocytic leukemia (DUO – phase III).
We note that Infinity Pharma has a collaboration with AbbVie (ABBV) for duvelisib. We remind investors that both companies had entered into an agreement for the development and commercialization of duvelisib for oncology indications.
We expect investor focus to remain on pipeline updates from the company.
Infinity Pharma currently carries a Zacks Rank #2 (Buy). Some better-ranked stocks in the health care sector include Biodel Inc. (BIOD) and Shire plc (SHPG). Both carry a Zacks Rank #1 (Strong Buy).
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