– Phase 2 Study of Duvelisib with Background Methotrexate in Patients with Moderate-to-Severe Rheumatoid Arthritis Did Not Meet Primary Endpoint –
– Infinity to Continue Focusing Its Efforts on the Development of Duvelisib in Blood Cancers –
CAMBRIDGE, MA, USA I January 8, 2015 I Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today 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 (RA) did not meet its primary endpoint. The primary endpoint was the ACR20 response rate at 12 weeks, which is defined as the proportion of patients who achieve at least a 20 percent improvement in American College of Rheumatology (ACR) response criteria after 12 weeks of study treatment.
Infinity will not proceed with any further clinical development of its PI3K inhibitors in rheumatoid arthritis. Infinity is continuing to focus on advancing duvelisib for the treatment of blood cancers and is conducting registration-focused studies of duvelisib in indolent non-Hodgkin lymphoma and chronic lymphocytic leukemia, forms of blood cancer for which there are no cures.
Study Details
This 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 (BID) for 12 weeks with background methotrexate compared to treatment with placebo plus methotrexate. The study evaluated 322 adults with active moderate-to-severe RA receiving a stable dose of methotrexate. The primary efficacy endpoint of the study was the ACR20 response rate at week 12.
An effect of duvelisib compared to placebo was not observed on the primary endpoint at any of the three dose levels tested. The majority of side effects observed were Grade 1-2, reversible or clinically manageable, and no new safety signals associated with duvelisib therapy were identified.
Infinity will continue to analyze the study results and expects to submit the data for publication in a peer-reviewed forum.
About Duvelisib
Duvelisib is an investigational inhibitor of Class I phosophoinositide-3-kinase (PI3K)-delta and PI3K-gamma that is being jointly developed by Infinity Pharmaceuticals, Inc. and AbbVie Inc. in oncology. The PI3K pathway is known to play a critical role in regulating the growth and survival of certain types of blood cancers. Duvelisib is designed to block the growth and survival of tumor cells by inhibiting PI3K-delta and PI3K-gamma signaling. The investigational agent is being evaluated in registration-focused studies, including DYNAMOTM, a Phase 2 study in patients with refractory indolent non-Hodgkin lymphoma, DYNAMO+R, a Phase 3 study in patients with previously treated follicular lymphoma, and DUOTM, a Phase 3 study in patients with relapsed/refractory chronic lymphocytic leukemia. Duvelisib is an investigational compound and its safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.
About Infinity Pharmaceuticals, Inc.
Infinity is an innovative biopharmaceutical company dedicated to discovering, developing and delivering best-in-class medicines to people with difficult-to-treat diseases. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. For more information on Infinity, please refer to the company’s website at www.infi.com.
SOURCE: Infinity Pharmaceuticals
