Infinity Pharmaceuticals Inc. to Stop Developing Rheumaid Arthritis Drug
Published: Jan 09, 2015
January 8, 2015
By Krystle Vermes, BioSpace.com Breaking News Staff
Cambridge, Mass.-based Infinity Pharmaceuticals, Inc. , announced today that its Phase II study of duvelisib, an oral inhibitor of phosphoinositide-3-kinase-delta and PI3K-gamma, did not meet its primary endpoint. The drug was being tested in patients with moderate-to-severe rheumatoid arthritis. As a result of this data, Infinity has decided not to continue developing its PI3K inhibitors.
The primary endpoint was the ACR20 response rate at 12 weeks. This was defined as the proportion of patients who achieved at least a 20 percent improvement in American College of Rheumatology response criteria after participating in the study for 12 weeks.
Infinity noted that it will continue to look into duvelisib as a form of treatment for blood cancers. It will also conduct registration-focused studies of the drug in indolent non-Hodgkin lymphoma and chronic lymphocytic leukemia.
The Phase 2 study of duvelisib was a double-blind, randomized, placebo-controlled study that looked at the efficacy and safety of the drug dosed at either 0.5 mg, 1.0 mg or 5.0 mg twice per day for 12 weeks. Duvelisib is designed to block the growth and survival of tumor cells by inhibiting PI3K-delta and PI3K-gamma signaling. It is an investigational compound, and its safety and efficacy have not been evaluated by the U.S. Food and Drug Administration.
Looking at Duvelisib for Asthma
In October 2014, Infinity Pharmaceuticals released the results of its Phase IIa exploratory study of duvelisib for the treatment of mild, allergic asthma. The data from the study showed that the drug was well tolerated and met several secondary endpoints.
“This is the first clinical study to suggest that inhibition of PI3K-delta and PI3K-gamma plays a role in improving lung function for patients with asthma,” said Julian Adams, president of research and development at Infinity. “In this exploratory study, duvelisib showed evidence of activity across several important clinical measures, including improvement in the late-phase asthmatic response and significant corresponding changes in several key mediators of airway inflammation. These data support further development of PI3K-delta,gamma inhibitors in more severe forms of asthma, for which there is a medical need.”
The primary endpoint of the study was defined as significantly improving the maximum early-phase or late-phrase asthmatic responds as measured by FEV, a standard lung function test that measures the amount of air that can be exhaled in one second. It was not met, as it did not reach statistical significance. However, improvement in the late-phase response was observed at the 25 mg twice daily dose.