Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced new data from its completed Phase 1 study of IPI-145, the company’s potent, oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma. The data showed that IPI-145 was well tolerated and demonstrated favorable pharmacokinetics following administration of single and multiple doses in healthy adult subjects. Infinity also presented data demonstrating the activity of IPI-145 in preclinical models of rheumatoid arthritis (RA). These findings were presented at the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) 2012 Annual Meeting held in Washington, DC.
“These data show that IPI-145 is well tolerated in healthy subjects and inhibits immune cell activation even at low doses,” stated Vito J. Palombella, chief scientific officer at Infinity. “The profile of IPI-145 observed in this Phase 1 trial, combined with our preclinical studies in inflammation, support Phase 2 clinical development in patients with asthma and RA as well as other potential inflammatory indications.”
The PI3Ks are a family of enzymes involved in multiple cellular functions, such as cell proliferation and survival, metabolism, cell differentiation and cellular trafficking. 1 PI3K-delta and -gamma, two isoforms of PI3K, are necessary for adaptive and innate immunity, and the role of these enzymes in various immune cells supports the development of IPI-145 for the treatment of inflammatory disorders as well as hematologic malignancies. 2 Infinity believes that IPI-145 is the only PI3K-delta and -gamma inhibitor currently in clinical development.
Data Presented at ACR/ARHPThe Phase 1, double-blind, randomized, placebo-controlled trial of IPI-145 in healthy adult subjects evaluated single doses of IPI-145 ranging from 1 mg to 30 mg. Multiple doses of IPI-145 ranging from 1 mg twice daily (BID) to 5 mg BID for 14 days and 10 mg once daily (QD) for 14 days were also evaluated. In addition, the effect of food on the pharmacokinetics of IPI-145 was studied. One hundred six patients were enrolled in the Phase 1 trial.