NA (not applicable)The Phase 1 study poster is being presented in the Georgia World Congress Center, Hall B1-B2, and may also be found in the Publications Archive on Infinity’s website http://www.infi.com/product-candidates-publications.asp. Additional Program Updates Infinity today also provided the following updates related to its PI3K program:
- Continued progress anticipated in Phase 1 dose-escalation trial of IPI-145: Based on data observed to date, Infinity expects to expand its ongoing Phase 1 study of IPI-145 in up to five cohorts based on responses observed during the dose-escalation phase at or below the maximum tolerated dose.
- Update on Phase 2a trial in asthma: Infinity is currently conducting a Phase 2a, randomized, double-blind, placebo-controlled trial of IPI-145 in approximately 30 patients with mild, allergic asthma. Endpoints of this multi-dose, two-way crossover study include safety, pharmacokinetics and FEV1, a standard measure of lung function. The company expects to provide an update on this study in 2013.
- Planning for Phase 2 trial in RA continuing: In November 2012, Infinity presented data from its completed Phase 1 trial of IPI-145 in healthy subjects. Infinity believes that these data, combined with preclinical data in multiple animal models of rheumatoid arthritis (RA), support Phase 2 development in this indication. Infinity expects to begin a Phase 2 trial of IPI-145 in patients with moderate to severe RA in the first half of 2013.
- Follow-on PI3K inhibitor expected: Infinity is developing a portfolio of novel PI3K-delta and/or PI3K-gamma inhibitors. The company expects to announce its first follow-on PI3K development candidate by the end of this year and is planning to complete nonclinical studies by the end of 2013, which are designed to enable Phase 1 development.