Infinity Pharma Provides 2014 Guidance; Announces Anticipated Pipeline Goals

(RTTNews) - Infinity Pharmaceuticals, Inc. (INFI) announced its anticipated pipeline goals and provided financial guidance for 2014. The company said it expects net loss for 2014 to range from $170 million to $180 million. During the year, Infinity expects to initiate at least three clinical studies of IPI-145, its oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, in patients with potentially fatal blood cancers, including DYNAMO +R, a Phase 3, randomized, placebo-controlled study of IPI-145 in combination with rituximab in patients with relapsed or refractory indolent non-Hodgkin lymphoma, or iNHL. In 2014, Infinity also plans to initiate a Phase 2 study of IPI-145 in treatment-naïve patients with iNHL and at least one additional clinical study of IPI-145 in patients with blood cancer.

In 2014, Infinity plans to expand the DUETTSTM program, the company's worldwide clinical investigation of IPI-145 in patients with blood cancer. As part of its DUETTSTM program, Infinity is currently enrolling patients in DYNAMOTM, a Phase 2 open-label study of IPI-145 in approximately 120 patients with refractory iNHL, and DUOTM, a Phase 3 randomized study of IPI-145 compared to ofatumumab in approximately 300 patients with relapsed/refractory chronic lymphocytic leukemia.

Infinity is evaluating the therapeutic potential of IPI-145 in rheumatoid arthritis and asthma. The company announced that it expects to report topline data from ASPIRA, its Phase 2, double-blind, placebo-controlled study in patients with moderate-to-severe RA, in 2014. The company also announced that it anticipates reporting topline data from its Phase 2a exploratory, randomized, double-blind, placebo-controlled study of IPI-145 in patients with mild, allergic asthma during 2014 following the completion of an additional cohort of patients.