Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today reported preclinical data for IPI-145, the company’s oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma. The data demonstrate potent PI3K-delta and -gamma inhibition in biochemical, cellular and whole blood assays and activity in multiple preclinical models of inflammatory disease, including rheumatoid arthritis and asthma. These data, which represent the first reported characterization of IPI-145, were presented at the New York Academy of Sciences event, “Inositol Phospholipid Signaling in Physiology and Disease,” held in New York City. “As these data demonstrate that IPI-145 is one of the most potent inhibitors of PI3K-delta and-gamma described to date, we believe that IPI-145 may have advantages over other PI3K inhibitors currently in development,” stated Vito J. Palombella, chief scientific officer at Infinity. “Inhibiting PI3K-delta and -gamma represents a potentially important therapeutic strategy for treating not only inflammation, but also hematologic malignances, and we are pleased to continue advancing IPI-145 in the clinic. Beyond IPI-145, we have an active discovery effort under way to build a portfolio of differentiated, isoform-specific PI3K inhibitors.” Infinity also announced today that it plans to initiate a Phase 2 trial of IPI-145 in patients with asthma as well as a Phase 2 trial of IPI-145 in patients with rheumatoid arthritis in the second half of 2012. Additional details about these trials will be provided when the studies commence. 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 involved in the development, function and trafficking of the immune system, making them potential therapeutic targets for both inflammatory disorders and hematologic malignancies. 2,3,4 IPI-145 is the only PI3K-delta and -gamma inhibitor currently in clinical development. Preclinical Data Presented at the New York Academy of Sciences Preclinical data presented today demonstrate that IPI-145 has picomolar affinity for PI3K-delta and -gamma, as well as potent isoform-specific in vitro activity in several cellular and whole blood assays. In addition, IPI-145 is highly selective for PI3K as compared to other lipid and protein kinases. Preclinical data also show that IPI-145 is active in an allergen challenge model of asthma. Additionally, in preclinical models of both collagen-induced arthritis and adjuvant-induced arthritis, IPI-145 inhibits ankle swelling and protects bone and cartilage in the joints of diseased animals. IPI-145 has also demonstrated activity in preclinical models of Crohn’s disease, systemic lupus erythematosus and multiple sclerosis. The presentation may be found in the Publications Archive on Infinity's website, http://www.infi.com/product-candidates-publications.asp. Planned Phase 2 Development The planned Phase 2 trials in asthma and rheumatoid arthritis follow the completion of a Phase 1 double-blind, randomized, placebo-controlled trial in healthy adult subjects, which assessed the safety, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of orally administered IPI-145. In the study, IPI-145 was well tolerated, with no clinically significant changes in clinical laboratory values or vital signs. In addition, an ex vivo pharmacodynamic assay demonstrated rapid, dose dependent, and durable inhibition of basophil activation at all dose levels. Infinity expects to present additional details from the Phase 1 study in healthy adult subjects at a medical meeting in the second half of 2012. “Our first Phase 2 trials in asthma and rheumatoid arthritis, development paths with well-defined endpoints, are designed to allow us to quickly explore the tolerability and clinical activity of IPI-145 and to inform our path forward in autoimmune and inflammatory diseases,” said Pedro Santabárbara, M.D., Ph.D., chief medical officer at Infinity. “We are pursuing a dual development strategy in both inflammation and hematologic malignancies. Our Phase 1, dose-escalation trial of IPI-145 in patients with advanced hematologic malignancies is ongoing, and we anticipate presenting data from this trial in the second half of 2012.”
About Infinity Pharmaceuticals, Inc.Infinity is an innovative drug discovery and development company seeking to discover, develop and deliver to patients best-in-class medicines for diseases with significant unmet need. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. Infinity’s programs focused on the inhibition of the heat shock protein 90 and phosphoinositide-3-kinase are evidence of its innovative approach to drug discovery and development. For more information on Infinity, please refer to the company’s website at www.infi.com. Forward Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include expectations regarding the advantages of IPI-145 over other PI3K inhibitors in development and the utility of PI3K-delta and -gamma inhibition as an important therapeutic strategy in inflammation and hematologic malignancies, as well as the expectation that Infinity will initiate Phase 2 clinical development of IPI-145 in asthma and rheumatoid arthritis in the second half of 2012 and that it will report data from the two Phase 1 clinical trials in the second half of 2012. Such statements are subject to numerous factors, risks and uncertainties that may cause actual events or results to differ materially from the company’s current expectations. For example, there can be no guarantee that Infinity’s strategic alliance with Mundipharma will continue for its expected term or that it will fund Infinity’s programs as agreed, that any product candidate Infinity is developing will successfully complete necessary preclinical and clinical development phases, or that development of any of Infinity’s product candidates will continue. Further, there can be no guarantee that any positive developments in Infinity’s product portfolio will result in stock price appreciation. Management’s expectations could also be affected by risks and uncertainties relating to: Infinity’s results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; Infinity’s ability to enroll patients in its clinical trials; unplanned cash requirements and expenditures, including in connection with business development activities; development of agents by Infinity’s competitors for diseases in which Infinity is currently developing its product candidates; and Infinity’s ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing. These and other risks which may impact management’s expectations are described in greater detail under the caption “Risk Factors” included in Infinity’s quarterly report on Form 10-Q for the quarter ended March 31, 2012, filed with the Securities and Exchange Commission on May 8, 2012. Any forward-looking statements contained in this press release speak only as of the date hereof, and Infinity expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
1 Weinberg RA (2007) Cytoplasmic signaling circuitry programs many of the traits of cancer. In Jeffcock E, Zayatz E and Mickey RK (Eds.) The biology of cancer (pp. 179-183). New York, NY: Garland Science, Taylor & Francis Group.2 Fung-Leung WP. Phosphoinositide 3-kinase delta (PI3Kδ) in leukocyte signaling and function. Cell Signal 2011, 23:603-608. 3 Schmid MC, Avraamides CJ, Dippold HC, Franco I, Foubert P, Ellies LG, et al. Receptor tyrosine kinases and TLR/IL1Rs unexpectedly activate myeloid cell PI3Kgamma, a single convergent poit promoting tumor inflammation and progression. Cancer Cell 2011, 19(6):715-727. 4 Billottet C, Banerjee L, Vanhaesebroeck B, Khwaja A. Inhibition of class I phosphoinositide 3-kinase activity impairs proliferation and triggers apoptosis in acute promyelocyctic leukemia without affecting atra-induced differentiation. Cancer Res 2009, 69(3):1027-1036.