Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced interim data from its Phase 2, double-blind, randomized, placebo-controlled study of saridegib (IPI-926) in patients with metastatic or locally advanced, inoperable chondrosarcoma. The primary endpoint of the Phase 2 study was progression-free survival. While the final analysis is not complete, a planned futility analysis of data from the study was conducted by the study's independent Data Monitoring Committee and concluded that treatment with saridegib was similar to placebo and, therefore, the trial would not meet its primary endpoint. In the trial, saridegib was generally well tolerated. Based on this interim analysis, Infinity is voluntarily stopping the trial. The company expects to present the final data after all analyses are complete.
“We would like to acknowledge the patients and caregivers who have participated in these trials and thank them for their support”
Infinity also announced today that it will not continue its Phase 2 exploratory trial of saridegib in patients with myelofibrosis. This decision was made based on data from the initial cohort of 12 evaluable patients. The level of clinical activity observed in this cohort did not satisfy the company's pre-specified criteria for expansion.
"We would like to acknowledge the patients and caregivers who have participated in these trials and thank them for their support," stated Julian Adams, Ph.D., president of research and development at Infinity. "While preclinical data of saridegib have demonstrated activity in a broad range of malignancies, the clinical data to date have been disappointing. We continue to focus aggressively on the development of retaspimycin HCl and IPI-145."
Infinity has two trials are under way evaluating the clinical activity and safety of its novel heat shock protein 90 (Hsp90) inhibitor, retaspimycin hydrochloride (HCl) (IPI-504), in non-small cell lung cancer. With IPI-145, a potent, oral inhibitor of phosphoinositide-3-kinase (PI3K) delta and gamma, Infinity recently completed a Phase 1 trial in normal healthy volunteers and expects to begin Phase 2 development in inflammation in the second half of 2012. In addition, a Phase 1 trial of IPI-145 in patients with advanced hematologic malignancies is ongoing. Infinity anticipates reporting results from its Hsp90 and PI3K programs in the second half of 2012. No further company-sponsored trials evaluating saridegib are planned.
"While this news is disappointing, these disappointments are an inherent part of our business in the pursuit of transformative therapies. This is precisely why we have built a portfolio of drug candidates. Generating these data enable us to make important portfolio decisions and to focus on realizing the potential of retaspimycin HCl and IPI-145," stated Adelene Q. Perkins, president and chief executive officer at Infinity. "In addition, we have a strong financial foundation that enables us to advance our ongoing trials to key value inflection points while continuing to invest in our pipeline."
Saridegib, IPI-145 and Infinity's innovative discovery programs are part of Infinity's strategic alliance with Mundipharma International Corporation Limited. The relationship funds multiple programs and enables reallocation of committed research and development (R&D) funding between and across all programs in the alliance. As such, the committed R&D funding accessible to Infinity under the alliance remains unchanged. Under the strategic alliance agreement, Infinity is entitled to reimbursement for up to $110.0 million and $147.5 million in R&D expenses that are incurred by Infinity for covered programs during the years ending December 31, 2012 and 2013, respectively.
Infinity is evaluating its allocation of resources to IPI-145 and its early discovery programs in the context of these funding caps. The company continues to have cash runway until at least 2014. Infinity expects to provide an update on its other 2012 financial guidance when it reports its second quarter financial results, planned for August 2012.
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