Infinity reports interim results from Phase 2 study of saridegib

The study’s independent Data Monitoring Committee concluded that the treatment with saridegib was similar to placebo and, hence, the trial would not meet its primary endpoint, the progression-free survival.

Based on the interim analysis, Infinity is stopping the trial in which saridegib was generally well tolerated.

Infinity research and development president Julian Adams said 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," Adams added.

The company will not proceed even with the Phase 2 exploratory trial of saridegib in patients with myelofibrosis, based on data from the initial cohort of 12 evaluable patients.

The level of clinical activity observed in the cohort did not satisfy the company’s pre-specified criteria for expansion, according to the company.