Zafgen's Beloranib data pushed back to 2016
This article was originally published in Scrip
Executive Summary
During a fourth quarter earnings call on 19 March, Zafgen announced that data from a clinical trial of its lead asset – being studied in a rare metabolic disease – would not be available until early 2016 instead of later this year, as initially promised. Beloranib is a treatment for Prader-Willi Syndrome (PWS) and Zafgen began enrolling patients for its Phase III trial in September 2014. Due to slower than expected enrollment in the trial, the company was forced to move back its projections for topline data expectations. Currently all 15 clinical trial sites in the US are enrolling and active with the expectation that 102 patients will be included in the trial. Beloranib could eventually be used as a treatment for the morbidly obese, but Zafgen has been studying the drug in smaller sub-populations in hopes of proving its safety and efficacy on a small biotech's budget. The obesity drug developer hosted an initial public offering last June and a follow-on offering in January, raising $230m total, to support its metabolic disease pipeline (scripintelligence.com, 21 April 2014).