Zafgen, Inc., a biopharmaceutical company focused on therapies for obesity and complex metabolic disorders, recently announced a clinical update on its product candidate beloranib.
Beloranib is a first-in-class, twice-weekly, subcutaneous injectable agent that can reduce hunger while it stimulates the use of stored fat as an energy source. Beloranib acts by strongly inhibiting MetAP2, an enzyme that regulates the activity of key cellular metabolic processes, ultimately leading to a reduction in lipid synthesis by the liver and fat storage in the body. Beloranib has been developed as a therapy for several indications associated with severe obesity, including type 2 diabetes and a rare disease called Prader-Willi syndrome (PWS, a genetic disease characterized by constant and unrelenting hunger).
Beloranib safety and efficacy is currently being evaluated in clinical trials. Now, upon analyzing the trials design and data collected so far, Zafgen decided to stop earlier the randomization process of the Phase 3 ZAF-311 clinical trial assessing beloranib in PWS patients and the Phase 2b clinical trial ZAF-203 evaluating beloranib in patients with severe obesity complicated by type 2 diabetes. The decision was made based on the fact that, according to the company, a sufficient number of patients have completed randomized treatment in both clinical trials.
“The strategic decision to analyze results from the ZAF-311 and ZAF-203 clinical trials early allows us to better preserve data integrity by limiting dose interruption in both clinical trials, and inform the future development of this important product candidate,” said Dr. Dennis Kim, the Chief Medical Officer of Zafgen, in a press release. “PWS is a life-threatening and complex rare disorder that severely impacts the quality of life of both patients and their families, and we continue to believe that beloranib may have an important role in addressing hyperphagia and underlying obesity associated with this disorder.”
The company expects to disclose data on both ZAF-311 and ZAF-203 clinical trials in the first quarter of 2016.
“Patient safety is paramount and we will continue to work with regulators on current and future clinical trials of beloranib. Beloranib has demonstrated important clinical outcomes in patients with complicated and severe obesity,” concluded Dr. Thomas Hughes, Chief Executive Officer of Zafgen. “We look forward to analyzing results from our ZAF-311 and ZAF-203 clinical trials, and to advancing our programs.”