Zafgen Starts Phase 2 Trial Of Beloranib In Severe Obesity
By Cyndi Root
Zafgen, a company focusing on obesity and complex metabolic disorders, has begun a Phase 2 trial of beloranib. The company announced the trial initiation in a press release, stating that its lead product candidate treats patients with both severe obesity and type 2 diabetes. The study in Australia seeks to demonstrate the treatment’s efficacy in glycemic control and weight loss over 6 to 12 months. Dr. Thomas Hughes, Ph.D., CEO of Zafgen, said, “The trial aims to determine the long-term impact of beloranib on body weight, and will provide us with the opportunity to assess the compound's potential to impact medically important comorbid conditions, such as type 2 diabetes.”
Beloranib
Beloranib is an injectable small molecule therapy. It works to reduce the patient’s hunger while mobilizing fat stores to use as energy. The agent inhibits the enzyme MetAP2, which aids in modulating cellular processes and metabolism. Zafgen licensed beloranib from Chong Kun Dang Pharmaceutical Corp. from South Korea. Zafgen holds the worldwide rights for development and marketing except for South Korea. Early clinical trials showed that beloranib causes rapid weight loss averaging 2.2 lbs. per week, reductions in body fat, and improvements in cardiovascular risk factors.
Zafgen’s new trial is placebo-controlled study with twice weekly subcutaneous injections for 12 months. The company expects to enroll 150 people with a BMI between 30 and 60 kg/m2, who also have type 2 diabetes. The primary endpoint is the change in total body weight during the treatment period. Secondary endpoints are changes in glycemic control, lipid parameters, and inflammatory markers. Investigators will also measure quality of life and sense of hunger.
Obesity is a severe problem in developed countries, including the U.S. and the U.K. Zafgen states that the severely obese population is “among the most medically underserved populations globally.” The biological mechanisms of the condition are not well understood, but scientists believe that a person’s body may become programmed to store fat.
About Zafgen
Zafgen is focused on the underlying biological mechanisms of obesity and the MetAP2 pathway. The company, founded in 2005 and located in Cambridge, MA is also testing beloranib for Prader-Willi syndrome, obesity caused by hypothalamic injury, and craniopharyngioma-associated obesity. Zafgen states that it has 40 to 50 partners working together to develop new obesity treatments.