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Clinical trial

Zafgen starts Phase 2b Trial of Beloranib in severe obesity

The trial will aim to demonstrate weight loss over a 6-12 month period, along with improvements in glycaemic control, and is expected to enrol 150 patients at approximately 15 sites across Australia.

Zafgen has initiated a Phase 2b clinical trial with its lead product candidate, beloranib, in the treatment of patients with both severe obesity and type 2 diabetes. The trial is a randomised, double-blind, placebo-controlled design in severely obese adults with a BMI between 30-60 and type 2 diabetes. The trial will aim to demonstrate weight loss over a 6-12 month period, along with improvements in glycaemic control, and is expected to enrol 150 patients at approximately 15 sites across Australia.

Patients enrolled will be randomised to receive placebo, 1.2 mg or 1.8 mg of beloranib, twice weekly subcutaneous injections during the randomized treatment period of 12 months. The primary efficacy endpoint is change in total body weight from baseline to the end of randomised treatment. Key secondary endpoints include changes in glycaemic control, lipid parameters and inflammatory markers. Additional assessments include sense of hunger and quality of life impact for patients.

"We're very excited to announce the initiation of this Phase 2b trial of beloranib. 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," said Dr Thomas Hughes, Chief Executive Officer of the company. "We are eager to explore beloranib in this high-risk population of severely obese patients, for whom type 2 diabetes is a common and life-altering comorbidity."

Beloranib is a novel, first-in-class injectable small molecule therapy with a unique mechanism of action that reduces hunger while stimulating the use of stored fat as an energy source, the company claims. Beloranib is a potent inhibitor of MetAP2, an enzyme that modulates the activity of key cellular processes that control metabolism. MetAP2 inhibitors work, at least in part, by directing MetAP2 binding to cellular stress mediators, and, thus, reducing the tone of signals that drive lipid synthesis by the liver and fat storage throughout the body. In this manner, MetAP2 inhibition increases metabolism of fat as an energy source.

Zafgen holds exclusive worldwide rights (exclusive of South Korea) for the development and commercialization of beloranib. Zafgen exclusively licensed beloranib from Chong Kun Dang (CKD) Pharmaceutical Corp of South Korea.

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