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Australian beloranib trial

Zafgen completes enrolment for Australian beloranib trial

Credit: e-Magine Art/Flickr
The primary efficacy endpoint is change in total body weight at six months of randomised treatment
The company expects to release six-month interim data in a subset of 95 patients in late 2015 or very early 2016

Zafgen has completed enrolment of ZAF-203, a Phase 2b clinical trial of beloranib in the treatment of patients with both severe obesity and type 2 diabetes. The trial enrolled 152 patients across 16 sites in Australia. ZAF-203 is a Phase 2b clinical trial designed to determine the long-term weight loss benefits of MetAP2 inhibitor treatment with beloranib in patients with severe obesity complicated by type 2 diabetes, which began randomized treatment in December 2014.

"We're very pleased to announce that we have completed enrollment for our Phase 2b study in this high risk population of obese patients complicated by type 2 diabetes inadequately controlled by other agents," said Dr Thomas Hughes, CEO of Zafgen. "We look forward to seeing the impact of beloranib treatment on body weight and glycaemic control, among other endpoints. This study provides our first view of the drug's potential to provide changes in the range of those seen following bariatric surgery."

The trial aims to demonstrate efficacy and safety over a 12 month period, with an interim six-month analysis. Patients in the study are randomised to receive twice weekly subcutaneous injections of placebo, 1.2mg or 1.8mg of beloranib during the treatment period of 12 months. The primary efficacy endpoint is change in total body weight at six months 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.

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. Beloranib is a potent inhibitor of methionine aminopeptidase 2, or 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.

The baseline characteristics of the study population on average are as follows: 54 years of age, BMI40, body weight of 115kg, HbA1c of 8.3% and fasting glucose of 193 mg/dl, with 43% of the patients being female.

"The baseline characteristics of patients in this trial meet our expectations. The population being studied is poorly controlled, at high risk of developing serious medical complications, and in need of improved therapies providing clinically significant weight loss and glycaemic control," said Dr Dennis Kim, Chief Medical Officer of Zafgen.

The company expects to release six-month interim data in a subset of 95 patients in late 2015 or very early 2016.

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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