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Beloranib, a prospective obesity drug, scores highly in phase II trial by Zafgen
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Zafgen Inc. has released positive Phase II trial data on a prospective new obesity drug, beloranib, which is a selective inhibitor of methionine aminopeptidase 2 (MetAP2). The trial was a randomized, double-blind, placebo-controlled trial carried out on 147 severely obese individuals, mainly women, over twelve weeks to measure efficacy and safety. Patients ate normally during the trial and did not modify their exercise routine.

The trial data indicated significant weight loss and cardiometabolic risk marker improvements. This positive efficacy outcome was in conjunction with reassuring safety data. In fact, the drug triggered improvements in systolic blood pressure. There were no serious adverse events (AEs) reported to be due to the drug and no clinically significant abnormal laboratory measures, vital signs, or electrocardiography (ECG) findings. Some more minor adverse events such as nausea, diarrhoea, headache, injection site bruising, and insomnia were reported but were generally transient. Insomnia at the higher doses, however, caused some patients to drop out.

Obesity is a public health issue that has become extremely problematic in the developed world. While the benefits of a healthy diet and exercise regime are promoted in public health campaigns, once a person becomes obese, their fat metabolism changes so that they store more and more fat, making it increasingly difficult to lose weight. Beloranib is a novel compound which is designed to target methionine aminopeptidase 2 (MetAP2), a key enzyme in the fat metabolism process which controls the production and utilization of fatty acids. MetPA2 inhibitors work in various ways, for example by reducing feelings of hunger but also by reducing new fatty acid molecule production by the liver and assisting in fat conversion to energy. Beloranib is being developed as a twice-weekly subcutaneous injection for severe obesity.

The next step for Zafgen is to conduct a 6-12 month Phase IIb study in 2014 with a group of about 200 patients to allow fine-tuning of the dosage and observation of long-term impact on weight and blood pressure. The company are also already carrying out a study on Prader – Willy syndrome patients who experience insatiable hunger to be completed later this year or early in 2014. If results continue to be positive for Beloranib it should offer new hope for obese patients.

Sources

http://www.prnewswire.com/news-releases/...40651.html (Zafgen press release) [Accessed 15 November 2013].

http://www.fiercebiotech.com/story/zafge...2013-11-15 [Accessed 15 November 2013].
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