12:00 AM
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Jul 22, 2013
 |  BioCentury  |  Product Development

Biggest loser

First Phase II data from Zafgen hint at efficacy on par with bariatric surgery

Preliminary Phase II data for Zafgen Inc.'s beloranib provide the first clinical support for the company's hypothesis that the compound could compete with bariatric surgery to treat obesity.

While the data cover only a handful of patients treated for 12 weeks, two clinicians told BioCentury the trends suggest beloranib could provide weight loss greater than recently approved obesity drugs, and equal to or better than bariatric surgery.

The co-primary endpoints were safety and tolerability, and weight loss.

Preliminary data from 19 females with a mean BMI of 37.9 kg/m2 showed twice-weekly subcutaneous injections of 0.6, 1.2 or 2.4 mg beloranib led to mean reductions in total body weight of 3.8, 6.1 and 9.9 kg from baseline compared with a 1.8 kg weight gain for patients on placebo (p<0.05 for all doses).

Placebo-corrected weight reductions were -5.5%, -7.7% and -12.2% for the three doses.

Patients showed improvements in serum lipid profiles, including reductions in circulating LDL, as well as improvements in a range of biomarkers associated with cardiovascular disease risk and inflammation, including leptin, adiponectin and C-reactive protein (CRP).

There were no serious adverse events. The most common side effects were GI-related, including diarrhea, nausea and vomiting.

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