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ZAF-203 trial results

Beloranib severe obesity T2DM trial results

Beloranib demonstrates statistically and clinically significant improvements in body weight and glycaemic control over six months of randomised treatment

Zafgen has revealed positive efficacy results from its Phase 2b ZAF-203 clinical trial evaluating beloranib, a MetAP2 inhibitor, in the treatment of severe obesity complicated by type 2 diabetes. The clinical trial achieved its primary efficacy endpoint, as treatment with the 1.8mg and the 1.2mg doses of beloranib resulted in 12.7 percent (p<0.0001) and 13.5 percent (p<0.0001) reductions in body weight, respectively, compared with a reduction of 3.1 percent for placebo. Patients enrolled in both the 1.8mg and 1.2mg treatment arms also met a key secondary endpoint, with patients in each dose arm achieving on average an absolute reduction in HbA1c of 2.0 percent, compared to a reduction of 0.6 percent for placebo.

"These results reinforce the strong efficacy profile of beloranib and further inform the potential of our MetAP2 inhibitor platform to impact metabolic disorders," said Dr Thomas Hughes, Chief Executive Officer of Zafgen. "In addition to the recent positive efficacy data from our bestPWS clinical trial, these data provide additional context regarding beloranib's benefit-risk profile in the treatment of severe forms of obesity. We look forward to discussing these results with the FDA as we work to establish a path forward for beloranib in Prader-Willi syndrome and other orphan obesity indications."

In the ZAF-203 clinical trial, 152 patients were randomized and received twice-weekly subcutaneous injections of either 1.8mg or 1.2mg of beloranib or placebo, in addition to a diet and exercise regimen. Sixty-six patients comprised the pre-specified primary analysis population, completing six months of treatment in compliance with the protocol prior to the company's suspension of dosing in the trial at the time of the partial clinical hold in October 2015.

"Obesity complicated by type 2 diabetes represents a serious public health concern with limited treatment success," said Dr Joseph Proietto, Professor Emeritus at the University of Melbourne. "The compelling and clinically meaningful efficacy results of this long-term study demonstrate beloranib's unique mechanism of action and further validate investigation of MetAP2 inhibition as a potential treatment for obesity disorders and related co-morbidities, particularly in this difficult-to-treat population."

The most common adverse events (AEs) in the clinical trial were upper respiratory tract infection, diarrhoea, and injection site bruising. These were generally mild and transient in nature and occurred at comparable incidence rates between beloranib and placebo treated patients. Ten patients in the beloranib groups (five in each of the 1.8mg and 1.2mg groups) withdrew due to AEs compared to two patients in the placebo group.

Consistent with prior beloranib clinical trials in conventional obesity, the most common causes of AEs leading to early withdrawal were sleep related, leading to four withdrawals from the clinical trial. In the clinical trial, there were a total of nine serious adverse events (SAEs) identified in eight patients, one in the 1.8mg group, six in the 1.2mg group, and two in the placebo group. As previously disclosed, one of the SAEs was a pulmonary embolism in the 1.2mg treatment group. During the VTE screening process that followed the FDA's partial clinical hold of the beloranib IND in October 2015, two additional VTEs were identified in patients in this clinical trial: deep vein thrombosis in a patient who had received 1.8mg of beloranib, and superficial thrombophlebitis in a patient who had received 1.2mg of beloranib.

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

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