Zafgen Inc. (NASDAQ: ZFGN) led the bulls early on Thursday following positive results of a clinical trial. The company announced 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.
This clinical trial achieved its primary efficacy endpoint, as treatment with the 1.8 mg and the 1.2 mg doses of beloranib resulted in 12.7% and 13.5% reductions in body weight, respectively, compared with a reduction of 3.1% for placebo. Patients enrolled in both treatment arms also met a key secondary endpoint as well.
At the end of January, Zafgen announced that the pivotal bestPWS ZAF-311 Phase 3 clinical trial of beloranib in Prader-Willi syndrome (PWS) had achieved its co-primary endpoints, demonstrating statistically significant and clinically meaningful weight loss and improvement in hyperphagia-related behaviors at both dose levels.
Thomas Hughes, Ph.D., CEO of Zafgen, commented on the results:
These results reinforce the strong efficacy profile of beloranib and further inform the potential of our MetAP2 inhibitor platform to impact metabolic disorders. 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.
We are actively working to better understand the mechanisms and incidence of underlying thromboembolic disease in PWS and severe obesity, as well as the potential impact of beloranib treatment on thrombosis in order to develop a strategy for risk mitigation.
So far in 2016, Zafgen has outperformed the broad markets, with the stock up 18% year to date. However, over the past 52 weeks, the stock is down 81%.
Shares of Zafgen closed Wednesday down 4.4% at $7.44, with a consensus analyst price target of $22.14 and a 52-week trading range of $5.34 to $55.36. In early trading indications on Thursday, the stock was up 10.9% at $8.25.