A drugmaker developing therapies for metabolic diseases suffered its second major regulatory setback in three years as the Food and Drug Administration placed a hold on its lead drug candidate before it had even left the gates for clinical testing.
Boston-based Zafgen said Monday the FDA had sent it a letter last week imposing a clinical hold on its investigational new drug application, or IND, for ZGN-1061. The drug was to begin clinical development for Type 2 diabetes. Shares of Zafgen were down more than 40 percent in midday trading following the news.
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The clinical hold mirrors that of another drug the company had been developing in the same class. Like ZGN-1061, beloranib was a MetAP2 inhibitor, which the company had been developing for Type 2 diabetes and severe obesity. The FDA placed a full clinical hold on that drug, which was in Phase III development, in December 2015. The hold affected an ongoing open label extension portion of beloranib’s registration-directed trial in patients with Prader-Willi syndrome, a genetic disorder that causes obesity.
In placing its hold on ZGN-1061, the FDA cited the risk to patients’ cardiovascular safety, based on the experience with beloranib. However, the agency outlined potential clinical and nonclinical paths to move forward and address the concerns it raised. The company said it plans to assess those options and request a Type A meeting with the FDA to discuss next steps.
Meanwhile, Phase II development of the drug outside the US has continued, and the study recently finished dosing, including at the 1.8mg level, with no cardiovascular events observed. The company expects to report topline data early next year.
In response to the 2015 hold, the company said in July 2016 that it would refocus its resources on the development of ZGN-1061, which was meant as the successor to beloranib. The company said that based on the greater complexity and cost associated with beloranib’s development, ZGN-1061 offered a more robust long-term opportunity.
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