Shares of Zafgen Inc ZFGN 18.2% were tumbling below the psychological barrier of $2 in Thursday’s session.
What Happened
Boston-based Zafgen, which focuses on developing therapies for metabolic diseases, announced the receipt of the minutes of a Type A meeting that was held with the FDA regarding a previously imposed clinical hold on its ZGN-1061.
ZGN-1061 is a MetAP2 inhibitor that is being evaluated for Type 2 diabetes. The FDA placed a clinical hold on the IND application for the U.S. trial in November 2018, citing possible cardiovascular risk.
Following the receipt of the minutes, Zafgen said it is working with the FDA to agree upon on an in vivo animal model to confirm relevant safety margins in a bid to resolve the clinical hold.
Prior to the meeting, the company said it submitted newly developed in vitro assays of human plasma coagulation using endothelial cells and assessment of tissue factor expression with endothelial cells and other supporting new assays to the FDA.
Why It’s Important
Zafgen had to pull the plug on a predecessor drug being evaluated for obesity, beloranib, following patient deaths in a late-stage trial.
It’s déjà vu all over again for Zafgen, as ZGN-1061 is plagued by safety concerns.
The company is optimistic.
“We believe the new in vitro data generated was encouraging, and the FDA was helpful with guidance regarding data needed to move forward in type 2 diabetes,” Zafgen CEO Jeffrey Hatfield said in a statement.
What’s Next
Zafgen said it is evaluating serious, rare disease indications for which ZGN-1061 could be useful.
The FDA was supportive of Zafgen seeking guidance on a second investigational new drug application for ZGN-1061 as appropriate.
Zafgen is set to provide an update on development plans by the end of the third quarter.
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