Former Biogen executive Priya Singhal, M.D., M.P.H., has joined Zafgen as its new head of research and development. She comes to the role after helping shepherd several programs toward regulatory filings and approvals, including multiple sclerosis drug Tecfidera and spinal muscular atrophy treatment Spinraza.
At Biogen, Singhal served as a senior vice president, global head of safety and benefit risk management and interim global co-lead and SVP of global development. In addition to leading the benefit-risk strategy for Biogen’s portfolio, she also worked on the company’s overall R&D strategy and drug development plans, chaired safety governance and led interactions on several products with regulators worldwide.
Singhal will lead Zafgen’s research, clinical and manufacturing strategy. The company’s portfolio is based on inhibiting the MetAP2 pathway. It has one clinical-stage asset, ZGN-1061, for the treatment of Type 2 diabetes, and two preclinical programs: ZGN-1258 for Prader-Willi syndrome and ZGN-1345 for an undisclosed liver indication.
“Throughout my career I have been drawn to opportunities to lead translation from new scientific insights into safe and effective treatments that make a difference for patients and their families,” she said in a statement. “Zafgen is highly scientific and patient-centric in its approach. I am excited to collaborate with this dedicated team and bring my experience across the drug development life cycle to guide the R&D strategy and realize the full potential of this pathway.”
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“Priya is a seasoned and exceptional industry leader, and we are thrilled to welcome her to Zafgen to support the development of second-generation MetAP2 therapies for patients with complex metabolic disorders,” said Zafgen CEO Jeffrey Hatfield in the statement. “Her extensive experience leading strategy around innovative, first-in-class development programs includes driving critical nonclinical and clinical decisions and regulatory interactions.”
It hasn’t always been smooth sailing for the Boston-based biotech, though. In 2016, it abandoned its lead program at the time, an obesity treatment dubbed beloranib, after two patients died in a phase 3 study. The data showed that patients who received the drug had a greater tendency to develop blood clots.
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Zafgen started turning it around the next year with encouraging phase 1 data for its diabetes treatment, ZGN-1061. The company had billed the drug as a second-generation MetAP2 inhibitor that avoids the thrombotic side effects of beloranib, and the phase 1 data backed up that claim. The data showed "no evidence of prothrombotic effects,” and patients also shed weight at a rate of around one pound per week and seemed to have improved blood sugar control.
But Zafgen didn’t manage to allay the FDA’s concerns about the cardiovascular side effects of ZGN-1061: the agency placed a clinical hold on the IND for the drug in November last year. At the time, Zafgen said it was assessing the “multiple potential paths for moving forward, including nonclinical or clinical options” proposed by the FDA ahead of a meeting with the agency, but otherwise offered few clues as to how long the hold might last.