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Regeneron’s Fasinumab Brings Second Clinical Hold For Anti-NGF Class

 
• By Joseph Haas

One case of adjudicated arthropathy seen in halted Phase IIb study of anti-NGF candidate. Regeneron still hopes to advance fasinumab, partnered with Teva, into Phase III in osteoarthritis and chronic low back pain – but the second clinical hold for the class puts its future into even greater question.

Despite FDA putting a second clinical hold on its anti-NGF candidate fasinumab, Regeneron Pharmaceuticals Inc. and partner Teva Pharmaceutical Industries Ltd., which signed on just last month, expect to move into Phase III with a refined indication and adjusted dosing.

The anti-nerve growth factor (NGF) class has been fraught with safety issues – the entire class was placed on clinical hold by FDA in 2010 after Pfizer Inc./Eli Lilly & Co. candidate tanezumab was associated with worsening of arthritis that led to joint replacements. Investigation of the class was permitted to resume in 2012, but fasinumab and tanezumab are the only such candidates currently in clinical development. (Also see " US FDA panel: Let anti-NGF studies move forward, despite 'severe' joint risks " - Scrip, 13 March, 2012.) Amgen Inc.’s fulranumab, which had been partnered with Johnson & Johnson, was shelved this past May following a portfolio review, but not due to safety, the company said, while AbbVie Inc. deprioritized its ABT-110 in March due to regulatory concerns

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