A 'high-risk, high-reward' effort on NGF pain med fasinumab by Regeneron, Teva clears a revised PhIII -- serious questions linger
Just a few months after Regeneron $REGN and its partners at Teva $TEVA were forced to drop the two high-dose arms of their Phase III study of the NGF pain med fasinumab, researchers say the remaining two low-dose arms cleared a late-stage hurdle, opening the way to more Phase III trials as they hunt an elusive approval for a brand new class of pain therapies.
This one isn’t easy.
Just a few months ago the top team at Regeneron uneasily acknowledged in a Q1 call with analysts that the independent monitoring board had told them to shelve the two highest doses in the study, citing concerns about the risk/benefit profile. Once a darling in Big Pharma circles, NGF drugs were tied to severe adverse events that forced a lull in trial work from 2012 to 2015, until researchers could persuade regulators that they could test it without threatening patients. And Regeneron and Teva have already endured a clinical hold for their program, which came right after Teva paid $250 million to partner on the therapy.
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