FDA slaps hold on Neumora’s Phase I trial of NMRA-266
The Phase I trial of NMRA-266 has been placed on clinical hold by the US Food and Drug Administration (FDA), said the drug’s developer, Massachusetts, USA-based based brain disease biotech Neumora Therapeutics (Nasdaq: NMRA), whose shares tumbled 17.5% to $11.18 in early trading today.
NMRA-266 is a positive allosteric modulator (PAM) of the M4 muscarinic receptor and is part of the company’s M4 PAM franchise. The clinical hold determination follows recently available pre-clinical data showing convulsions in rabbits.
As a result, Neumora said that the Phase I single ascending dose / multiple ascending dose study with NMRA-266 has been paused. About 30 participants have been dosed in the Phase I study, with no evidence of convulsions observed in any participant.
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