Neumora pauses schizophrenia drug study after preclinical safety signal
15 Apr 2024
Phase 1Phase 2Phase 3
Shares in Neumora Therapeutics started the week down 17% after the company said the FDA placed a clinical hold on a Phase I trial of its schizophrenia drug hopeful NMRA-266. According to the biotech, the action was initiated following recently available preclinical data showing convulsions in rabbits dosed with the therapy.
NMRA-266, a positive allosteric modulator (PAM) of the M4 muscarinic receptor under development for schizophrenia and other neuropsychiatric disorders, was being evaluated in a Phase I single- and multiple-ascending-dose study. Neumora noted that approximately 30 participants have received doses so far, with no evidence of convulsions observed in any of them.
"We are disappointed with the unanticipated safety findings in rabbits and are discussing next steps with the FDA," said CEO Henry Gosebruch in a statement Monday. The setback forced Neumora to drop its previous timeline for NMRA-266. The company had expected data from the Phase I trial in healthy adults to be available in mid-2024, while a Phase Ib study in schizophrenia was due to start in the second half, with results anticipated next year.
Room for muscarinics
The setback stalls Neumora's efforts in the race to develop novel treatments for schizophrenia, a space that has several contenders already ahead. An FDA decision on KarXT (xanomeline-trospium), a muscarinic receptor agonistmuscarinic receptor agonist acquired by Bristol Myers Squibb, is expected by September 26, while Neurocrine Biosciences' M4 agonist NBI-1117568 is currently in Phase II.
AbbVie/Cerevel's investigational antipsychotic emraclidine, another M4 receptor PAM, is in mid-stage testing as well. In a note to clients last month, Stifel analysts suggested NMRA-266 "looks very similar to emraclidine preclinically… Though it's early, we should be able to see evidence of pharmacodynamic effect and while Neumora is behind other muscarinics in development, muscarinics in schizophrenia have the potential to be a blockbuster class with multiple players." For more, see – KOL Views Q&A: Leading psychiatrist sees a muscarinic revolution coming in schizophrenia and beyond.
Focus on KORA
Meanwhile, Gosebruch highlighted progress in other areas of the company's pipeline. "We anticipate several important milestones including Phase III data in major depressive disorder and the initiation of a Phase II study in bipolar depression with navacaprant, our kappa opioid receptor antagonist (KORA), and the initiation of a Phase Ib study in agitation in Alzheimer's disease with NMRA-511, our vasopressin 1a receptor antagonistvasopressin 1a receptor antagonist," he said.
RBC Capital Markets analyst Brian Abrahams said that “given the early stage and long path, we had not ascribed significant value to” NMRA-266, noting that back-up compounds in Neumora's M4 franchise are about 12 to 15 months behind in development. Abrahams added that navacaprant is seen as the company’s “core value driver” and “has a good probability of success” in Phase III.
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