The FDA has placed Neumora’s schizophrenia medication on hold due to reports of convulsions in rabbits. Neumora Therapeutics’ phase 1 study aimed at treating schizophrenia has been halted by the FDA following preclinical findings indicating convulsions in rabbits administered the medication.
Thirty healthy adult individuals received doses of NMRA-266, a positive allosteric modulator of the M4 muscarinic receptor, as part of the single and multiple-ascending-dose phase 1 trial. Neumora stressed that none of these individuals displayed any signs of seizures. The biotech company stated that it is collaborating with the FDA to resolve the clinical hold and will provide updates as soon as possible.
NMRA-266 is a medication being developed by the company for treating neuropsychiatric illnesses, including schizophrenia. The readout for the phase 1 trial was scheduled for 2024, with phase 1b research involving patients with schizophrenia expected to commence later in the year. CEO Henry Gosebruch expressed disappointment over the unforeseen safety issues discovered in rabbits during the announcement on April 15. He mentioned ongoing discussions with the FDA regarding the next steps. Despite this setback, he emphasized the company’s dedication to advancing medicines for severe brain conditions while noting substantial progress in other areas of their portfolio. Although Neumora was one of the few biotech IPO success stories of 2023, the company’s medicines have previously encountered issues with the FDA.
Following feedback from the FDA, the company had already discontinued NMRA-094, an obstructive sleep apnea treatment acquired as part of the Alairion merger. The FDA initially placed a phase 1 study of its V1aR antagonist, NMRA-511, on partial clinical hold due to dose-limiting effects such as convulsions and tremors. Gosebruch mentioned NMRA-511, now undergoing clinical testing, and navacaprant, the company’s flagship product undergoing a late-stage study for major depressive disorder.
The CEO stated that the company expects to reach several important milestones, including phase 3 data in major depressive disorder, the initiation of a phase 2 study in bipolar depression with the kappa opioid receptor antagonist navacaprant, and the initiation of a phase 1b study in agitation in Alzheimer’s disease with the vasopressin 1a receptor antagonist NMRA-511. Despite Gosebruch’s assurances of more positive news to come, investors knocked Neumora’s stock down 13% to $11.84 in premarket trading on Monday from its closing price of $13.56.
In September 2023, the firm went public for $17 per share, raising $250 million. Analysts at William Blair predicted that the hold would further delay NMRA-266, trailing behind Neurocrine’s M4 agonist NBI-1117568 and Karuna’s well-discussed schizophrenia therapy KarXT, which was recently acquired by Bristol Myers Squibb.
