The FDA has halted a phase 1 trial of Neumora Therapeutics’ treatment for schizophrenia after preclinical investigations uncovered instances of convulsions in rabbits who had been administered the drug.
Thus far, 30 healthy adult participants have got doses of NMRA-266, identified as a positive allosteric stimulator of the M4 muscarinic receptor, within the single and multiple increasing dose phase 1 study. Neumora emphasized that no participant showed any signs of convulsions.
The biotech company stated that it is actively working with the FDA to address the issue and will provide further information once progress is made.
The company has been dedicated to advancing NMRA-266 as a prospective therapy for schizophrenia and various other neuropsychiatric conditions. Originally, the phase 1 trial results were anticipated to be available in 2024. Additionally, a separate phase 1b study targeting patients with schizophrenia had been slated to commence in the latter half of the year.
In the release, CEO Henrey Gosebruch remarked, “We are disappointed with the unanticipated safety findings in rabbits and are discussing next steps with the FDA. In parallel, we’re continuing to make significant progress across the rest of our portfolio as we seek to fulfill our mission to develop medicines for serious brain diseases.”
Despite being one of the few biotech IPO hits of 2023, Neumora has encountered challenges with FDA regulations in the past regarding its therapies. The company withdrew its obstructive sleep apnea candidate NMRA-094, acquired through its Alairion acquisition, following feedback from the FDA.
Moreover, a phase 1 trial of its V1aR antagonist NMRA-511 initially faced a partial clinical hold due to dose-restraining impacts such as tremor and spasms. However, NMRA-511 has since progressed to clinical trials.
In the current statement, Gosebruch referenced NMRA-511 along with the company’s lead asset, navacaprant, which is undergoing late-stage trials for major depressive disorder.
Gosebruch said in the morning statement that they expect many significant milestones, including phase 3 evidence in major depressive illness and the commencement of a phase 2 study in bipolar episodes with navacaprant, their kappa opioid receptor antagonist. Additionally, the firm anticipates the start of a phase 1b trial in agitation in Alzheimer’s illnesswith NMRA-511.
Despite Gosebruch’s assurance of forthcoming positive developments, Neumora’s stock saw a decline of 13% to $11.84 in premarket trading on Monday, down from Friday’s closing price of $13.56.
The company generated $250 million through its IPO in September 2023, initially priced at $17 per share.
Analysts at William Blair remarked that the clinical hold would further delay NMRA-266, placing it at a disadvantage compared to Karuna’s highly publicized schizophrenia treatment, KarXT, recently acquired by Bristol Myers Squibb, and Neurocrine’s M4 agonist, NBI-1117568.
The analysts said that although the hold could potentially be resolved, and the company has alternative compounds available if needed, the primary area of attention for investors continues to be the company’s lead program, navacaprant.
