Neumora Therapeutics' Phase 1 Trial of NMRA-266 Suspended by FDA

April 15, 2024 —Neumora Therapeutics, a biopharmaceutical firm listed on Nasdaq as NMRA, has encountered a setback in its clinical trials. The FDA has imposed a clinical hold on the Phase 1 trial of their drug candidate, NMRA-266, after pre-clinical rabbit studies indicated convulsions. This compound, which is a positive allosteric modulator (PAM) of the M4 muscarinic receptor, is a key component of the company's M4 PAM franchise. 

Despite the pause in the Phase 1 study involving single and multiple ascending doses, no convulsions have been reported among the approximately 30 participants who have been administered the drug. The company is in active dialogue with the FDA to address the clinical hold and is unable to provide previous guidance on NMRA-266 until further notice. Neumora's M4 PAM franchise encompasses a variety of novel compounds, each with distinct properties and chemical structures. These compounds have shown promising preclinical results, high receptor subtype selectivity, and the potential for once-daily oral dosing. The company is progressing with preclinical safety and toxicology assessments for these compounds, with an IND submission anticipated for 2025. 

Henry Gosebruch, Neumora's CEO, expressed disappointment over the safety findings but remains optimistic about the company's broader pipeline. He highlighted upcoming milestones, including Phase 3 data for major depressive disorder, a Phase 2 study for bipolar depression with navacaprant, a kappa opioid receptor antagonist, and a Phase 1b study for agitation in Alzheimer's disease with NMRA-511, a vasopressin 1a receptor antagonist. Neumora is dedicated to developing innovative treatments for brain diseases through a unique approach to neuroscience drug development. The company's pipeline targets novel mechanisms for a wide range of neuropsychiatric and neurodegenerative conditions, supported by a comprehensive set of tools for precision medicine. 

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