Neumora Therapeutics Announces Initiation of Phase 1 Clinical Study of M4 Positive Allosteric Modulator NMRA-861

• NMRA-861 has potential best-in-class pharmacology, which may enable a more favorable therapeutic profile

• No convulsions observed in pre-clinical studies conducted in multiple species, including rabbits

  
  

WATERTOWN, Mass., July 09, 2025 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of seven brain disease programs including three clinical-stage programs, today announced the initiation of a Phase 1 single-ascending dose/multiple-ascending dose (SAD/MAD) study of NMRA-861 in healthy adult participants and adults with stable schizophrenia. NMRA-861 is a highly potent and selective positive allosteric modulator (PAM) of the M4 muscarinic receptor with potential best-in-class pharmacology that Neumora is developing for the treatment of schizophrenia and other neuropsychiatric disorders. Neumora expects to report data from the Phase 1 SAD/MAD study in the first quarter of 2026, including safety and tolerability, and human pharmacokinetic data confirming the potential for once-daily dosing and central nervous system penetration.

“NMRA-861 has potential as a differentiated treatment option across multiple indications and may offer an improved therapeutic profile relative to current antipsychotics and other non-selective muscarinic agonists,” said Nick Brandon, Ph.D., chief scientific officer, Neumora. “The initiation of the Phase 1 SAD/MAD study with NMRA-861 is an important step for our M4 franchise, and we look forward to reporting data from this study next year.”

NMRA-861 has demonstrated a potentially best-in-class pharmacological profile and robust activity in preclinical efficacy models. NMRA-861 was safe and well-tolerated in pre-clinical toxicology studies and no convulsions have been observed in rabbits, dogs and rats.

“Schizophrenia is a complex and serious disorder. Although antipsychotic agents are the cornerstone of treatment for schizophrenia, their effectiveness is limited, leaving many patients symptomatic despite ongoing antipsychotic therapy. Additionally, medication-related side effects and non-adherence remain key obstacles in treating patients,” said Dr. Christoph Correll, Clinical Professor of Psychiatry, Zucker School of Medicine at Hofstra/Northwell, NY, and Professor of Child and Adolescent Psychiatry, Charité University Medicine, Berlin, Germany. “Targeting M4 receptors is a highly promising approach to treating schizophrenia, and emerging evidence indicates that targeting the allosteric binding site allows for greater selectivity for the M4 receptor, which may lead to a more favorable therapeutic profile, including tolerability and once-daily dosing. The potential for M4 PAMs to modulate cholinergic and dopamine signaling without the side effects of traditional antipsychotics opens a compelling new chapter in the treatment of schizophrenia and other serious neuropsychiatric conditions. Expanding the range of treatment options for patients and clinicians is essential to addressing this critical unmet need.”

About NMRA-861


NMRA-861 is an investigational positive allosteric modulator of the M4 muscarinic receptor subtype. Neumora exclusively licensed certain intellectual property rights related to NMRA-861 from the Warren Center for Neuroscience Drug Discovery at Vanderbilt University, including a composition of matter patent extending to 2044 excluding any patent term adjustment or extension. While most current antipsychotics approved for schizophrenia work primarily by blocking D2 dopamine receptors, growing evidence supports the approach of targeting the M4 muscarinic receptor to elicit antipsychotic effects, without the side effects associated with the first- and second-generation antipsychotics. M4 muscarinic receptor-targeting compounds have shown robust antipsychotic activity in multiple, placebo-controlled clinical trials, demonstrating potential as an approach to treating schizophrenia. NMRA-861 has demonstrated a best-in-class pre-clinical profile in studies which were completed at the Warren Center for Neuroscience Drug Discovery at Vanderbilt University.