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
Excerpt from the Press Release:
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.
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