Potentially game-changing schizophrenia drug enters trials

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A potential schizophrenia treatment, discovered at Vanderbilt University in Tennessee in the US, has been cleared by the US Food and Drug Administration for use in Phase I clinical trials.

NMRA-266, an allosteric modulator that works through a mechanism that has been clinically validated in the treatment of disorders like schizophrenia, will be developed by Neumora Therapeutics.

It was discovered in the labs of Craig Lindsley, Director of the Warren Center for Neuroscience Drug Discovery (WCNDD) and Director Emeritus Jeffrey Conn.

“Vanderbilt is proud that a discovery by our researchers at the Warren Center is now a significant step closer to helping improve the lives of people with schizophrenia,” Chancellor Daniel Diermeier said. “Our work with Neumora is the very definition of translational research and the work we aim to do every day, which is applying innovation and discovery to help address the world’s most complex challenges.”

Vanderbilt and Neumora have signed an exclusive, worldwide license and a research collaboration agreement for two novel series of M4 receptor modulator compounds, including NMRA-266.

Highly selective to the M4 receptor

Vanderbilt’s agreement with Neumora was centred around the M4 muscarinic receptor, which NMRA-266 targets through positive allosteric modulation. In preclinical studies conducted by Conn and Lindsley, NMRA-266 was found to be highly selective to the M4 receptor, the area of the brain that regulates neurotransmission of dopamine. Overactive transmission of dopamine is connected to the positive, negative and cognitive symptoms of schizophrenia.

“This mechanism and NMRA-266 represent a potential game-changer for schizophrenic patients and their families. Moreover, this success is a testament to the virtue of academic drug discovery and Vanderbilt’s commitment to supporting the WCNDD, a clinical-stage biotech enterprise within the university,” said Lindsley, also a University Professor of pharmacology, biochemistry and chemistry who holds the William K Warren, Junior Chair in Medicine.

Dr Robert Lenz, Executive Vice President and Head of Research and Development at Neumora, added: “The initiation of this Phase I study is an important step in the development of NMRA-266. With its pre-clinical profile and clinical validation of the M4 muscarinic receptor class in treating schizophrenia, we believe that NMRA-266 has strong potential as a treatment for neuropsychiatric disorders.”

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