Neurocrine will conduct a study to investigate a new treatment for schizophrenia
A Phase 2 clinical trial for the treatment of schizophrenia has been accepted by the US Food and Drug Administration (FDA) and a study can now move forward.
Neurocrine Biosciences received the news and informed its partner Sosei Group Corporation. Approval of the NBI-1117568 study triggered a $30 million payment to Sosei.
The drug is a selective oral muscarinic M4 receptor agonist in development for the treatment of schizophrenia and other neuropsychiatric disorders.
As a selective M4 orthosteric agonist, NBI-1117568 offers the potential to provide therapeutic effects without the need for combination therapy to minimize side effects, as required with non-selective muscarinic agonists.
At the same time, it avoids the requirement of cooperativity with acetylcholine (ACh) compared to positive allosteric modulators. Clinical studies to date have shown that NBI-1117568 is generally well tolerated.
Chris Cargill, President and CEO of Sosei Heptares, said, “We are excited about the progress of NBI-1117568 and our collaboration with Neurocrine in our portfolio of novel M4 and M1 selective agonists. Muscarinic receptors are important drug targets in psychosis and cognitive impairment and through the application of our StaR technology platform and our expertise in structure-based drug design focused on GPCRs, we have discovered selective agonists of M4 and M1.
“These new drug candidates have been designed to provide enhanced therapeutic effects while avoiding unwanted M2 and M3 activation and its associated side effects. Our selective approach to muscarinic agonists is supported by significant scientific and clinical evidence supporting its potential to address key unmet needs in neurological and psychiatric disease and we are excited to advance developments in this area with Neurocrine.
NBI-1117568 is the lead candidate of a broad portfolio of clinical and preclinical subtype-selective muscarinic M4, M1 and dual M1/M4 receptor agonists discovered by Sosei Heptares and in development as part of the 2021 collaboration with Neurocrine for the treatment of major neurological disorders.
After the success of the preclinical studies, the American company Neurocrine plans to launch phase 1 studies for a dual M1/M4 and a selective M1 agonist. Advancement of additional compounds into clinical studies would trigger further milestone payments from Neurocrine to Japanese company Sosei Heptares.
Eiry Roberts, Chief Medical Officer of Neurocrine, said: “We are delighted to advance the lead asset of our strategic collaboration, NBI-1117568, into a Phase 2 study for the treatment of schizophrenia this year and look forward to to continue our partnership with the Sosei Heptares team.