Clinical evaluation of opioid use disorder treatment funded by $5.6M NIH grant
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Biopharmaceutical company Aptinyx Inc. announced the finalization of a $5.6 million NIH grant for the development of a novel therapeutic for the treatment of opioid use disorder.
According to a release from Aptinyx, the grant will arrive through the Helping to End Addiction Long-term (HEAL) Initiative and administered by NIDA supporting the development of NYX-783, an NMDA receptor positive allosteric modulator also in phase 2b development for the treatment of PTSD.
The research and development of NYX-783 will be handled by researchers at Yale University School of Medicine, who expect to commence a phase 1 clinical study of NYX-783 later this year.
“We are excited to be partnering with world-class researchers at Yale in this evaluation of NYX-783, funded by a prestigious and generous grant from NIDA through the NIH HEAL Initiative,” Andy Kidd, MD, president and CEO at Aptinyx, stated in the release. “We look forward to collaborating with our research partners at Yale on the initiation of a phase 1 clinical study of NYX-783 in people who use opioids. The NIDA grant, secured by the experienced researchers at Yale, ensures this development program can be advanced in a manner that is capital efficient for Aptinyx.”
The co-principal investigators for the evaluation of NYX-783 in OUD are Ralph DiLeone, PhD, professor of psychiatry and of neuroscience at Yale University School of Medicine, and Rajita Sinha, PhD, professor of psychiatry and of neuroscience and child study at Yale University School of Medicine.
Per the release, the pending phase 1 study will be a randomized, double-blind, placebo-controlled trial which will assess the safety, tolerability and pharmacokinetics of NYX-783 in 50 mg and 150 mg doses, combined with 15 mg and 30 mg doses of oxycodone in individuals who use opioids.
The primary outcome measures in the study will evaluate a variety of safety-related measures, including change in respiratory rate, oxygenation saturation, blood pressure, heart rate, and cardiac activity over three weeks. Secondary outcome measures will evaluate opiate withdrawal and symptom scales over three weeks, the release said.
The study will be conducted at the Yale Interdisciplinary Stress Center through a research collaboration with Aptinyx.
“We are pleased to continue our collaboration with Aptinyx for the evaluation of NYX-783 for the treatment of OUD,” DiLeone said in the release. “With the support of the NIDA grant, we look forward to translating these findings to clinical benefit in humans through this phase 1 development program.”