Imbrium Therapeutics L.P. (“Imbrium”), a subsidiary of Purdue Pharma L.P. (“Purdue”), has submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) to evaluate sunobinop for the potential treatment of moderate to severe alcohol use disorder (AUD). Sunobinop is an investigational, novel, and potential first-in-class oral compound discovered by Imbrium’s scientists that is currently in clinical development. It is designed to bind to and activate the nociceptin/orphanin-FQ peptide receptor (NOP), a protein widely expressed in the central and peripheral nervous system and involved in a range of biological functions.
“Over the past several years, the data collected in our sunobinop development program has supported this potent, partial, and selective agonist as a potential treatment approach for AUD and other serious conditions,” said Dr. Julie Ducharme, Vice President and Chief Scientific Officer.
“As part of our ongoing commitment to improving public health as an R&D-driven pharmaceutical company, we look forward to learning more about sunobinop and the role of NOP receptors in AUD,” said Craig Landau, MD, President and CEO of Purdue.
Sunobinop Development Program
Imbrium is evaluating sunobinop as a potential treatment option for AUD, as well as for overactive bladder syndrome (OAB) and interstitial cystitis/bladder pain syndrome (IC/BPS). This IND submission is informed by data suggesting that NOP agonists, like sunobinop, have potential for the treatment of AUD.
Preclinical studies have shown that activation of NOP in AUD models reduces the reinforcing and motivating effects of ethanol (alcohol). In humans, NOP activity has been associated with relapse risk in patients with AUD.
The National Institute of Drug Abuse has identified NOP receptor agonists among the ten most wanted pharmacological mechanisms for rapid development of therapeutics to treat substance use disorder.
Sunobinop studies have suggested improvements in various sleep measurements. Building on these data, Imbrium intends to conduct a two-part, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the impact of sunobinop given at bedtime on alcohol consumption and alcohol craving. This Phase 2 study will recruit 240 subjects with moderate to severe AUD who are seeking treatment.
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that sunobinop will successfully complete development or gain FDA approval.
Imbrium is a clinical-stage biopharmaceutical company dedicated to advancing medical science through the development of important new therapeutics. We are pursuing treatments for genitourinary disorders, disorders of the central nervous system, oncology chemotherapeutics, and non-opioid approaches to the management of pain. As a subsidiary of Purdue Pharma L.P., Imbrium strives to develop new medicines that serve the unmet needs of patients, physicians, and health systems worldwide. We have built a robust and diversified pipeline of investigational drug candidates and seek to actively collaborate with industry and academic partners to identify and advance future impactful medicines. For more information, please visit www.imbriumthera.com.
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