Imbrium Therapeutics Files IND for Sunobinop to Treat Alcohol Use Disorder

STAMFORD, CT, USA I August 05, 2024 I Imbrium Therapeutics L.P., a subsidiary of Purdue Pharma L.P., has filed an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) to assess the efficacy of sunobinop for treating moderate to severe alcohol use disorder (AUD).

Sunobinop is an innovative and potentially first-in-class oral compound currently undergoing clinical trials. It was discovered by Imbrium's scientists and targets the nociceptin/orphanin-FQ peptide receptor (NOP), a protein prevalent in both the central and peripheral nervous systems. This receptor plays a crucial role in various biological functions.

Dr. Julie Ducharme, Vice President and Chief Scientific Officer, mentions that several years of data collection have highlighted sunobinop as a promising treatment for AUD and other serious conditions. Dr. Craig Landau, President and CEO of Purdue, emphasized the company's commitment to public health and its eagerness to explore the potential of sunobinop and the NOP receptors in combatting AUD.

The development program for sunobinop is extensive, as it is being evaluated not just for AUD but also for overactive bladder syndrome (OAB) and interstitial cystitis/bladder pain syndrome (IC/BPS). The current IND submission is based on data indicating that NOP agonists, such as sunobinop, may be effective in treating AUD. Preclinical studies have shown that activating the NOP receptor in AUD models can reduce the reinforcing and motivational effects of alcohol. Moreover, in humans, NOP receptor activity has been linked to the risk of relapse in AUD patients. The National Institute of Drug Abuse (NIDA) has recognized NOP receptor agonists as one of the top ten pharmacological mechanisms needing rapid development for treating substance use disorders.

Building on promising data, Imbrium plans to conduct a two-part, randomized, double-blind, placebo-controlled, parallel-group study. This Phase 2 study will investigate the impact of administering sunobinop at bedtime on alcohol consumption and cravings. The study will recruit 240 subjects with moderate to severe AUD who are seeking treatment.

About Imbrium Therapeutics L.P.

Imbrium Therapeutics is a clinical-stage biopharmaceutical company focused on advancing medical science through the development of new therapeutics. The company is dedicated to finding treatments for genitourinary disorders, central nervous system disorders, oncology chemotherapeutics, and non-opioid pain management. As a subsidiary of Purdue Pharma L.P., Imbrium aims to develop medications that address the unmet needs of patients, physicians, and health systems globally. The company maintains a robust and diverse pipeline of investigational drug candidates and actively seeks collaboration with industry and academic partners for future medicines.

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