Imbrium Therapeutics has announced the submission of an investigational new drug application (IND) to the US Food and Drug Administration for a Phase II clinical trial of sunobinop to potentially treat moderate to severe alcohol use disorder (AUD).
The trial will be a randomised, double-blind, two-part, parallel-group, placebo-controlled study involving 240 subjects seeking treatment for AUD.
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It will assess the effect of sunobinop administered at bedtime on alcohol consumption, as well as alcohol craving.
Sunobinop, an investigational oral compound, has been developed to target the nociceptin/orphanin-FQ peptide receptor, which is said to play a significant role in various biological functions.
The compound is currently in clinical development not only for AUD but also for overactive bladder syndrome and interstitial cystitis/bladder pain syndrome.
The decision to move forward with the IND submission for sunobinop is backed by data indicating the efficacy of NOP agonists in treating AUD.
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By GlobalDataPreclinical studies have demonstrated that NOP activation can diminish the reinforcing effects of ethanol, which could be pivotal in managing AUD. Furthermore, NOP activity has been correlated with relapse risk in individuals with AUD.
The National Institute of Drug Abuse has recognised NOP receptor agonists as the top ten pharmacological mechanisms for the expedited development of substance use disorder treatments.
Additionally, sunobinop has shown promise in improving various sleep measurements, which could benefit individuals with AUD.
Imbrium Therapeutics chief scientific officer and vice-president Dr Julie Ducharme said: “Over the past several years, the data collected to date in our sunobinop development programme has supported this potent, partial and selective agonist³ as a potential treatment approach for AUD and other serious conditions.”
