Imbrium Therapeutics Completes First Patient Dosed in Phase 2 Study to Evaluate Sunobinop for the Potential Treatment of Alcohol Use Disorder

STAMFORD, Conn.--(BUSINESS WIRE)--Imbrium Therapeutics L.P. (“Imbrium”), a subsidiary of Purdue Pharma L.P. (“Purdue”), today announced the first patient has been randomized and dosed in a Phase 2 clinical study evaluating 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 designed to bind to and activate the nociceptin/orphanin-FQ peptide receptor (NOP), a protein that is widely expressed in the central and peripheral nervous system and involved in a range of biological functions.¹

“The National Institute on Alcohol Abuse and Alcoholism includes in its strategic plan the development of new medications to treat AUD,² while The National Institute on Drug Abuse has highlighted the potential use of NOP receptor agonists to treat substance use disorders,^3,4” said Craig Landau, MD, President and CEO, Purdue Pharma. “The sunobinop trial is an important part of our work to improve public health, and we look forward to learning more as we continue investigational efforts exploring sunobinop as a possible option to help individuals living with alcohol use disorder.”

Preclinical studies have shown activation of NOP in AUD models reduces the reinforcing and motivating effects of ethanol (alcohol).^5,6 In humans, lower NOP activity in the brain (measured by PET imaging) has been associated with an increased risk of relapse in 22 recently abstinent patients with severe AUD who were followed for 12 weeks.⁷

This randomized, double-blind, placebo-controlled study will seek to evaluate the effect of sunobinop on approximately 240 adult participants with moderate or severe AUD who are seeking treatment. Participants will receive either an oral dose of sunobinop or placebo to be taken at bedtime for 8 weeks, and their alcohol consumption will recorded/compared.

In addition to studying sunobinop as a potential treatment option for AUD, Imbrium is also evaluating sunobinop for potential treatment of overactive bladder syndrome and interstitial cystitis/bladder pain syndrome.

*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.

About Imbrium Therapeutics L.P.

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 we seek to actively collaborate with industry and academic partners to identify and advance future impactful medicines. For more information, please visit www.imbriumthera.com.

References

1. Lambert D. The nociceptin/orphanin FQ receptor: a target with broad therapeutic potential. Nat Rev Drug Discov. 2008;7:694–710.
2. NIAAA. Strategic Plan: Fiscal Years 2024-2028, Goal 4: Improve Diagnosis and Expand Treatment of Alcohol Use Disorder and Alcohol-Related Conditions. National Institute of Alcohol Abuse and Alcoholism. Accessed October 29, 2024. https://www.niaaa.nih.gov/about-niaaa/strategic-plan-fiscal-years-2024-2028/research-goals/goal-4-improve-diagnosis-and-expand-treatment-alcohol-use-disorder-and-alcohol-related
3. Rasmussen K, White DA, Acri JB. NIDA’s medication development priorities in response to the Opioid Crisis: ten most wanted. Neuropsychopharmacology. 2019; 44: 657-659.
4. Heidbreder C. Potential new Pharmacologic Developments for Opioid and Stimulant Use Disorders. National Institutes of Health HEAL Initiative. April 14, 2021. Accessed October 28, 2024. https://heal.nih.gov/files/2021-07/pharmacotherapeutic-opioid-stimulant-heidbreder.pdf
5. Ciccocioppo R, Panocka I, Polidori C, Regoli D, Massi M. Effect of nociceptin on alcohol intake in alcohol-preferring rats. Psychopharmacology. 1999;141(2):220-4.
6. Kuzmin A, Sandin J, Terenius L, Ogren SO. Acquisition, expression, and reinstatement of ethanol-induced conditioned place preference in mice: effects of opioid receptor-like 1 receptor agonists and naloxone. J Pharmacol Exp Ther. 2003;304(1):310-8.
7. Tollefson S, Stoughton C, Himes ML, et al. Imaging nociceptin opioid peptide receptors in alcohol use disorder with [11C]NOP-1A and positron emission tomography: Findings from a second cohort. Biol Psychiatry. 2023;94(5):416-423.

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