Imbrium Therapeutics Announces First Patient Dosed in Phase 2 Study of Potential First-in-Class Molecule for Insomnia Associated with Alcohol Cessation

STAMFORD, Conn.–(BUSINESS WIRE)–Imbrium Therapeutics L.P., a clinical-stage biopharmaceutical company and operating subsidiary of Purdue Pharma L.P., today announced the first dose administered in the Phase 2 clinical study (OAG2002) of its novel, potentially first-in-class small molecule IMB-115 for the treatment of insomnia associated with alcohol cessation (IAAC). The randomized, double-blind, placebo-controlled, multi-center, parallel-group study evaluates the compound’s safety, efficacy, and tolerability in adults with moderate or severe alcohol use disorder (AUD) who are experiencing IAAC. IMB-115 is an internally discovered compound with a novel mechanism of action in clinical development for the treatment of insomnia disorders, including IAAC.

“Among individuals recovering from alcohol use disorder, insomnia is a significant concern because it is common, persistent, and associated with relapse,”¹ said Howard Schwartz, MD, chief medical officer, Research Centers of America and principal investigator of the OAG2002 study. “Dosing of the first patient in the Phase 2 study of IMB-115 represents an important milestone as we advance our understanding of this molecule’s potential therapeutic application in insomnia associated with alcohol cessation.”

In the Phase 2 study, subjects will receive IMB-115 (1 mg or 2 mg) or placebo, administered orally at bedtime for three weeks. The study’s primary outcome measure is change from baseline of wakefulness after sleep onset (WASO), as measured by polysomnography (PSG). Secondary outcome measures include changes from baseline related to sleep efficiency, latency, total sleep time, and number of awakenings. The interventional study is estimated to be completed in late 2020.

“Insomnia is a major challenge for many individuals recovering from alcohol use disorder, which affects approximately half of people experiencing alcohol withdrawal. However, there are no FDA-approved pharmacological treatment options to help these individuals address this potential obstacle to lasting recovery,” said Paul Medeiros, president, Imbrium Therapeutics. “Given the substantial medical need in insomnia associated with alcohol cessation, we are pleased to advance our research of IMB-115 and look forward to further exploring its potential therapeutic application across the spectrum of insomnia disorders.”

Findings from Phase 1 studies of IMB-115 for the treatment of insomnia disorder showed increases in sleep efficiency over placebo, and reduction of sleep fragmentation throughout the night. Additional previously announced studies of IMB-115 showed drug liking responses at anticipated therapeutic doses that were comparable to placebo; no significant changes in pharmacokinetic parameters resulting from co-administration with alcohol; and no changes in clinical laboratory values, vital signs, or oxygen saturation levels at anticipated therapeutic doses. IMB-115 is minimally metabolized by the liver, increasing its suitability for use in patients with a history of significant alcohol use who are more likely to have impaired liver function.

“Untreated insomnia in people recovering from alcohol use disorder has been shown to interfere with recovery, and can be challenging for patients who are striving to maintain their sobriety,” said Craig Landau, MD, president and CEO, Purdue Pharma L.P. “Our pursuit of new medicines is driven by our commitment to innovation and our recognition of important unmet needs in certain patient populations. With the administration of the first dose in this clinical trial, we move closer to our goal of addressing an important unmet medical need for people experiencing insomnia associated with alcohol cessation, and hope it may help them during their road to recovery.”

Imbrium is further evaluating the possible utility of IMB-115 in the treatment of additional psychiatric and neurological disorders.

This release discusses an investigational new drug under development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational drug will successfully complete clinical development or receive regulatory approval.

About Insomnia Associated with Alcohol Cessation

Insomnia is a common sleep disorder, characterized by difficulty falling asleep, staying asleep, or waking up too early, even when there is sufficient opportunity to sleep through the night.^2,3 Insomnia associated with alcohol cessation is a major challenge facing some patients recovering from alcohol use disorder in their struggle to sustain abstinence from alcohol use.⁵ Previous studies of patients with alcohol use disorder have found untreated insomnia may interfere with recovery from the alcohol addiction and contribute to relapse during recovery.⁴ Insomnia may result in daytime fatigue and is also associated with cardiovascular, neurological, and mental health conditions, among others.^5,6,7

About Imbrium Therapeutics L.P.

Imbrium is a clinical-stage biopharmaceutical company dedicated to advancing medical science through the development of important new pharmacologic and biologic therapeutics. We are pursuing treatments for disorders of the central nervous system, oncology chemotherapeutics, and non-opioid approaches to the management of pain. As an operating subsidiary of Purdue Pharma L.P., Imbrium strives to develop and bring to market 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 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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¹ Brower KJ, Perron BE. Prevalence and correlates of withdrawal-related insomnia among adults with alcohol dependence: Results from a national survey. Am J Addict. 2010;19(3):238–244. Accessed Jun 20, 2019. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2998536/pdf/nihms185938.pdf.

² American Psychiatric Association. Insomnia. In Diagnostic and Statistical Manual of Mental Disorders (5th ed.). Arlington, VA: American Psychiatric Publishing; 2013.

³ American Academy of Sleep Medicine. Insomnia Fact Sheet. Accessed May 22, 2019. Retrieved from https://aasm.org/resources/factsheets/insomnia.pdf.

⁴ Arnedt JT, Conroy DA, Brower KJ. Treatment options for sleep disturbances during alcohol recovery. J Addict Dis. 2007; 26(4):41-54.

⁵ Levenson JC, Kay DB, Buysse DJ. The pathophysiology of insomnia. Chest. 2015;147(4):1179-1192.

⁶ Institute of Medicine. Sleep disorders and sleep deprivation: An unmet public health problem. Washington, DC: National Academies Press. 2006.

⁷ Pase MP, Himali JJ, Grima NA, et al. Sleep architecture and the risk of incident dementia in the community. Neurology. 2017;89(12):1244-1250.

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