Purdue Pharma LP operating subsidiary Imbrium Therapeutics LP 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. 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 who are experiencing insomnia associated with alcohol cessation. IMB-115 is an internally discovered compound with a novel mechanism of action in clinical development for the treatment of insomnia disorders, including insomnia associated with alcohol cessation.
“Among individuals recovering from alcohol use disorder, insomnia is a significant concern because it is common, persistent, and associated with relapse,” says Howard Schwartz, MD, chief medical officer, Research Centers of America and principal investigator of the OAG2002 study, in a release. “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 3 weeks. The study’s primary outcome measure is change from baseline of wakefulness after sleep onset, as measured by polysomnography. 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,” says Paul Medeiros, president of 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,” says Craig Landau, MD, president and CEO, Purdue Pharma. “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 news brief 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.