Insomnia associated with alcohol cessation (IAAC) is a major challenge faced by patients who are recovering from AUD (alcohol use disorder), struggling to achieve sustained abstinence from alcohol. Given the massive opportunity, global pharmaceutical firms are increasingly working towards development of a drug to treat this disorder.

A major contribution to this is being done by Imbrium Therapeutics, a clinical stage biopharmaceutical firm dedicated towards finding therapies to treat issues related to the human central nervous system, reportedly announced the dosing of first patient in its Phase 2 clinical trial (OAG2002) of the firm’s new, innovative small molecule IMB-115, designed for the treatment of IAAC (insomnia associated with alcohol cessation).

The double-blind, multi-center, placebo-controlled, randomized, parallel-group trial evaluates the compound’s tolerability, safety and efficacy in adults with severe or moderate AUD (alcohol use disorder) who are suffering from IAAC. IMB-115 is a compound discovered internally, having a new action mechanism in clinical development to treat disorders relating to insomnia which also include IAAC.

Chief Medical Officer at Research Centers of America as well as principal investigator for the OAG2002 trial, Howard Schwartz, MD stated that among individuals that are recovering from AUD, insomnia is an important concern since it is persistent, common and is also associated with relapse.

Schwartz added that first patient dosed in the Phase 2 trial of IMB-115 signifies an important milestone as the company advances its understanding of the IMB-115’s potential therapeutic application in IAAC.

In the Phase 2 trial, subjects would receive IMB-115 (2 mg or 1 mg) or placebo, dosed orally during bedtime for the duration of three weeks. The primary outcome measure of the trial is change from the baseline of WASO (wakefulness after sleep onset), as measured by PSG (polysomnography).

Secondary result measures include baseline changes that are related to sleep latency, efficiency, number of awakenings and total sleep time. The interventional trial is projected to be completed late in 2020.

Results from Phase 1 trial of IMB-115, conducted to treat insomnia disorder, found growth in sleep efficiency over placebo, as well as decrease of sleep fragmentation across the night.

Furthermore, Imbrium is also evaluating the probable utility of molecule IMB-115 in the treatment of neurological and psychiatric disorders.

Source credit: https://www.imbriumthera.com/news/imbrium-therapeutics-announces-first-patient-dosed-in-phase-2-study-of-potential-first-in-class-molecule-for-insomnia-associated-with-alcohol-cessation/