Imbrium Therapeutics L.P., a clinical-stage biopharmaceutical company and operating subsidiary of Purdue Pharma L.P., announced it is advancing its novel, potentially first-in-class small molecule IMB-115 (previously referred to as IT-1315) to a Phase 2 clinical study following favorable results from Phase 1 studies evaluating the molecule’s safety and tolerability, including its potential for abuse and interaction with alcohol. 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 (IAAC). This Phase 2 study evaluating proof-of-concept for the molecule in patients with IAAC has been initiated and will begin patient enrollment in July.
“Given the substantial medical need in insomnia associated with alcohol cessation, we believe that treatment of the disorder would benefit greatly from the availability of novel, differentiated treatment modalities,” said Paul Medeiros, president, Imbrium Therapeutics. “Results from the recent IMB-115 alcohol interaction and abuse potential safety studies, along with our earlier efficacy findings, suggest that continued advancement of this molecule is warranted. We look forward to continuing our research of IMB-115 in insomnia associated with alcohol cessation and across the spectrum of insomnia disorders.”
Findings from Phase 1 studies of IMB-115 for the treatment of insomnia disorder showed improvements over placebo in multiple sleep efficacy parameters, including reduction of sleep fragmentation throughout the night. Results from a Phase 1b dose-ranging study evaluating IMB-115 in patients with insomnia disorder were announced last year.
Study Evaluating the Abuse Potential of IMB-115
In accordance with the U.S. Food and Drug Administration’s (FDA) industry guidance on the Assessment of Abuse Potential of Drugs,1 Imbrium conducted a study specifically designed to assess the molecule’s potential for abuse, which showed that drug liking responses at anticipated therapeutic doses were comparable to placebo.
This randomized, single-dose, double-blind, crossover study was conducted to evaluate the pharmacokinetics, safety and abuse potential, of IMB-115 (1 mg, 6 mg, and 10 mg) as compared to triazolam (0.5 mg and 1 mg) and placebo in healthy, non-dependent, recreational sedative users (n=50). In the study, assay sensitivity was met, establishing study validity. Results indicated that drug liking of the compound at the therapeutic dose of 1 mg was not statistically different from placebo. Supratherapeutic doses of IMB-115 (6 mg and 10 mg) showed drug liking results and adverse events that were similar to the positive control (triazolam 0.5 mg and 1 mg), however no amnestic effects were noted with IMB-115.