Sleep Disturbances and Recovering From Alcohol Use Disorder: Garth T. Whiteside, PhD


The head of preclinical development at Imbrium Therapeutics provided an overview of positive safe and efficacy findings from the phase 2 study investigating sunobinop. [WATCH TIME: 4 minutes]

WATCH TIME: 4 minutes

“In addition to the sleep effects and the association between sleep disruption, and alcohol, there's also a body of literature with a strong link between this receptor [ ] and the reinforcing effects of alcohol.”

Sunobinop, an oral compound, is in evaluation as a potential treatment for multiple disorders including insomnia for patients in recovery from alcohol use disorder (AUD). The treatment is designed to bind to and activate the nociceptin/orphanin-FQ peptide receptor and is also in a range of functions biologically including stress response, anxiety modulation, and substance misuse.1,2

In December 2022, Imbrium Therapeutics revealed safety and efficacy results from a phase 2 study (NCT04035200) on its investigational treatment, sunobinop (V117957), for patients with insomnia in recovery from AUD.3 The trial enrolled 114 patients with insomnia in recovery from AUD who were randomized to receive sunobinop 1 mg or 2 mg or placebo every night for 21 days. Change from baseline on wakefulness after sleep onset (WASO) was the primary endpoint, measured by 2 consecutive nights of overnight polysomnography.

Both doses of sunobinop met primary endpoint with significant reductions in WASO in comparison with placebo. On nights 1 and2, the least squares mean (LSM) difference between sunobinop 1 mg and placebo was −12.03 minutes (95% CI, −22.1 to −1.9; P = .050), and the LSM difference between sunobinop 2 mg and placebo was −18.35 minutes (95% CI, −28.5, −8.2; P = 0.003). On nights 20 and21, the LSM difference between sunobinop 1 mg and placebo was −12.35 minutes (CI, −24.7 to 0.0; P=0.099), and the LSM difference between sunobinop 2 mg and placebo was −15.80 minutes (CI, −28.6, −3.0; P=0.043).

Garth Whiteside, head of preclinical development at Imbrium Therapeutics, sat down with NeurologyLive® in an interview to discuss the investigational use of sunobinop with insomnia in patients recovering from alcohol use disorder. He mentioned the literature surrounding the associations between poor sleep and drinking outcomes, as well as highlighted the main findings from the trial and how the results were measured, particularly the primary outcome.

1. Zaveri NT. Nociceptin Opioid Receptor (NOP) as a Therapeutic Target: Progress in Translation from Preclinical Research to Clinical Utility. J Med Chem. 2016;59(15):7011-7028. doi:10.1021/acs.jmedchem.5b01499
2. Lambert DG. The nociceptin/orphanin FQ receptor: a target with broad therapeutic potential. Nat Rev Drug Discov. 2008;7(8):694-710. doi:10.1038/nrd2572
3. Imbrium Therapeutics Presents Results of a Phase 2 Study of Sunobinop at 33rd American Academy of Addiction Psychiatry Annual Meeting. News Release. Imbrium Therapeutics. Published December 12, 2023. Accessed February 10, 2023.
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