Neurim Pharma's piromelatine insomnia drug candidate does well in Ph II

Israel-based Neurim Pharmaceuticals has announced positive results from a Phase II study evaluating the efficacy and safety of piromelatine (Neu-P11), a novel investigational multimodal sleep medicine developed for the treatment of patients with primary and co-morbid insomnia.

The new results are from a recent double-blind, randomized, placebo controlled, parallel group, non-confirmatory, sleep-laboratory study. The study evaluated piromelatine compared to placebo in 120 adult primary insomnia patients aged 18 years and older.

Piromelatine 20/50mg treatment for four weeks resulted in statistically significant and clinically meaningful improvements relative to placebo in key polysomnographic (PSG) parameters including Wake After Sleep Onset (WASO) (p=0.02 for both doses) and in particular WASO for the first six hours of sleep (WASO-6h) (p=0.0008 and p=0.04 for the 50 mg and 20 mg groups, respectively). Piromelatine 50mg also improved Sleep Efficiency (SEF) (p=0.02), Total Sleep Time (TST) (p=0.02), Total Time Awake (TTA) (p=0.01) and time in NREM sleep (p=0.028) indicating beneficial effects on sleep maintenance.