Neurim Pharmaceuticals has announced positive results from a phase II clinical study reviewing the efficacy and safety of piromelatine.
The novel investigational multimodal sleep medicine has been developed for the treatment of patients with primary and co-morbid insomnia, with the results coming from a laboratory study.
It looked at piromelatine compared to placebo in 120 adult primary insomnia patients aged 18 and older.
A 20/50mg treatment of the drug for four weeks led to substantial and clinically meaningful improvements that were related to placebo in key polysommographic parameters.
Piromelatine enhanced NREM sleep EEG delta power and reduced beta power markedly.
The decrease in EEG beta activity is a physiological surrogate marker of the efficacy of piromelatine in sleep maintenance.
The drug was safe, well tolerated and had no adverse effects on next-day psychomotor performance for any dose group, along with no deleterious impacts on sleep structure and architecture.
Piromelatine works with a combination of MT1/MT2 and 5HT1A/D, and all potential effects of the drug were shown in relevant animal models.
Phase-1A and 2B analysis of the safety, tolerability, pharmacokinetics and sleep promoting activity of the drug showed good absorption, distribution, safety and tolerability.
Professsor Nava Zisapel from Neurim said: "Piromelatine demonstrates a good potential for the treatment of primary insomnia characterized by sleep maintenance disturbances as well as insomnia with psychiatric or medical co-morbiditie."
Neurim has also investigated the effects of its Circadin drug, which also aims to treat insomnia.
It analysed the drug alongside Zolpidem on placebo on postural stability in middle aged volunteers.
Postural instability, which is also described as body sway, is regarded as an important risk factor for falls and fracture among hypnotic drugs users.
However, no significant differences were found between Circadin and placebo in body sway as measured by the A95 parameter, except small differences at four hours.
