Ergomed completes patient recruitment for insomnia drug trial

The company is developing the drug with Spanish pharmaceutical firm Ferrer. It has now recruited 130 patients from 11 clinical sites across three European countries.

The trial, which is expected to finish in the fourth quarter of this year, will be a double-blind, randomized, placebo-controlled cross-over, dose finding study of two oral doses of lorediplon.

The effects of lorediplon (5 and 10 mg) will be compared to both placebo and zolpidem.

Ergomed CEO Miroslav Reljanovic said the completion of patient recruitment marked another important step in the drug's clinical development.

"Lorediplon previously demonstrated – in a phase advanced model of insomnia – a potential best-in-class efficacy profile in terms of sleep maintenance and sleep quality when compared to the market leader zolpidem.

"This would make a marked improvement in the lives of patients suffering from this disorder."

Lorediplon is a novel, longer acting non-BZD (benzodiazepine) hypnotic drug that modulates the GABAa receptor.

Compared to other non-BZD receptor agonists in preclinical and clinical studies, lorediplon showed a potent hypnotic profile and extended systemic half-life; properties that may confer possible clinical benefits with respect to sleep maintenance and sleep architecture.

In a phase 1 pharmacodynamic study, lorediplon was safe and well tolerated. There were no residual effects observed up to fourteen hours after dosing.

Image: Ergomed completes recruitment in a phase IIa clinical trial of lorediplon in patients with insomnia disorder. Photo: courtesy of jk1991 at FreeDigitalPhotos.net.