Ergomed reports positive results from insomnia drug trial

AIM-listed pharma company Ergomed on Monday reported positive top-line results from a Phase II clinical trial of Lorediplon in patients with insomnia with its co-development partner Ferrer.

The company said both 5 and 10mg Lorediplon met the primary endpoint with “high statistical significance”, indicating the drug has strong efficacy in sleep maintainance throughout the night when compared to the placebo.

Lorediplon was well tolerated with an acceptable safety profile including on assessment of next day residual effects and the treatment preserved natural sleep architecture, Ergomed said.

The double-blind, dose-finding four-way cross-over study was performed in 11 sleep labs in Europe. All 145 patients sequentially received, in a random order, Lorediplon 5 and 10 mg, zolpidem 10mg (typical commercial dose) and placebo to characterise its efficacy, safety and tolerability profile and to evaluate any next day residual effects in adult patients with insomnia disorder.

“Both Lorediplon doses were shown to be well tolerated with an overall low incidence of treatment-related adverse events. As expected, for a drug of this class, the most frequently reported treatment related adverse events were dizziness, somnolence, headache, fatigue, hangover and nausea,” Ergomed said.

Under the terms of the co-development partnership with Ferrer, Ergomed will receive a share of the revenue received from the commercialisation of the drug.