Date: 2014-02-03
Type of information:
Compound: lorediplon
Company: Ferrer (Spain) Ergomed Clinical Research (UK)
Therapeutic area:
Type agreement: development
Action mechanism: Lorediplon is a novel, longer acting non-BZD hypnotic drug that modulates the GABAa receptor. Compared to other non-BZD receptor agonists (such as zolpidem), Lorediplon has demonstrated in preclinical and clinical studies a potent hypnotic profile and extended systemic half-life, properties that could confer potential clinical benefits in terms of sleep maintenance and sleep architecture. A recent Phase I pharmacodynamic study with Lorediplon (in a phase advanced model of insomnia) demonstrated the orally available compound has a best-in-class efficacy profile in terms of sleep maintenance and sleep quality when compared to market leader zolpidem. In this model Lorediplon demonstrated dose related clinical benefits in measured sleep parameters that were either comparable to or exceeded zolpidem in terms of the duration and quality of sleep that subjects achieved.
Disease: insomnia
Details: * On February 3, 2014, Ferrer, a privately-held Spanish pharmaceutical company, has announced that it has executed an agreements with Ergomed Clinical Research Ltd, UK to support further clinical studies of Lorediplon in patients with insomnia. Ferrer selected Ergomed as the clinical development organization to conduct the multicenter, multinational, randomized Phase IIa lorediplon trial in insomnia. Under the terms of the agreement, Ergomed will assume a proportion of the clinical and regulatory costs of the Phase IIa trial in return for a share of future revenues received by Ferrer for lorediplon in this indication.The trial is a double-blind, randomized, placebo-controlled cross-over, dose finding study of two doses of Lorediplon in adult patients with primary insomnia. The effects of Lorediplon (5 and 10 mg) will be compared to a placebo and to zolpidem. The aim of the study is to evaluate the appropriate effective dose of lorediplon, to characterize the efficacy in sleep maintenance and sleep onset and to evaluate any next day hangover effect in adult patients with primary insomnia. The trial is anticipated to be initiated in the second quarter of 2014. It will involve approximately 130 patients at 12 centres in three countries.
Financial terms:
Latest news:
