Ferrer links with Ildong and Ergomed for lorediplon development

Privately-held Spanish drugmaker Ferrer has executed two agreements, one with South Korea’s Ildong Pharmaceuticals and the other with Ergomed Clinical Research of the UK to support further clinical studies of lorediplon in patients with insomnia.

Under the terms of the Ildong accord, Ferrer will be eligible to receive payments from the cooperation and license agreement covering countries within East Asia, including South Korea, China and Japan. Ildong will be responsible for the costs and activities related to development and regulatory approvals in their territory.

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 deal, 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.

First Ferrer CNS product to enter clinical trial

“Insomnia remains a common sleep disorder that has both a significant impact on an individual’s quality of life and a broader impact on society, in terms of reduced productivity and associated healthcare costs,” said Fernando Garcia Alonso, chief scientific officer at Ferrer, adding: “Lorediplon is the first product to enter clinical trials from our CNS discovery program, the aim of which is to deliver differentiated products targeting underserved needs in insomnia and related sleep disorders.”

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 (5mg and 10mg) 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 around 130 patients at 12 centers in three countries.

Lorediplon is a novel, longer acting non-benzodiazepine (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.