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Ergomed’s insomnia drug meets primary endpoint in phase 2 trial

PBR Staff Writer Published 07 February 2017

A phase 2 clinical study evaluating Ergomed's Lorediplon met the primary endpoint with high statistical significance, indicating the drug has strong efficacy in sleep maintainance.

The phase 2 trial featured 145 adult patients with insomnia disorder where both 5 and 10mg strengths of the hypnotic drug met the primary endpoint while resulting in statistically important improvement.  

The drug demonstrated strong efficacy in sleep maintenance all through the night in comparison to placebo in the double-blind, dose-finding 4-way cross-over trial held at 11 European sleep labs.

Ergomed CEO Miroslav Reljanovic said: “The study also suggests that Lorediplon may have the potential to improve sleep maintenance for patients over current treatments and leave them feeling refreshed and alert upon awakening.

“Importantly, these positive results also endorse Ergomed’s co development business model.”

As per the trial findings, Lorediplon was well tolerated with an acceptable safety profile that also featured evaluation of residual effects in the next day. Treatment using the drug sustained natural sleep architecture as per the results.

Besides, important secondary endpoints such as improvements in Wake After Sleep Onset (WASO) in the second half of the night relative to zolpidem were also met.

Lorediplon is a non-BZD (benzodiazepine) hypnotic drug that modulates the gamma-Amino Butyric Acid A (GABAa) receptor. It is being jointly developed by the UK based pharmaceutical services and drug development firm jointly with Spanish pharma Ferrer.

Ferrer chief scientific officer Fernando Garcia Alonso said: “Lorediplon has proven to be efficacious in maintaining sleep throughout the night and the trends observed relative to zolpidem are very encouraging. Further analysis of the data is ongoing and based on the final results, we will seek to advance the product towards the market through additional partnerships.”

As per the terms of the joint development partnership, Ergomed is entitled to a portion of the revenue generated from Lorediplon’s commercialization.


Image: Ergomed’s insomnia drug Lorediplon registered positive top-line results in phase 2 trial. Photo: courtesy of jk1991/FreeDigitalPhotos.net.