Drug trials specialist Ergomed Plc (LON:ERGO) has announced positive top-line results from a Phase II clinical trial of a treatment for insomnia with its co-development partner Ferrer.
The group said both 5mg and 10mg of the drug Lorediplon met the primary endpoint with high statistical significance, indicating the drug has “strong efficacy in sleep maintainance throughout the night when compared to placebo.”
It added that Lorediplon was well tolerated with an acceptable safety profile including on assessment of next day residual effects
Ergomed said key secondary endpoints were also met in the double-blind, dose-finding four-way cross-over study, performed in 11 sleep labs in Europe.
Dr. Miroslav Reljanovic, Ergomed’s chief executive officer of Ergomed, said: "We are delighted by the positive Phase II data for Lorediplon which we believe has the potential to be a significant treatment for insomnia.
“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.”
Business model endorsed ...
He added: “Importantly, these positive results also endorse Ergomed's co development business model. As demonstrated here, our experience and expertise of running clinical trials over the last 20 years can be effectively leveraged into progressing commercially attractive assets. We are confident that the sharing of such risk and reward will subsequently translate into significant additional value to our shareholders."
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.
Fernando Garcia Alonso, chief scientific officer at Ferrer said: "We are very pleased that this study, conducted by Ergomed, has been successful.”
He added: “ 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."
Broker upbeat ...
In a note to clients, ‘house’ broker Stifel said the data “moves Lorediplon well up the rankings in the global insomnia pipeline in our view (e.g. ahead of Actelion's DORA)”.
As a result, the broker has increased the probability of Lorediplon reaching Phase 3 to two-thirds, raised its overall probability of approval to 33%, and hiked its valuation for Ergomed to 277p a share.
In midday trading, Ergomed shares were up almost 1.7%, or 3.5p at 212.5p.
Stifel's analysts said: “We see the next key de-risking step a commercialisation deal that takes Lorediplon forward through late-stage development, with the US the likely focus territory.
“Further important data is expected soon with Aeterna Zentaris announcing last week that it expects to report Phase 3 results for Zoptrex in April.”
-- Adds broker comment, share price --