HYPNION ANNOUNCES RESULTS FROM INSOMNIA TRIAL

Hypnion has announced that its Phase II clinical trial evaluating HY10275 at doses of 1 and 3 mg in adults with transient insomnia met primary and secondary endpoints. HY10275 is a proprietary compound discovered and developed by Hypnion as a dual-acting H1/5HT2a compound using the SCORE-2004 technology.

In a randomized, double-blind, placebo-controlled study of 52 patients, HY10275 demonstrated statistically significant improvements in wake after sleep onset (WASO), an objective measure of sleep maintenance. WASO decreased in a dose-dependent manner by 62 minutes for 3 mg and 35 minutes for 1 mg compared with placebo for the primary efficacy analysis. Subjects with moderate to severe transient insomnia responded as well as or better than subjects with mild to moderate transient insomnia. HY10275 also met secondary efficacy endpoints including latency to persistent sleep. There were no adverse events attributed to treatment, and there were no reports of next-day impairment or residual fatigue.

HY10275 is a novel compound specifically designed to modulate two key neurobiological mechanisms that interfere with the sleeping process, histamine H1 and serotonin 5HT2a. Given its mechanism of action, HY10275 may have the opportunity to be classified as a non-scheduled medication. Currently approved insomnia medications that act via the GABA neurotransmitter system have been associated with physical dependence and drug-seeking behavior, and are therefore classified as controlled substances.

"The pharmacodymamic and pharmacokinetic profile of the drug coupled with its unique mechanism of action offers strong promise as a highly differentiated therapeutic," John Dee, president and CEO of Hypnion, said. "HY10275 could represent a major improvement in the treatment of insomnia as a safe, non-scheduled and well-tolerated medication with superior sleep maintenance efficacy and comparable sleep onset efficacy to currently used medications."