Healthcare Industry News: daytime sleepiness
News Release - January 5, 2007
Hypnion Announces Positive and Robust Phase II Results for Novel Sleep Drug - HY10275Primary and Secondary Efficacy Endpoints Achieved Statistical Significance
Study Validated Drug's Unique H1 / 5HT2a Mechanisms of Action
Drug Was Very Well Tolerated
LEXINGTON, Mass., Jan. 5 (HSMN NewsFeed) -- Hypnion, Inc. today announced that it met the primary and secondary endpoints in the company's initial Phase II clinical trial evaluating HY10275 at doses of 1 mg and 3 mg in adults with transient insomnia. HY10275 is a proprietary compound discovered and developed by Hypnion as a dual-acting H1 / 5HT2a compound using the SCORE-2004(TM) 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 (p<0.001) and 35 minutes for 1 mg (p<0.002) compared to 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 (LPS). There were no adverse events attributed to treatment, and there were no reports of next day impairment or residual fatigue.
"The WASO and total sleep time improvements produced by HY10275 are especially robust," said Dr. Thomas Roth, Chief, Division Head, Sleep Disorders & Research Center, Henry Ford Hospital, Detroit, MI. "In addition, latency to persistent sleep was also reduced, and was particularly strong in subjects who had difficulty falling asleep. These findings are very impressive and their scientific underpinnings offer exciting new promise for the treatment of insomnia."
Given its mechanism of action, HY10275 may have the opportunity to be classified as a non-scheduled medication. Currently used 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.
"We are very encouraged by the outcome of this initial Phase II trial, which demonstrates proof of concept for both efficacy and safety of HY10275," said John F. Dee, President and CEO of Hypnion. "The pharmacodymamic and pharmacokinetic profile of the drug coupled with its unique mechanism of action offers strong promise as a highly differentiated therapeutic. 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."
HY10275 is a novel compound specifically designed to modulate two key neurobiological mechanisms that interfere with the sleeping process. HY10275 is highly selective for histamine H1 and serotonin 5HT2a, two chemical receptors that are known to impact the ability to fall asleep and stay asleep. Born from translational sleep research pioneered by Hypnion Cofounder and Chief Scientific Officer, Dr. Dale M. Edgar, HY10275 was rationally designed to "let you sleep" rather than depress the entire brain to "make you sleep." This dual-acting receptor activity and the lack of affinity for undesired off- target receptors are thought to account for the compounds excellent efficacy and tolerability profile.
Insomnia is a serious worldwide condition that affects a large number of individuals. According to the National Sleep Foundation's Sleep in America Poll 2005, approximately 50 percent of the U.S. adult population reported experiencing at least one symptom of insomnia for several nights a week during the last year. This represents more than 100 million Americans, a figure supported by several reviews in Sleep Medicine. An estimated 30 percent to 40 percent of all adults complain of transient insomnia, generally defined as a complaint lasting up to three weeks, while 10 percent to 15 percent complain of chronic insomnia, generally defined as a complaint lasting approximately four weeks or longer. In addition, sleep maintenance insomnia, or the inability to stay asleep throughout the night, is significantly more prevalent than sleep onset insomnia.
Hypnion is a neuroscience drug discovery and development company located in Lexington, Mass., that is focused on sleep disorders. Product candidates and research capabilities address large untapped markets, including insomnia, excessive daytime sleepiness, sleep apnea, restless legs syndrome and fibromyalgia. The company was founded in 2000 by leading scientists in the field of sleep disorder research and has proprietary rights to the world's most advanced sleep-wake drug discovery system, SCORE-2004(TM). The system is highly predictive of human response and allows high-throughput pre-clinical testing of drug candidates to optimize the key attributes for the next generation of safe, non-addictive sleep disorder therapies.
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