Breaking News From Pharma & Bio Ingredients
Arena Earns European Patent for Insomnia Treatment
Posted on 2005-12-29 11:49:00
Arena Pharmaceuticals, Inc. announced today that it was granted patent number 1558582, entitled "Diaryl and Arylheteroaryl Urea Derivatives as Modulators of the 5-HT2A Serotonin Receptor Useful for the Prophylaxis and Treatment of Disorders Related Thereto," by the European Patent Office. The patent relates to a class of inverse agonists to the 5-HT2A serotonin receptor, which is thought to be involved in the regulation of sleep architecture and sleep maintenance. These inverse agonists may be useful in pharmaceutical compositions for the treatment of insomnia. APD125, discovered by Arena, is an orally available 5-HT2A receptor modulator covered under the patent. Arena intends to validate the patent in 31 European jurisdictions, including Germany, France, Italy, the United Kingdom and Spain.
On June 30, 2005, Arena announced top-line results from its Phase I clinical trial program, which indicated that APD125 was well tolerated at all doses investigated and demonstrated a robust (60%) and statistically significant (p=0.0002) increase in the amount of deep, or slow wave, sleep in volunteers with normal sleep/wake patterns. An ongoing evaluation of the Phase 1 APD125 data has provided additional statistically significant signals (p is less than or equal to 0.05) indicative of improved sleep maintenance. Among the new data are statistically significant increases in stage 3 and stage 4 sleep, reductions in stage 1 sleep, reductions in the number of awakenings, and an increase in delta power during slow wave sleep. The ongoing evaluation also continues to support the encouraging preliminary safety and tolerability profile of APD125.
Arena intends to begin dosing chronic insomniacs in a Phase II clinical trial of APD125 in early 2006 under an investigational new drug, or IND, application being reviewed by the FDA. Arena expects results from the Phase II clinical trial around the middle of 2006.
"APD125 represents a promising new approach to the treatment of insomnia, and we look forward to the Phase II results," commented Jack Lief, Arena's President and Chief Executive Officer. "APD125, like our obesity drug candidate APD356, was discovered by Arena. Also like APD356, it is unpartnered and directed at a major pharmaceutical market opportunity."
Subscribe via RSS
