Innovative Pharmacological Approach for the Treatment of Sleep-Related Breathing Disorders
LONDON and CONSHOHOCKEN, Pennsylvania, December 15 /PRNewswire-FirstCall/ -- BTG , the medical innovations company, announced today that it has initiated patient enrolment for a proof of mechanism clinical trial for BGC20-0166, its novel pharmacologic therapy for the treatment of obstructive sleep apnea. BGC20-0166 targets two distinct mechanisms of serotonin signaling. As the lead program in BTG’s drug repositioning portfolio, which currently consists of five development programs involving new therapeutic uses or enhanced formulation of approved drugs, BTG has advanced BGC20-0166 from preclinical validation studies to the current clinical trial in less than eighteen months. The goals of the current clinical study are to investigate the efficacy of BGC20-0166 and to establish mechanistic proof of concept.
“Serotonin signaling has been implicated as playing an important role in the pathophysiology of obstructive sleep apnea and represents an attractive target for pharmacologic treatment of this serious sleep related respiratory disorder” said Thomas Logan, Ph.D., Vice President of Drug Repositioning at BTG. “BGC20-0166 elicited a significant and sustained reduction of apnea events in multiple preclinical studies indicating its potential as a novel pharmacologic therapy for the effective treatment of obstructive sleep apnea. Because BGC20-0166 utilizes two approved chemical entities, the time to initiation of clinical proof of mechanism was greatly accelerated”
The study is expected to enroll approximately 30 patients diagnosed with moderate to severe obstructive sleep apnea and is designed to examine the efficacy of BGC20-0166 in reducing apnea events as determined by polysomnography. Reduction of the apnea-hypopnea index (AHI) is the primary endpoint of the study, the results of which are expected during the second half of 2006. In addition, BTG continues to advance its product formulation development program for BGC20-0166 with its partner Collegium Pharmaceutical. This program involves development of proprietary formulations with optimal pharmacokinetic properties as they relate to the normal sleep-wake cycle.
About Obstructive Sleep Apnea
Sleep apnea is a serious respiratory disorder that involves repeated cessation of breathing for prolonged intervals during sleep. It is estimated that 15-20 million people in the US and another 10-15 million people in Europe suffer from apnea. A recent study published in the prestigious New England Journal of Medicine by Yale University School of Medicine investigators has identified obstructive sleep apnea as an independent risk factor for stroke and death. In addition, sleep apnea has been linked to increased risk for hypertension, heart failure, depression, diabetes and automobile accidents. Current treatment for sleep apnea is limited to surgery or the positive airway pressure device which is associated with poor patient compliance and, subsequently, limited clinical benefit across the general population of apnea sufferers. Currently there are no approved pharmacologic therapies to effectively treat sleep apnea.
About BTG
BTG acquires rights to early stage pharmaceuticals and other medical technologies from a global network of corporations, universities and research institutions. The Company applies resources including finance, intellectual property and project management skills to fund and manage outsourced preclinical and clinical development programs. BTG then commercializes the technologies by licensing to pharmaceutical or medical device companies, or by creating companies to exploit them. The Company is also commercializing a range of technologies in the internet and telecommunications areas. BTG’s pipeline comprises around 50 assets at varying stages of development, contributing to an increasing range of products marketed by our licensees. BTG operates from London, Philadelphia and Tokyo. For further information visit: www.btgplc.com.
Contacts: In the US: Thomas Reilly VP, Drug Repositioning Tel: +1-610-943-3598 Thomas Logan VP, Drug Repositioning Tel: +1-610-943-3518
BTG plc
CONTACT: Contacts: In the US: Thomas Reilly, VP, Drug Repositioning, Tel:+1-610-943-3598. Thomas Logan, VP, Drug Repositioning, Tel: +1-610-943-3518
