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INNOVATIVE PHARMACOLOGICAL APPROACH FOR THE TREATMENT OF SLEEP-RELATED BREATHING DISORDERS
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 apnoea. BGC20-0166 targets two distinct mechanisms of serotonin signaling. As the lead programme in BTG's drug repositioning portfolio, which currently consists of five development programmes 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 apnoea and represents an attractive target for pharmacologic treatment of this serious sleep related respiratory disorder" said Thomas Logan, PhD, Vice President of Drug Repositioning at BTG. "BGC20-0166 elicited a significant and sustained reduction of apnoea events in multiple preclinical studies indicating its potential as a novel pharmacologic therapy for the effective treatment of obstructive sleep apnoea. Because BGC20-0166 utilises 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 apnoea and is designed to examine the efficacy of BGC20-0166 in reducing apnoea events as determined by polysomnography. Reduction of the apnoea-hypopnoea index is the primary endpoint of the study, the results of which are expected during the second half of 2006.
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