BGC20-0166 works by targeting two distinct mechanisms of serotonin signaling. BTG has advanced the compound 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 DR Thomas Logan, vice president of Drug Repositioning at BTG.
Dr Logan continued: “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 is the primary endpoint of the study, the results of which are expected during the second half of 2006.