BTG Reports Positive Results from First Study Investigating BGC20-0166 in Obstructive Sleep Apnoea Patients

Novel Combination Therapy Shown to be Well-Tolerated and to Reduce the Apnoea-Hypopnoea Index in OSA Patients

14-Apr-2008

BTG reports additional details from its positive clinical proof of concept study of BGC20-0166 in subjects with mild to severe obstructive sleep apnoea. BGC20-0166 is a novel combination of two marketed serotonin modulating drugs being developed for the treatment of obstructive sleep apnoea syndrome (OSA). OSA is a sleep-related breathing disorder. BGC20-0166 has the potential to significantly advance the management of OSA as there are currently no approved drug therapies to treat this disorder.

In this initial proof of concept study, 39 subjects diagnosed with OSA received placebo, a single agent or one of two doses of BGC20-0166 daily for a period of 28 days. Each subject's apnoea-hypopnoea index (AHI) was measured in overnight sleep laboratory polysomnograph studies on days 14 and 28. The primary endpoint was a reduction in the AHI at day 28. The treatment group receiving the high-dose combination demonstrated a statistically significant reduction in AHI compared to subjects receiving placebo at both day 14 and 28. AHI was reduced by a mean of 40% in this treatment group, with individual responses ranging between 10% and 85%.

Three of ten subjects in the high-dose group were considered complete responders, with a reduction in AHI of 50% or more and an AHI below 10 at day 28. In addition to the observed overall reduction of AHI, subjects in the high-dose treatment group showed reduced AHI in both REM and non-REM sleep stages and independent of sleep position. Subjects in the high-dose treatment group also showed a trend towards improved oxygen saturation levels relative to placebo, a measure which is directly correlated with improved sleep-related breathing. These improvements in clinically accepted measures of obstructive sleep apnoea severity were not associated with a change in sleep architecture that has been reported for other candidate pharmacotherapies previously investigated for the treatment of sleep apnoea.

BGC20-0166 was shown to be well-tolerated with no significant difference in reported side-effects between active and placebo treatment groups. BTG is continuing with both non-clinical studies and the development of a proprietary product formulation with its partner Collegium Pharmaceutical in preparation for US IND submission.

https://www.bionity.com/en/news/80730/btg-reports-positive-results-from-first-study-investigating-bgc20-0166-in-obstructive-sleep-apnoea-patients.html