BTG reports positive results of sleep disorder drug

In this initial proof of concept study, 39 subjects diagnosed with obstructive sleep apnea (OSA) received placebo, a single agent or one of two doses of BGC20-0166 daily for a period of 28 days. Each subject’s apnea-hypopnea 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 10 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.

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 investigational new drug submission.

Thomas Roth, director of the sleep disorders and research center at Henry Ford Hospital, said: “The results from this trial demonstrate the potential of this pharmacotherapy to decrease sleep apnea in some patients and to normalize it in others.”