BTG Reports Positive Results from First Study Investigating BGC20-0166 in Obstructive...

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

LONDON & WEST CONSHOHOCKEN, Pa.--(Business Wire)--
BTG (LSE: BGC), the life sciences company, today reports
additional details from its positive clinical proof of concept study
of BGC20-0166 in subjects with mild to severe obstructive sleep apnea.

BGC20-0166 is a novel combination of two marketed serotonin
modulating drugs being developed for the treatment of obstructive
sleep apnea syndrome (OSA). OSA is a sleep-related breathing disorder
that affects more than 12 million adults in the US, according to the
National Institutes of Health, making OSA as common as adult diabetes.
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 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 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
apnea 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 apnea.

"The results from this trial demonstrate the potential of this
pharmacotherapy to decrease sleep apnea in some patients and to
normalize it in others. Future research is needed to more precisely
define the role of BGC20-0166 in the clinicians armamentarium of apnea
therapy," said sleep expert, Dr. Thomas Roth, current Director of the
Sleep Disorders and Research Center at Henry Ford Hospital and former
president of the National Sleep Foundation, who is serving as an
advisor to the BTG program.

"The BGC20-0166 drug combination is based on our understanding of
the serotonin neuropharmacology associated with sleep-related
breathing," said Dr. Russell Hagan, Head of R&D at BTG. "We are
encouraged by the positive findings from this trial, and we believe
that BGC20-0166 could be an effective therapy for a significant
proportion of sleep apnea patients."

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.

College Hill for BTG
Tony Stephenson/Claire Mosley
+44 (0)20 7886 7864
btg@collegehill.com

Copyright Business Wire 2008