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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
London, UK and West Conshohocken, PA, 10 April 2008: 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 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 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 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.
“The results from this trial demonstrate the potential of this pharmacotherapy
to decrease sleep apnoea in some patients and to normalise it in others. Future
research is needed to more precisely define the role of BGC20-0166 in the
clinicians armamentarium of apnoea 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 programme.
“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 apnoea 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.
About Obstructive Sleep Apnoea (OSA)
OSA is defined as the cessation of breathing during sleep for a period of 10
seconds or more with a frequency of 5 or more events per hour of sleep. Sleep
apnoea is associated with increased risk of cardiovascular disease including
hypertension, heart failure and stroke and with increased risk of auto vehicle
fatalities. OSA symptoms include daytime somnolence and decreased function, and
are frequently first recognised by a sleep partner, as patients routinely do not
realise disrupted breathing. Formal diagnosis of OSA usually requires an
overnight sleep lab polysomnograph study. The current standard of care for OSA
patients is treatment of the disease using a variation of a continuous positive
airway pressure device (CPAP), which has been shown to be effective in reducing
the apnoea-hypopnoea index in OSA patients. However, the overall clinical
benefit of CPAP is limited by relatively poor patient compliance rates reported
for OSA patients. Despite low rates of patient compliance, the global CPAP
device market exceeded $1B in 2007. Other less frequently prescribed treatment
options for OSA patients include surgery, dental appliances and sleep position
training. Currently there are no FDA-approved drugs for the safe and effective
treatment of Obstructive Sleep Apnoea.
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About BTG
BTG in-licenses, develops and commercialises pharmaceuticals principally in
the areas of neuroscience and oncology. The company has a substantial and
growing revenue stream of royalties from out-licensed products and a broad,
expanding internal pipeline of development programmes. BTG operates from offices
in London, Philadelphia and Osaka. For further information, visit:
www.btgplc.com .
Contacts
Andy Burrows, Director of Investor Relations
+44 (0)207 575 1741
Nicole Yost, Head of Marketing
+44 (0)207 575 1619
Dr Thomas Logan, Vice President, Business & Product Development
+1 610 943 3518
Please find below the latest press release from BTG. Should you require any
further information, please contact Tony Stephenson or Claire Mosley +44 (0)20
7866 7864 or btg@collegehill.com
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