Product
BGC20-0166

Indication
Sleep apnoea

Description
BGC20-0166 is a proprietary combination of two marketed serotoninergic modulating drugs being developed for the treatment of mild to moderate obstructive sleep apnoea (OSA). In a recently completed clinical study, BGC20-0166 reduced the Apnoea Hypopnoea Index (AHI), a clinically accepted scale of apnoea severity, by 40% in patients with mild to severe obstructive 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 in preparation for US IND submission. Key features include:

• Potential to be the first pharmacological agent for the treatment of OSA – an under-diagnosed, under-treated condition with a high unmet need
• Once daily oral dosing – significant improvement in convenience over positive airway pressure (PAP) devices, current standard of care

Further Information
Obstructive Sleep Apnoea (OSA) in adults 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. OSA affects more than 12 million adults in America, according to the American Sleep Apnoea Association and the National Institutes of Health, making OSA as common as adult diabetes in the US.

Sleep apnoea is associated with increased risk of cardiovascular disease, including hypertension, heart failure and stroke and is also associated with increased risk of auto vehicle fatalities. OSA symptoms include daytime somnolence and decreased function, and are most frequently recognised by a sleep partner, as patients routinely do not realise disrupted breathing. Formal diagnosis 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 positive airway pressure device (CPAP). CPAP has been shown to be effective in reducing the apnoea–hypopnoea index in OSA patients. However, the overall clinical benefit of CPAP as a total solution in treating sleep apnoea is limited by relatively poor patient compliance rates reported for OSA patients. Despite this limited patient compliance, the global CPAP device market exceeded $1B in 2007. Other less frequently prescribed 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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