UK drug giant GlaxoSmithKline and its US partner Theravance have kicked off a mid-stage trial of an investigational drug for chronic obstructive pulmonary disorder.
The companies announced this week that the first patient has now started treatment with an investigational inhaled bifunctional compound known as GSK961081 ('081) in a Phase IIb study designed to assess its safety and efficacy and safety in moderate to severe forms of the disease.
The drug is a single molecule with dual mode of action - as both a muscarinic antagonist and a beta2 receptor agonist - which GSK licensed from Theravance under an alliance dating back to 2005, and the groups are hoping that it will prove to have a greater efficacy than single mechanism bronchodilators and with equal or even better tolerability.
The multi-centre study is randomised, double-blind/double dummy, placebo/active-controlled and parallel-group in design, and will look at the effect of '081 when administered once or twice daily over a 28-day period to determine the best dosing to take forward into Phase III clinical trials. Around 425 patients with moderate/severe COPD will be randomised in the trial, the companies noted.
Darrell Baker, SVP, Respiratory & Immuno-Inflammation, Medicines Development Centre, GSK said the firm is excited with the progress of the molecule, which, he claims, "has the potential to be an important new treatment option for patients living with COPD".
Around three million people in the UK have been diagnosed with COPD, but it is estimated that an additional 500,000 have the condition but remain undiagnosed. There is no cure for the disease and, according to patient.co.uk, it accounts for more time off work than any other illness, highlighting the need for new and effective therapies.