GSK begins phase III COPD trials
pharmafile | October 28, 2009 | News story | Research and Development, Sales and Marketing | COPD, GSK, GlaxoSmithKline, Seretide, Theravance, resp, respiratory
GlaxoSmithKline and San Francisco biopharma firm Theravance have begun a phase III trial to develop a new treatment for chronic obstructive pulmonary disease (COPD).
The life-threatening progressive lung condition, which restricts breathing, already affects millions of people and is expected to be the third leading cause of death worldwide by 2020.
The Horizon programme, encompassing more than 6,000 patients, will evaluate the investigational once-a-day long-acting beta agonist 642444 (‘444).
It will be studied in combination – for up to 12 months – with the inhaled corticosteroid fluticasone furoate (FF), the main ingredient of GSK’s allergic rhinitis product Veramyst/Avamys.
More than 3,000 asthma and COPD patients have already been enrolled worldwide and will receive either FF or ‘444 on their own, an FF/’444 combination or placebo.
Primary endpoints will measure ‘444’s speed of improvement in lung
0 to 4 hours combined with the impact of FF sustaining this improvement over a 24-hour period.
Secondary endpoints will measure quality of life as determined by shortness of breath, as well as improvement from baseline.
GSK and Theravance will also use Horizon to look at potential asthma treatments.
But Darrell Baker, senior vice president at GSK’s Respiratory Medicines Development Centre, said the COPD programme would concentrate on “evaluation of the doses that are best suited to COPD patients rather than simply utilising the doses used in asthma”.
The companies say they chose ‘444 and FF after reviewing seven long-acting beta agonists and three inhaled corticosteroids.
GSK is already well aware of the potentially lucrative returns on COPD for pharma companies.
Its own drug Seretide, licensed to treat both COPD and asthma, was the top-selling respiratory brand in England last year, with sales of almost £330 million.
The COPD indicator in the Quality and Outcomes Framework introduced last year appears to have led to an upsurge in prescriptions of such products.
It has meant that GPs are more likely to test patients with symptoms to see if they are likely to benefit from treatment.
Seretide’s rivals, AstraZeneca’s Symbicort and Boehringer Ingelheim’s Spiriva, had combined sales of more than £200 million.
And the British Lung Foundation estimates there are two million more sufferers in the UK than the 900,000 who have been diagnosed.
COPD is the fifth biggest killer in the UK, and the only major cause of death on the increase.
Horizon will comprise two 12-month exacerbation studies, two six-month efficacy and safety studies, a lung function profile study and an assessment of ‘444/FF versus other COPD treatments.
Patients will be dosed using a newly-developed dual strip delivery device.
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