GlaxoSmithKline (GSK) and Theravance, Inc announced that the first patient has commenced treatment as part of the phase-III programme being undertaken to develop a next-generation combination treatment for patients with chronic obstructive pulmonary disorder (COPD), a leading cause of chronic illness and death.
The programme, referred to as ‘Horizon’, comprises a broad range of large scale phase-III studies to evaluate the investigational once-a-day long-acting beta agonist (LABA), 642444 (‘444), in combination with the once-a-day inhaled corticosteroid (ICS), fluticasone furoate (FF) for the treatment of COPD. The overall programme, which will study more than 6,000 patients, includes two 12-month exacerbation studies, two 6-month efficacy and safety studies, a detailed lung function profile study, and studies to assess the potential for superiority of the fixed combination of ‘444 and FF versus other treatments for COPD.
In addition to the COPD development programme, GSK and Theravance remain committed to the progression of the Horizon programme for the treatment of asthma and look forward to announcing further details in the coming months.
Darrell Baker, SVP GSK Respiratory Medicines Development Centre, said, “This is an ambitious programme that reflects both our confidence in the molecules selected and advances in our understanding of COPD.” He continued, “The Horizon programme signifies our commitment to prioritise the needs of patients with COPD. A unique aspect of this COPD programme is the evaluation of the doses that are best suited to COPD patients rather than simply utilising the doses used in asthma.”
“The initiation of the Horizon phase-III programme in COPD is a significant milestone for Theravance and for our collaboration with GSK," said Rick E Winningham, chief executive officer at Theravance. "COPD affects millions of people annually worldwide and contributes significantly to healthcare costs and morbidity. Patients require well tolerated, effective and more convenient treatment options. We continue to work closely with our partner, GSK, to achieve our goal of launching a best-in-class medicine.”
The selection of ‘444 and FF followed an extensive review of seven LABAs and three ICSs to select the optimal combination. To-date the Horizon programme has enrolled in excess of 3,000 asthma and COPD patients globally. The thousands of additional patients to be evaluated across the phase-III COPD studies announced today will yield a wealth of efficacy and safety data in patients treated with the ‘444/FF combination for treatment periods of up to one year.
Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates.