In an attempt to develop a next-generation combination product, GlaxoSmithKline (GSK) and Theravance, Inc have commenced large phase 2b asthma dose-optimisation studies with both the lead inhaled corticosteroid (ICS) GW685698 ('698) and long-acting beta agonist (LABA) GW642444 ('444) assets. This is part of their Horizon programme, which is dedicated to develop a next-generation combination product.
GSK began enrolling patients with mild to severe asthma in the '698 phase IIb clinical programme on December 21, 2007and began enrolling patients with persistent asthma in the '444 phase IIb clinical programme on December 29, 2007. These clinical programmes will determine the most effective doses to be taken into phase III combination studies. The phase IIb COPD programme with '444 is also on schedule to commence in 1H 2008.
Darrell Baker, senior vice president, GSK Respiratory Medicines Development Centre, said, "The programme is progressing well and we are delighted to have two very strong assets to progress into our large phase IIb studies."
"We have seen encouraging results in previous studies and have confidence in our ongoing programme. Both asthma and COPD are serious, debilitating diseases where there remains a considerable unmet need. We believe through this programme we will introduce a meaningful option for the treatment of patients with these conditions," he added.
On its part, Rick E Winningham, chief executive officer, Theravance, said, "We are very pleased to have met the important milestone of initiating the larger phase IIb studies with the lead compound '444 and with the progress of '698." "Based upon recent clinical and preclinical results, the collaboration's confidence in the overall profile of '444 has increased and we are focusing our resources on this compound to move it forward as quickly as possible. This important step brings us closer to our joint goal of bringing a new treatment option to patients in this important therapeutic area."
These studies will enrol in excess of 2,400 patients recruited globally. The '444 LABA phase IIb dose optimisation study will enrol approximately 600 patients with persistent asthma who are receiving inhaled steroids.
The '698 ICS phase IIb studies will be undertaken in three separate studies in mild, moderate and severe asthma patients with a total enrolment of 1,800 patients. All studies will be carried out using a new inhaler device. In parallel, enabling studies involving '444 and '698 given in combination will be undertaken prior to commencing large-scale phase II combination studies.
In a recently completed phase II study, '698 demonstrated once-a-day efficacy in patients with moderate asthma, with significant improvements in lung function in excess of 200mL seen within the first two weeks of dosing and maintained throughout the remainder of the 8 week treatment period, without any adverse effect on adrenal function (a marker of systemic steroid effect).
"Our goal will be to offer patients the benefit of a once-daily medication to address a significant unmet patient need. As a leader in respiratory medicine, GSK is leveraging years of experience in the development of combination products with the goal of providing physicians and patients with an effective and innovative medicine," said, Darrell Baker.
Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates. Theravance is focused on the discovery, development and commercialisation of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections and gastrointestinal motility dysfunction.