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GlaxoSmithKline and Theravance Announce Start of Large Phase 2B ICS and LABA Studies for Asthma in the Horizon Program
Date:1/3/2008

leased to have met the important milestone of initiating the larger Phase 2b studies with the lead compound '444 and with the progress of '698," said Rick E Winningham, Chief Executive Officer at Theravance. "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 enroll in excess of 2,400 patients recruited globally. The '444 LABA Phase 2b dose-optimization study will enroll approximately 600 patients with persistent asthma who are receiving inhaled steroids. The '698 ICS Phase 2b studies will be undertaken in three separate studies in mild, moderate and severe asthma patients with a total enrollment 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 3 combination studies.

In a recently-completed Phase 2 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).

Darrell Baker concluded, "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."

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