THERAVANCE ANNOUNCES RESULTS OF PHASE II STUDY

Theravance announced the results of a Phase II clinical study designed to assess the bronchodilator duration, safety and tolerability of the investigational, inhaled bronchodilator, GSK159797, the lead compound in the Beyond Advair collaboration with GlaxoSmithKline (GSK).

The results showed clinically significant increases in bronchodilation over 24 hours with little impact on heart rate at clinically relevant doses.

GSK159797 ('797) is an inhaled, longer-acting Beta2 agonist (LABA) discovered by Theravance through the application of multivalent drug design in a drug discovery program dedicated to finding new medicines for respiratory disease such as asthma.

The study was a single dose, placebo-controlled crossover design to test the bronchodilatory effect, safety and tolerability of multiple dose levels of '797 administered by a dry powder inhaler in 20 patients with mild asthma.

Doses in the anticipated clinical range produced clinically significant increases in FEV1 through 24 hours, with little change in heart rate. At 24 hours, 10 and 20 mcg doses of '797 produced adjusted mean changes from baseline FEV1 of 460 mL and 540 mL, respectively, compared to a change of 130 mL for placebo. The placebo-corrected mean maximum heart rate increase over the 26-hour period of measurement was 1.0 beats per minute (b.p.m.) for the 10 mcg dose and 2.7 b.p.m. for the 20 mcg dose.