Two posters presented by Pearl Therapeutics at the 2011 European Respiratory Society meeting show additional data from a Phase 2b study demonstrating that Pearl’s glycopyrrolate (GP)/fomoterol fumarate (FF) fixed combination metered dose inhaler and its PT001 GP monotherapy MDI both provide greater inspiratory capacity than Spiriva Handihaler tiotropium dry powder inhaler. Pearl CEO Chuck Bramlage commented, “These results provide important early evidence of the broad clinical promise inherent in Pearl’s fixed-dose bronchodilator combination, PT003 for patients suffering from debilitating effects of COPD. These results strengthen our confidence in sustaining PT003’s rapid progress towards late stage clinical development in 2012.”
The study compared PT003, PT001, and PT005 (an FF monotherapy MDI) to Spiriva, Foradil Aerolizer, or placebo in patients with moderate-to-very severe COPD. Both doses of PT003 studied and the Spiriva improved IC at day one and day seven, with PT003’s higher dose showing statistically significant improvement over Spiriva on day one. At day seven, both doses of PT003 produced a statistically significant improvement in IC compared to Spiriva both pre-dose and two hours post dose.
“It has recently been shown that the progressive reduction of resting IC is associated with the development of an increasingly shallow, rapid breathing pattern and worsening shortness of breath during exercise,” noted Colin Reisner, Chief Medical Officer and Executive VP of Clinical Development for Pearl. “Improvement in IC correlates well with improvement in dyspnea at rest and with exercise, as well as overall exercise endurance. . . . These data suggest that PT003 may provide significant improvements in symptomatic benefits and exercise performance and supports further evaluation.”
Read the Pearl press release.
