Pearl Therapeutics has announced positive top-line results from a Phase 2b dose-ranging study of its PT001 glycopyrrolate (GP) MDI in patients with moderate-to-severe COPD. The randomized, double-blind study compared 4 doses of the PT001 MDI to placebo and to Atrovent HFA inhalation aerosol. According to Pearl all of the doses of GP tested demonstrated statistically significant improvement in lung function compared to placebo, and several doses were “non-inferior to Atrovent HFA” with no identified safety problems. PT001 is a long acting muscarinic agonist (LAMA), which Pearl is also developing in combination with formoterol in its PT003 LAMA/LABA combination MDI, and the new study provides dose ranging data for that product as well.
“This Phase 2b study provides important information about the safety and efficacy of GP MDI, the LAMA component of PT003, our lead combination bronchodilator candidate for the treatment of COPD. Further, the activity profile of GP MDI in this study is consistent with that observed in two previously reported studies and supports the BID dosing that we believe will provide the best symptom relief for patients with moderate-to-severe COPD,” noted Pearl Chief Medical Officer and Executive VP of Clinical Development Colin Reisner.
Pearl CEO Chuck Bramlage added, “A significant part of the very large COPD market is driven by the use of BID LABAs and inhaled corticosteroids. However, a rapid-acting, BID LAMA to complement these options is not yet available.We believe GP MDI has the clinical profile to fill this treatment gap and become a best-in-class LAMA monotherapy. In addition, GP MDI is a key component of our combination bronchodilator PT003, which, pending the successful completion of our remaining Phase 2b studies, we expect to advance into Phase 3 trials in 2012.”
Read the Pearl Therapeutics press release.
