Pearl Therapeutics is presenting data from studies of its PT003 metered dose inhaler, glycopyrrolate (GP)/formoterol fumarate (FF) fixed dose combination for the treatment of moderate-to-severe COPD at a number of upcoming meetings. Pearl is also developing MDIs with each of the two component drugs, PT001 (GP) and PT005 (FF). According to the company, one of the presentations will reveal data from a Phase 2b study showing significant improvement in both morning and evening peak expiratory flow rate for patients treated with PT003 compared to placebo, open-label active controls, and the individual components.
Pearl Therapeutics Chief Medical Officer and Executive VP of Clinical Development Colin Reisner said, “It is well documented that patients with COPD experience worsening of their symptoms in the morning and evening. The significant improvement with twice-daily administration of PT003 vs placebo in home PEFR in both the morning and the evening pre- and post-dose assessments suggest that PT003 may provide benefit at the times when patients’ symptoms are known to worsen. The potential benefits of this dual-peak effect following morning and evening dosing will be evaluated further in late-stage studies.”
“We believe the depth and strength of the clinical data, and the achievements by Pearl scientists in designing robust and reproducible inhalers, substantially de-risk the Pearl bronchodilator family of products for late-stage development,” added Pearl CEO Chuck Bramlage. “We also believe that the innovations Pearl has made in respiratory drug delivery truly differentiate PT003 development from conventional inhaled product development, and set a new benchmark in capital and time efficiency in the field of pulmonary product development. We look forward to concluding the Phase 2b program in 2012 and commencing with a plan to support registration of PT003 thereafter.”
Read the Pearl Therapeutics press release.
