Pipeline & Platform
PT001 is Pearl's glycopyrrolate HFA-MDI monotherapy product under evaluation to treat patients with COPD, and an important component of Pearl’s combination product (PT003). Pearl is advancing PT001 to assess doses appropriate for both twice-daily and once-daily dosing, and to meet the FDA’s development requirements for combination products.
Pearl has moved PT001 directly into clinical trials in patients with COPD under a U.S. IND that was filed in January 2009, only seven months after identifying a development candidate formulation. PT001 was evaluated in a single-dose, dose ranging study in patients with COPD. The study demonstrated equivalence to a predicate LAMA DPI based product. Pearl also completed a 14-day, two-species preclinical toxicology program sufficient to cover development through Phase 2b, and a single-dose, dose-ranging study in the U.S.
We are currently moving formoterol forward aggressively in combination with glycopyrrolate as the first and only dual-acting bronchodilator combination product, PT003, in an HFA-MDI delivery format.