Pipeline & Platform
PT005 is Pearl’s formoterol fumarate (FF) HFA-MDI product under evaluation to treat patients with moderate-to-severe COPD. FF is a well known, established, long acting β2-agonist (LABA) bronchodilator that is given twice daily and exhibits rapid onset and excellent response. It is also a highly potent molecule, with doses in the single digit microgram range, which makes it extremely difficult to formulate, particularly in MDIs. Pearl’s PT005 formulation demonstrates outstanding drug delivery performance and is stable long term.
PT005 was evaluated in a single-dose, dose ranging study in patients with COPD. The study demonstrated the capability of our HFA-MDI platform with a highly potent active, and showed equivalence to a predicate formoterol DPI based product. We have also completed a 14-day two-species toxicology program and received approval of our U.S. IND, which enables further development in a Phase 2b trial.
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.