Pipeline & Platform

PT003, Pearl's lead therapeutic, is a combination product composed of glycopyrrolate and formoterol given twice daily from an HFA-MDI. The product is under evaluation to treat patients with COPD. PT003 is the only long-acting muscarinic antagonist (LAMA) plus long acting β2-agonist (LABA) combination product under development in an HFA-MDI dosage format. This dual-action bronchodilator combination offers the potential of the most rapid onset of action with the effect persisting over 12 hours. Pearl believes that PT003 offers a significant advantage to patients in terms of sustained superior efficacy overnight, complete airway coverage via Pearl’s particles, along with the reliability of Pearl's robust MDI dosage form with no drug-drug interaction in the dosage form during storage or patient use.

A study assessing the safety and pharmacokinetics of PT003 in healthy volunteers has been completed. Results support progression into patients with COPD. Pearl initiated a Phase 2b proof-of-efficacy trial in COPD patients in early 2010. Pearl has also completed a 14-day, two species, preclinical toxicology program to enable additional Phase 2b studies.