Pipeline & Platform
Pearl Therapeutics is rapidly developing a portfolio of products that offer distinct clinical benefits to patients in the most widely used inhaled drug delivery format, the metered dose inhaler (MDI). Our hydrofluoroalkane (HFA) MDI-based products use proprietary engineered particle technology to achieve unprecedented performance and reliability from an MDI, and are intended to treat patients at all stages of chronic obstructive pulmonary disease (COPD) and asthma. Pearl has successfully formulated a majority of the bronchodilators and inhaled steroids commonly used in the respiratory space, along with their combinations, thereby demonstrating the versatility of its platform. The company is focused on developing high value combination products for patients across all stages of disease, with our lead product a twice-daily bronchodilator LAMA/LABA combination for the treatment of COPD.
Pipeline
Combination Therapy: Glycopyrrolate and Formoterol Inhalation Aerosol for COPD
Unique long-acting muscarinic antagonist (LAMA)+ long acting ß2-agonist (LABA) combination product
- New patent application filing (2Q09)
- Completed Phase 1 safety and PK study in healthy volunteers (3Q09)
- Demonstrated product stability under accelerated conditions without pharmaceutical interaction between the two actives (3Q09)
- Completed 14-day two species toxicology program, providing coverage for Phase 2b studies in the U.S. and abroad (4Q09)
- Initiated Phase 2b dose ranging study (1Q10)
Combination Therapy: Inhaled Corticosteroid (ICS)+LABA+LAMA Inhalation Aerosol
Delivery of three therapies in one inhalation
- Demonstrate proof of formulation leveraging the combination and monotherapy formulations, without a pharmaceutical interaction between the actives in single MDI
Monotherapy: Glycopyrrolate Inhalation Aerosol for COPD
LAMA bronchodilator
- Completed 14-day two species toxicology program, providing coverage for Phase 2b studies in the U.S. and abroad (4Q08)
- Filed U.S. IND (1Q09) and received clearance to proceed to Phase 2a trial in COPD
- Initiated Phase 2a proof-of-efficacy study in mild to severe COPD patients in six sites across the U.S. (2Q09)
- Completed Phase 2a study (3Q09)
- Demonstrated 12-month product stability (3Q09)
- In development as component of PT003 combination
Monotherapy: Formoterol Inhilation Aerosol for COPD
LABA bronchodilator
- Initiated Phase 2a proof-of-efficacy study in mild to severe COPD patients; only seven months from initiating formulation to dosing first patient (4Q08)
- Completed 14-day two species toxicology program, providing coverage for Phase 2b studies in the U.S. and abroad (4Q09)
- Filed U.S. IND and received clearance to proceed to Phase 2b trial following submission of IND application (4Q09)
- Demonstrated 18-month physical stability, along with formulation options for room temperature supply chain (4Q09)
- In development as component of PT003 combo
Combination therapy: ICS+LABA Inhalation Aerosol
Delivery of two therapies in one inhalation, with compelling product advantages
- Stability and performance (high respirable fraction, low nonrespirable fraction) data on multiple active combinations, fluticasone + salmeterol, budesonide + formoterol. (4Q09)