Pipeline & Platform
Using proprietary particle science and manufacturing technology, Pearl is developing a broad portfolio of products in the metered dose inhaler (MDI) format for the treatment of prevalent chronic respiratory diseases, including chronic obstructive pulmonary disease (COPD), asthma and rhinosinusitis. MDIs are the most widely used drug delivery format for inhaled treatments for respiratory diseases. Yet, major therapies, particularly dual and triple combinations of well-known inhaled medicines, have proven to be difficult to develop in MDI format due to formulation challenges such as inconsistent dosing, instability over time, and partial or variable delivery to the airways.
Pearl Proprietary Particles
Pearl's scientists and engineers have addressed fundamental chemistry, manufacturing and control (CMC) issues associated with MDIs by advancing a proprietary formulation technology that uses lipid-based porous particles to create stable cosuspensions with drug crystals in HFA propellants, and high performance aerosols upon actuation. This technology is suitable for formulating monotherapy and combination products as the porous particles enable efficient targeting and distribution of drug to the lungs. Pearl’s cosuspension technology does not employ any special additives such as cosolvents (ethanol), or other suspension modifying agents.
In December 2012 the U.S. Patent and Trademark Office (USPTO) issued a patent on Pearl’s novel cosuspension formulation technology for inhaled combinations. U.S. Patent number 8,324,266, titled “Compositions, Methods & Systems for Respiratory Delivery of Two or More Active Agents” covers methods for treating pulmonary disease using Pearl’s cosuspension technology in metered-dose inhalers (MDIs). More patent applications are under prosecution in several countries.
Potential Benefits of Pearl’s Innovative Platform Technology
Pearl's novel cosuspension formulation technology has the potential to deliver a broad class of highly potent drugs, both in combination products and in monotherapies. Pearl’s MDIs are designed and are in clinical testing to evaluate potential advantages to healthcare professionals and patients including:
- Reproducible dosing, from one actuation to the next, at all doses, including single-digit microgram doses of highly potent active drugs
- Uniform delivery of drug throughout the lungs for complete therapeutic coverage of the airways
- Low oral deposition, potentially resulting in a more favorable side effect profile
- Uniform stable suspensions that provide consistent dosing across drug classes (e.g. LAMA, LABA, ICS) with each actuation
- No drug crystal-crystal interaction in combination products, allowing consistent dose delivery throughout manufacturing, storage and drug delivery
- Potentially enhanced compliance due to ease of use and familiarity with the MDI dosage form, the most widely-used inhalation delivery format
- Potentially greater nocturnal control with BID (twice-daily) dosing