AI-128™
Our Inhaled Sustained Release Formulation of an Asthma Drug
AI-128 is our initial product candidate utilizing our Pulmonary Drug Delivery System or PDDS™ Technology. AI-128 is a sustained release, dry powder formulation of a widely used FDA-approved asthma drug.
Many inhaled respiratory drugs are immediate release formulations that must be inhaled multiple times per day and deliver peak and trough drug levels that can cause increased toxicity or inadequate efficacy. We believe that AI-128 is the first human demonstration of sustained release drug administration in the lung. AI-128™ consists of slowly dissolving microspheres designed to control where drug particles go in the lung and how quickly they release their drug.
A European Phase 1 clinical trial with AI-128 has been completed. In this trial, we demonstrated that approximately 80% of inhaled AI-128 was delivered to the intended target, the upper lung. These trials also demonstrated that the microspheres remained in the lung for up to 24 hours.
With once-a-day dosing, we believe a sustained release product would be more convenient for the patient, reducing non-compliance related complications and costs. Slowing drug release offers the potential for lower peak concentration of drug in the systemic circulation.
It is our current plan to seek strategic collaborators for AI-128 before commencing additional clinical testing of this product candidate.