Topline data confirm that ISAB’s flagship aerosol generating system PreciseInhale has reached its clinical objectives, with no adverse effects or safety risks, in a recently completed clinical study of 12 subjects that was carried out by CTC (Clinical Trial Consultants), at their research clinic in Uppsala, Sweden.

A first aim of the study was to demonstrate that aerosol dosing with PreciseInhale® provides greater precision and control than dosing carried out with a standard commercial inhaler. A second aim was to demonstrate that PreciseInhale® enables “regional targeting”; the targeted exposure with aerosols in a controlled dose to specific regions of the lungs, a much sought-after capability which has not been possible previously in standard aerosol testing. Topline data confirms that PreciseInhale® has achieved these objectives.

Twelve healthy volunteers were enrolled in this study. In the first round of experiments two doses of standard asthma medicine were used: one directly from a standard commercial inhaler and the other one via PreciseInhale®. Results confirm that the accuracy of the dose delivered with PreciseInhale was greater. In a second round of experiments, it was possible to control the dosage to different regions of the lung with PreciseInhale®.

Associate Professor Per Gerde, inventor of PreciseInhale® and CSO and founder of ISAB: “Clinical validation of PreciseInhale® has always been an end goal for us. With clinical validation PreciseInhale® will be the first aerosol generating system that can be used from drug discovery, through preclinical studies into first uses in humans, reducing risk and translational errors throughout the drug development journey.” With the advent of more sophisticated particle formulations and growing recruitment of expensive macromolecules for inhaled delivery, it is increasingly important with a platform like PreciseInhale where the detailed fate of inhalants can be investigated and optimized at an earlier stage in the drug development process.

Anders Millerhovf, CEO Clinical Trial Consultants: “As experts in early clinical development, PreciseInhale gives us a unique opportunity to control the aerosol, control the dose and control the deposition site in the airways, so giving better control over the measured results. Another advantage for using PreciseInhale in early clinical trials is that the aerosol itself can be generated from even very small amounts of drug.”

ISAB’s CEO Manoush Masarrat: “This is one of the most important milestones for us to date. Clinical validation unlocks major new markets with an estimated market value of minimum 5 billion SEK. This gives the entire inhalation research sector new capabilities and I believe a new benchmark for precision and control in aerosol testing.” For research companies who develop new inhaled therapies and want to stay on the same platform from discovery over preclinical evaluation all the way into early clinical testing, PrecisInhale will allow winner candidates to be earlier selected at a significant reduction in costs.

The details of this study will be presented in the peer review publications that has now been initiated.