According to Inhalation Sciences (ISAB), topline data from a clinical trial of ISAB’s PreciseInhale aerosol generating system successfully demonstrated that the system is capable of targeting a dose to a specific lung region and that the dosing from PreciseInhale is more precise than doses delivered from a standard inhaler. The trial, which enrolled 12 healthy volunteers, found no adverse effects or safety issues. ISAB said that it plans to publish more details of the trial in peer-reviewed publications.
In May 2019, ISAB said that it had raised funds for the study necessary to validate PreciseInhale for clinical use by divesting 40,000 shares of its subsidiary Ziccum AB. More than two years later, in September 2021, the company announced that it had received permission from the Swedish Medical Product Agency (Läkemedelsverket)to conduct the trial.
ISAB Chief Scientific Officer Per Gerde said, “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.”
CEO Manoush Masarrat commented, “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, PreciseInhale will allow winner candidates to be earlier selected at a significant reduction in costs.”
Read the Inhalation Sciences press release.
