Inhalation Sciences Sweden AB receives CTA approval for landmark clinical trial of PreciseInhale

(Stockholm, Sweden, May 28, 2021) ISAB’s Clinical Trial Application to conduct a clinical trial of its aerosol generating system PreciseInhale[®] has been approved by the Swedish Medical Product Agency (Läkemedelsverket). CEO Manoush Masarrat: “This is a huge milestone for us. Successful clinical validation could be transformational for ISAB, unlocking new markets valued at several billion SEK, and opening up a wide range of new growth avenues.”

Following approval of the CTA the first healthy volunteers are expected to enter the clinical trial in June this year, with the study planned to be finalized before the end of 2021.

Successful clinical validation of PreciseInhale^® would make it the first aerosol generation platform that could be used from the drug discovery phase, through preclinical in vitro and in vivo studies, all the way to phase I clinical trials in humans. This could significantly reduce translational errors between research stages, accelerating drug development time and reducing risk and costs.

In a November 2020 study, co-authored with AstraZeneca, PreciseInhale^®

successfully delivered well-characterized aerosols to the deep lung regions of large animals, whose respiratory tracts closely resemble that of humans. 

In May 2021 ISAB announced the appointment of a new Scientific Advisory Board, to provide input on how to engage the inhalation research community once PreciseInhale^® is commercially available for human studies.

ISAB CEO Manoush Masarrat: “We are confident that the clinical validation of PreciseInhale^® will significantly increase the size of our market, reducing the cost and time for pharmaceutical companies and making PreciseInhale^® the leading, low-risk, high-precision aerosol delivery system on the market. I am proud of the team at ISAB who have worked so hard to make this study happen. This is a major landmark.”

For more information about Inhalation Sciences, please contact: Manoush Masarrat, CEO E-mail: Manoush.masarrat@inhalation.se Mobile: +46 (0)73 628 9153