Inhalation Sciences AB (publ) initiates study to validate PreciseInhale for clinical use
(STOCKHOLM, SWEDEN - May 23, 2019) The Board of Inhalation Sciences (ISAB) has decided to initiate and invest in a clinical study to validate PreciseInhale for clinical use. Technical and regulatory validation is expected to take about 15 months, and will be fully financed through the divestment of a small part of ISAB's holdings in Ziccum AB.
In several pre-clinical Contract Research studies ISAB has successfully delivered clear indications of IVIVC, or In Vitro In Vivo Correlation, when pre-clinical data generated by its pre-clinical modules including DissolvIt have proved to accurately predict subsequent clinical findings. IVIVC is a well-recognized concept in the inhaled pharmaceutical industry, which constantly strives to improve its ability to reliably predict the outcome of costly and time-consuming clinical studies already during early stages of development.
Validating PreciseInhale, ISAB’s instrument for precision dosing of inhalable substances, for use in clinical as well as preclinical studies offers the inhaled pharmaceutical industry a complete research instrument that can generate predictive data end-to-end throughout drug development—from preclinical to clinical testing.
The ISAB Board and Management believe that clinical validation is of enormous commercial value. They have therefore decided to finance and implement the project on their own.
The clinical validation study aims for both the technical and regulatory validation of PreciseInhale for use in clinical studies of inhalable substances. Implementation is estimated to be approx. 15 months with the study completed by the end of 2020. The financing has been secured by disposing of 400,000 shares in Ziccum to a consortium of investors who have shown a long-sighted interest in the company, the 400,000 shares corresponds to about 18% of ISAB's total holdings. The study project will therefore be fully financed, with the transaction taking place outside the market.
ISAB CEO Lena Heffler: "A major advantage of carrying out the study ourselves is that we then own the data generated, and can use it in future publications, marketing and commercialization. Building on the research projects we recently carried out in collaboration with one of the leading companies in the inhalation industry, we assess the prospects of being able to successfully develop PreciseInhale for further clinical use as very good.”
For more information on Inhalation Sciences, please contact: Lena Heffler, CEO E-mail: firstname.lastname@example.org Telephone: +46 (0)70 205 9620Press release in PDF format