STOCKHOLM, SWEDEN – July 1, 2019. Inhalation Sciences AB (ISAB) has contracted Swedish CRO Clinical Trials Consultants AB to carry out its clinical study validating PreciseInhale for clinical use. CTC CEO Anders Millerhovf: “For us this is a win-win. As an innovation-focused CRO we appreciate the new value and data that a clinically validated PreciseInhale system will offer the inhalation industry and look forward to continuing to explore PreciseInhale’s highly competitive capabilities”.
ISAB has chosen Swedish CRO CTC to carry out a 15-month study to validate PreciseInhale, its flagship aerosol exposure system, for clinical use. A clinically validated PreciseInhale would enable the inhaled pharma industry to generate predictive data end-to-end, throughout drug development, from preclinical to clinical testing, on the same research instrument. This would reduce error, risk and clinical failure, and accelerate drug development. As an inhalation research tool for fast-growing, innovative CROs like CTC it would also offer formidable benefits.
Anders Millerhovf CEO CTC: “We are excited at the opportunity to work with such an innovative system. We will validate PreciseInhale in a Clinical Phase I, First in Man setting, and appreciate as research scientists PreciseInhale’s capabilities and enormous potential. We look forward to running the system and seeing how PreciseInhale performs in aerosol tests on human subjects.”
PreciseInhale is already used extensively in preclinical aerosol research, and in a recent collaboration with a leading inhaled pharma developer successfully generated highly accurate, predictive lung data in aerosol tests on larger mammals.
Lena Heffler CEO: “This is a milestone study for us that profoundly impacts the commercial potential of our technology. We couldn’t have found a better partner than CTC. With their extensive experience of preclinical to clinical work CTC understand the implications of a clinically validated end-to-end aerosol R&D tool. Like us they are adaptable, resourceful, forward-looking, and value innovation intensely. Their expertise and experience, both here in Sweden and in the US, where they have worked with Quintiles, now IQVIA, is extensive and impressive.”
The clinical validation study aims for both the technical and regulatory validation of PreciseInhale for use in clinical studies. Implementation is estimated to be approx. 15 months with regulatory approval achieved by beginning of 2020, and first patient in soon after. Financing for the Study has been secured by ISAB selling approx.. 18% of its total holdings in Ziccum to a consortium of investors with long-sighted interest in the company. Final data from the Study is expected by the end of 2020.
For more information on Inhalation Sciences, please contact:
Lena Heffler, CEO
Telephone: +46 (0)70 205 9620
About Inhalations Sciences Sweden AB (publ)
Inhalation Sciences Sweden AB (publ) develops and commercializes world-leading instruments for research into inhalation. The company’s patented lab instrument, PreciseInhale®, enables researchers to characterize, with high precision, how aerosols and small particles impact our lungs, and so our health, when we breathe them in.
About Clinical Trial Consultants AB (publ)
CTC Clinical Trial Consultants AB is a full-service CRO with focus on clinical conduct. Our mission is to facilitate clinical and translational research by providing our customers with cost-effective advice, conduct and reporting of clinical trials. We have four different departments: Clinic, Clinical Operations, Pharmacovigilance and Biometrics, all supported by independent quality assurance management.
Our head office and Phase 1 units are located in Uppsala comprising 28 beds of which 12 are hospital beds in a first-in-human approved research unit whereas our two professional sites for multicenter studies (SMOs) are found in Uppsala and Linköping. We have our own subject database for recruitment of both healthy volunteers and special patient populations.
CTC was founded in 2011 and has successfully conducted over 200 industry sponsored clinical trials for start-up companies as well as for international pharmaceutical companies and CROs. Our track record includes first-in-human, food effect, drug interaction, bioequivalence, bioavaliability and biosimilar studies, new drug delivery systems, medical device, PET/MR, QT and Phase IIa studies.
The information above was submitted, through the agency of the above contact person, for publication on July 1, 2019.