Cessatech expects to report on its bioavailability trial 0204 within a few weeks

Report this content

Topline results of clinical trial 0204 in healthy volunteers investigating the absolute bioavailability of CT001, which was set to be announced last month, will be announced in a few weeks. Primary aim of the trial is to investigate drug-exposure following nasal administration of CT001 relative to the IV injection of approved drug counterparts

Cessatech A/S announces that the results of the bioavailability trial (0204) has been slightly delayed and will be announced within a few weeks. The trial includes adult healthy volunteers in a randomised three-treatment, three-period, single dose crossover design with a wash-out period of minimum 5 days and maximum 3 weeks. The study will investigate the absorption of CT001 nasal spray across nasal mucosa (also known as bioavailability) compared to marketed intravenous solutions of the two analgesic drugs in a standardised set-up with healthy volunteers.

Comment from Jes Trygved, CEO of Cessatech
We have received many requests related to trial 0204, which unfortunately has been slightly delayed. Initially we were waiting for the laboratory partner which has taken much longer than anticipated, partly due to the COVID situation in Austria. The data is now in the hands of the statistical company and we can expect topline results in a few weeks. The slight delay should not have any implications for the overall timelines of CT001 which still has a fantastic potential. Thanks for your understanding. 

For more information about Cessatech, please contact:
Jes Trygved, CEO
Phone: +45 9387 2309
E-mail: jes.trygved@cessatech.com

About Cessatech
Cessatech A/S is a Danish pharmaceutical company committed to developing and commercialising evidence-based and innovative medicines for children for the treatment of paediatric acute pain. Its lead asset (CT001) is an analgesic nasal spray for the treatment of acute and planned painful procedures in children. The advantages include needle-free administration, being easy to administer, a fast-acting therapeutic effect and being medically approved for children. CT001 is at its pivotal stage of clinical development.