Great progress during Q3 – more to come
Successful outcome of pharmacokinetic trial (phase II)
The original release included a small typo, that clinical trial 0206 investigating the pharmacokinetics of CT001 in children aged 1-17 undergoing elective surgical procedures, was a phase I study – it was of course a phase II study. We apologise for the mistake. Primary endpoint was successfully met by obtaining pharmacokinetic data in this age group, showing relevant clinical exposure ranges. In addition, secondary objectives of safety, pain assessment, and acceptance of intranasal administration was at an acceptable level (meaning no change to previous safety profile, which is a good).
The trial was designed as a non-randomised, open-label study in 25 children needing pre-medication for placement of a peripheral venous catheter for general anaesthesia related to a surgical procedure.
Start of the important pivotal trial 0205 (September)
First patient was dosed early September 2022 in the important pivotal trial 0205 of lead candidate CT001. The initiation marks that the company is now moving into a different stage with its pivotal study.
Patient recruitment is progressing, and we anticipate to finalise recruitment by the first part of 2023. The trial will investigate the postoperative analgesic efficacy of CT001, in adult participants following impacted mandibular third molar extraction, a randomised, double-blinded, placebo-controlled trial with 220 patients.
These important data are needed for the planned modelling and simulation studies of CT001. The data will replace traditional trials through extrapolation of e.g. efficacy from adults to children.
Company presentation on Nordnet (September)
If you missed the latest company presentation from last month, please visit the link on our company page (link) – here we gave a short update on the progress we have made, and in particular what we can expect in the future. There are not many late stage biotech companies on the Danish market, we are proud that Cessatech is one of them...
For more information about Cessatech, please contact:
Jes Trygved, CEO
Phone: +45 9387 2309
E-mail: jes.trygved@cessatech.com
www.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.