Cessatech reports last subject dosed in bioavailability trial of lead product candidate

Clinical trial 0204 in 12 healthy volunteers investigating the absolute bioavailability of CT001, reports last subject dosed ahead of timelines.  Primary aim of the trial is to demonstrate drug-exposure following nasal administration of CT001 relative to the IV injection of the approved analgesic drugs

Cessatech A/S announces that the 12-subject bioavailability trial has had the last subject dosed  in this randomized three-treatment, three-period, single dose crossover trial. The trial investigates 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. After ‘last subject, last visit’, the bioanalyses will be performed during Q3 and final results are expected during Q4’2021. 

The paediatric investigation plan (PIP) for CT001 nasal spray has been approved by the European Medicines Agency in November 2019 and this trial is a part of the clinical development plan for CT001 for treatment of acute pain in children. 

Comment from Jes Trygved, CEO of Cessatech: I am very pleased with the fast recruitment into this trial which constitutes an important part of our Pediatric Investigational Plan for CT001. There is an urgent need for better treatment of acute pain in children and thus we look forward to presenting the results of the trial later this year. Again, we are on track with the ambition plan we set forward last year, a great effort by the team.