Newsletter: Preparing for the pivotal studies....

We continue to make firm progress with the clinical activities for CT001. In May and June the team has been busy preparing for initiation of trial 0206 and, even more importantly trial 0205, which includes 220 patients. In parallel we are advancing our international activities and search for partnerships - this will be important for our future journey. We continue to strengthen the team, and I see the appointment of Adam Steensberg as the new Chairman of the Board as an important event as we are entering the late-stage development phase in the second half of this year.

Trial 0206 - site ready - first patient any day
The site has been ready for some weeks, but we have had minor practical issues to solve. We had hoped to start the study in Q2, but it will be early July. This should not have any impact on the overall timelines and we still plan to end the study in due time, by the end of the year - a few days or weeks does not make a difference. Trial 0206 in children aged 1-17 will investigate the pharmacokinetics undergoing elective surgical procedures.

Trial 0205 - the dental study - starting in 2H
The trial 0205, a dental pain study in adults, is a much bigger setup with 220 patient, which obviously requires much more preparation. The team has been working on this study for 4 months and depending on the final approval from authorities, the first patients will be recruited in 2H of 2021. The trial is a double-blind, randomised, placebo controlled study to investigate the analgesic efficacy of CT001 in patients undergoing impacted mandibular third molar extraction. I believe the logistical setup and strong commitments from the investigators will allow us to move quickly on this trial.

New chairman - meet Adam Steensberg
Adam has been appointed as the new Chairman of the Board as Cessatech moves into the next development phase. Adam is Chief Medical Officer and Head of R&D at Zealand Pharma and has been on the Board of Cessatech since August 2020. His experience in bringing medicines through late-stage development to commercialization will be important with the planned initiation of the first pivotal trial for CT001 in the second half of 2021. Adam holds a Doctor of Medical Sciences degree (D.M.Sc./dr.med.) from the University of Copenhagen and an MBA from IMD, Switzerland. Adam has published 45 peer-reviewed scientific papers in international journals.