Cessatech reports first patient dosed in final Safety Study 0202 of lead product candidate CT001
- First patient has been dosed in Safety Study 0202 of lead candidate CT001.
- The Safety Study 0202 is an open-label, prospective study to assess safety, tolerability, analgesic effect, and feasibility of CT001 in 150 paediatric patients with moderate to severe pain, in the emergency setting.
- Cessatech expects the study to be completed by the end of 2024.
27 May - Cessatech A/S announces that the Safety Study 0202 has now been initiated with dosing of the first patient. The trial will assess safety, tolerability, analgesic effect, and feasibility of CT001 in 150 paediatric patients with moderate to severe pain, in the emergency setting.
The paediatric investigation plan (PIP) for CT001 nasal spray has been approved by the European Medicines Agency, and Safety Study 0202 is part of the clinical development plan for treatment of acute pain in children.
Comment from Jes Trygved, CEO of Cessatech
“We are very pleased with the initiation of this important and final trial for CT001, and the company is now moving into a different stage with last study - great work and effort by all the people involved in the preparation and initiation of this trial, including the countries and sites involved. CT001 is getting closer to the market and its potential patients and the period ahead will be extremely interesting”.
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 commercializing 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, easy administration, a fast-acting therapeutic effect, and being medically approved for children. CT001 is at its pivotal stage of clinical development, and CT002 is at the early development phase.