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Regulatoriskt pressmeddelande

Cessatech announces that recruitment has today reached the halfway point for patient recruitment with 75 included patients in the Paediatric Study 0202

Cessatech
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  • 75 paediatric patients have now been recruited in Study 0202
  • Study 0202 is the final required clinical study that will evaluate the safety and efficacy profile for CT001 in children
  • CT001 is a nasal spray for the treatment of acute pain in children

On 16 October - Cessatech A/S ("Cessatech" or "the Company") announces that it has reached the halfway point for patient recruitment of its final study Paediatric Study 0202 in the development program of 0202. Study 0202 is the final required clinical study that will evaluate the safety and efficacy profile for CT001 in 150 children. The company expects the study to end the recruitment towards the end of 2024 and it is currently recruiting at different sites in Spain and UK.

CT001 is a nasal spray under development for treatment of acute and procedural pain in children. The development of CT001 in Europe is done in line with an endorsed paediatric investigation plan (PIP) by EMA's Paediatric Committee.  

Jes Trygved, CEO, Cessatech
We are very pleased with this halfway milestone in our final study for the development of CT001 in paediatric patients. We had a slow start during the summer holiday period, but since beginning of September all sites are up and running and we have recruited more than 30 patients, this is a fantastic achievement and great effort by the team - and a potentially good indication that the product is well accepted among the involved sites. CT001 is now one step closer to finalize the clinical program and becoming available to hospitals and the children that really need approved, easy to administer pain relief."

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