Published: 28. May, 2025
On 28 May – Cessatech A/S (“Cessatech” or “the Company”) announces top-line results from…
On 28 May – Cessatech A/S (“Cessatech” or “the Company”) announces top-line results from its Paediatric Study 0202, an open-label trial in the development program of CT001 an intranasal, needle-free analgesic for acute paediatric pain. The study demonstrated a rapid, clinically meaningful reduction in pain scores and confirms a favourable safety and tolerability profile for CT001. These positive data mark a key milestone towards regulatory submission in Europe and reinforce Cessatech’s commitment to delivering innovative, child-friendly pain treatments. The company and its partner, Proveca, will accordingly initiate the EMA process for submission later this year.
- The primary endpoint of responder analysis, of pain relief (pain score ≤4/10), was met and reported by 54% of patients after 15 minutes and by 88% after 30 minutes.
- Overall pain reduction was 75% after 30 minutes, and 86% after 60 minutes.
- No drug related unexpected adverse effects, and they were all transient and of mild to moderate intensity.
Jes Trygved, CEO, Cessatech “We are extremely pleased with this milestone in our final study for the development of CT001 in paediatric patients, especially as it requires significant effort to recruit so many children and to secure the trust and consent of their parents,” said Jes Trygved, CEO of Cessatech A/S. “The results clearly demonstrate that CT001 can make a meaningful difference for children who need rapid, needle-free pain relief during acute medical procedures. With this positive outcome, we are one step closer to bringing an innovative, child-friendly analgesic to children, caregivers and healthcare professionals worldwide.”
Link for full Release
