28 May 2025 – 17.15
Cessatech announces positive top-line results from its final CT001 Study 0202
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.
In April of 2025 the Company announced the completion of patient recruitment of the final study, Paediatric Study 0202 in the development program of CT001. Study 0202 is the final required clinical study that will evaluate the safety and efficacy profile for CT001 in 152 children with moderate to severe pain due to an injury in the emergency departments. The primary endpoint was patients with pain intensity (≤4) measured at 15 minutes and 30 minutes. Pain intensity ≤4 was reported at 54% at 15 minutes and 88% after 30 minutes. The
quick onset and level of pain reduction is very encouraging and in line with previous presented data simulated from study 0208.
There were no drug related unexpected adverse effects, and they were all transient and of mild to moderate intensity. There were no obvious differences across age groups. CT001 has been very well perceived by the children involved, the parents and physicians involved in the study.
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