Cessatech A/S has announced positive top-line results from its pivotal Paediatric Study 0202, marking a significant milestone for CT001, an intranasal analgesic designed specifically for acute pain management in children. The study successfully met its primary endpoint, demonstrating rapid and clinically meaningful pain relief in pediatric patients treated in emergency department settings.
Study Results Demonstrate Rapid Pain Relief
The open-label trial evaluated CT001's safety and efficacy in 152 children with moderate to severe pain due to injuries in emergency departments across Europe. The primary endpoint measured patients achieving pain intensity scores of ≤4 out of 10 at 15 and 30 minutes post-administration. Results showed 55% of patients reached this threshold within 15 minutes, increasing to 89% after 30 minutes.
Overall pain reduction was substantial, with patients experiencing a 75% reduction in pain scores after 30 minutes and 86% reduction after 60 minutes. The responder analysis revealed that 90% of children achieved at least a 30% reduction in pain after 30 minutes, while 81% experienced at least a 50% pain reduction.
Safety Profile Supports Regulatory Pathway
The study confirmed CT001's favorable safety and tolerability profile, with no drug-related unexpected adverse effects reported. All adverse events were transient and of mild to moderate intensity, with no obvious differences observed across age groups. The needle-free administration was well-received by children, parents, and physicians involved in the study.
Dr. Stuart Hartshorn, Chief Investigator of Study 0202, emphasized the clinical impact beyond statistics: "The response from children and their families often said more than any statistic: within minutes, children were visibly more settled, parents looked reassured, and you could see the relief on everyone's faces."
Regulatory Submission Timeline
With the completion of Study 0202, Cessatech has fulfilled all requirements under the European Medicines Agency's endorsed Paediatric Investigation Plan (PIP). The company and its partner Proveca will initiate the EMA submission process later this year, with potential approval targeted for 2026.
Martin Juhl, Chief Scientific Officer at Cessatech, noted the consistency between observed results and predictive modeling: "90% of children in Study 0202 experienced at least a 30% reduction in pain, after 30 minutes, which is highly consistent with the 93% predicted by our unified adult-paediatric model."
Addressing Unmet Medical Need
CT001 represents a significant advancement in pediatric pain management, offering needle-free administration with rapid onset of action. The development addresses a critical unmet need for approved, easy-to-administer pain relief options specifically designed for children undergoing acute medical procedures.
CEO Jes Trygved expressed satisfaction with the milestone: "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."
The successful completion of the clinical development program positions CT001 as a potential first-in-class treatment option for pediatric acute pain, with Proveca holding exclusive marketing rights outside North America for future commercialization.
