Positive topline data from study 0205 with its lead candidate CT001 for the treatment of pain in children supporting further advancement of CT001

The study a double-blinded, randomised, placebo-controlled in adults demonstrated that CT001 was superior to… The study a double-blinded, randomised, placebo-controlled in adults demonstrated that CT001 was superior to the placebo and ketamine control arms and at par to the sufentanil control arm. CT001 was safe and well tolerated and with response analysis confirming prior observations in children and with a 50% opioid sparring effect of ketamine. The 0205 data demonstrated significant reduction in pain scale, and although superiority was not achieved for the sufentanil control arm in adults the co-primary endpoint of preliminary modelled exposure-response data substantiates that CT001 is superior in children. Exposure-response analysis supports prior observation in children in study 0201 and 0206 and supports advancement of CT001 in the planned 0202 study. 22 December – Cessatech A/S (“Cessatech” or “the Company”) today announced topline results from the double-blind, randomised, placebo-controlled 0205 study that investigated efficacy, safety, and tolerability of CT001 as postoperative analgesic treatment in adults, following impacted mandibular third molar extraction. CT001 has a significant potential to reduce pain in children as demonstrated with data from the study 0205 translated into children using the planned PKPD modelling and simulation. Although CT001 was not superior to sufentanil due to the low exposure of CT001 in adults, the co-primary endpoint of preliminary modelled exposure-response data substantiates that CT001 is superior in children. Link to release: Link https://cessatech.com/wp-content/uploads/2023/12/Study0205_high.mp4 Related articles Releases 27. August, 2026 CT001 ready for shipment to initial U.S. hospitals as launch activities commence Initial U.S. commercial supply of CT001 now available for shipment Launch activities initiated with... Read more Releases 24. July, 2026 Proveca intends to request a re-examination of CHMP opinion for CT001/KemSu See also the updated Q&A documentation related to the Release: Link The European Medicines... Read more Releases 12. June, 2026 Cessatech enters collaboration with University Hospital of Copenhagen, Rigshospitalet Cessatech enters collaboration with University Hospital of Copenhagen, Rigshospitalet, to advance an intravenous formulation of melatonin for post-anaesthesia delirium (CT004) in children ... Read more Stay up to date! Subscribe and get notified on Cessatech's latest news. An acceptance email will be sent to you, please check your spam. Please leave this field empty Almost there! Please check your inbox to confirm your subscription to Cessatech.

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