Cessatech A/S is a Danish pharmaceutical company based in Copenhagen, founded in 2020. The company focuses on developing treatments for pediatric patients, particularly in acute pain management. In 2024, Cessatech entered a commercialization partnership with Proveca for its lead product, CT001, an intranasal analgesic spray for children.[1] The company raised DKK 18.3 million in 2022 to support pivotal development activities.[2] Additionally, Cessatech secured its first US patent for CT001 in 2021, contributing to its position in the pediatric pharmaceutical market.[3] A 2024 article from Børsen highlighted Cessatech as one of the upcoming Danish biotech companies.[4]
History
editCessatech was established in 2020 with the aim of addressing unmet needs in pediatric pain management.[5][6] The company's research and development efforts focus on creating therapies suitable for children, with an emphasis on non-invasive delivery methods.
Products Under Development
editCT001
editCT001 is an intranasal analgesic spray being developed to manage acute pain in children. It combines ketamine and sufentanil and is designed for needle-free administration.[7] As of 2024, CT001 was in the pivotal stage of clinical development.
CT002
editCT002 is a nasal spray in the early stages of development, intended to sedate children during medical procedures such as MRI scans.[8] In 2024, the European Medicines Agency (EMA) approved a Pediatric Investigation Plan (PIP) for CT002.[9]
Clinical Trials
editCessatech has conducted several clinical trials to evaluate the efficacy and safety of CT001:
- Study 0201: A 2014 study on CT001's use for procedural pain in children.[10]
- Studies 0207 and 0208: Presented at the 2024 Population Approach Group in Europe (PAGE) conference, these studies involved pharmacokinetic and pharmacodynamic modeling of CT001.[11]
- Registry Study 0203: A 2024 study exploring the safety and tolerability of S-ketamine and sufentanil nasal spray in pediatric patients.[12]
Regulatory Affairs
editThe EMA agreed to Pediatric Investigation Plans for both CT001 (in 2019) and CT002 (in 2023), supporting their development for pediatric use.[13][14]
References
edit- ^ "Cessatech and Proveca announce world-wide excluding US commercial partnership for CT001". MarketScreener. 26 August 2024.
- ^ "Cessatech announces DKK 18.3 million capital raise through a 80% guaranteed rights issue to finance pivotal development of CT001". Cision News. October 2022.
- ^ "Cessatech announces the issuance of its first US patent covering CT001". MarketScreener. November 2021.
- ^ "Tre danske biotekaktier har lagt sig i spidsen på det danske aktiemarked". Børsen. 2024.
- ^ "Inhalationsbedøvelse til børn". Rigshospitalet (in Danish). Retrieved 23 September 2024.
- ^ "Cessatech A/S Member Profile". Dansk Biotek. Retrieved 23 September 2024.
- ^ "Cessatech completes pivotal study with positive results". MedWatch (in Danish). 5 June 2024. Retrieved 23 September 2024.
- ^ "Cessatech advances CT002 after EMA agreement". MedWatch (in Danish). 24 July 2024. Retrieved 23 September 2024.
- ^ "Cessatech receives EMA approval for PIP on CT002". MedWatch (in Danish). 12 April 2024. Retrieved 23 September 2024.
- ^ Nielsen, B.N. (2014). "Nasal ketamine and sufentanil for pain relief in children during wound dressing changes". Paediatric Anaesthesia. 24 (2): 170–180. doi:10.1111/pan.12268. PMID 24118506.
- ^ "Pharmacokinetic Modeling of CT001 in Pediatric Patients". PAGE Meeting 2024. Retrieved 23 September 2024.
- ^ Nielsen, B.N. (2024). "Safety and tolerability of intranasal ketamine/sufentanil in pediatric patients". Acta Anaesthesiologica Scandinavica. 68 (5): 600–610. doi:10.1111/aas.14510. PMID 39155580.
- ^ "Cessatech receives positive opinion from EMA on PIP for CT001". MedWatch (in Danish). 15 November 2019. Retrieved 23 September 2024.
- ^ "EMA approves PIP for Cessatech's CT002". MedWatch (in Danish). 3 October 2023. Retrieved 23 September 2024.