Draft:Cessatech
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
[edit]Cessatech 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
[edit]CT001
[edit]CT001 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
[edit]CT002 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
[edit]Cessatech 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
[edit]The 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.