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A short update on our key priorities and some of the most important events for the remaining part of 2024 - we are off to a good start and looking forward to a year with many achievements.
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Thank you for reading and supporting Cessatech !
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The US launch is almost there...
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CT001 launch under the Early Access program in the US is approaching
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Both teams have been very busy preparing for the launch under the Early Access Program in the US - and we are still waiting for the final approvals before we can initiate the first sale. Moving to a new manufacturing setup takes time and much effort, both we are almost there. We expect first sales during second half of 2024 (previously first half of 2024).
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Brand name, final packaging and much marketing material is done and and we are eager to share this once the launch of the first CT001 packs is official, but we are very satisfied with the design and the quality and have received very positive feedback from the physicians that has seen the material. The visual material will always be interesting for a launch, even if it is an Early Access Program, and the teams have worked hard to optimize and finalize.
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More paediatric data to be presented at IASP 2024, World Congress on Pain
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Paediatric data is fundamental in later potential approval and commercialisation
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Poster presentation next week (Tuesday 6 August)
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At IASP 2024, the World Congress on Pain, which will take place 5-9 August in Amsterdam, Cessatech will be presenting a Poster with results from our modeling and simulation studies 0207 and 0208, based the new developed unified PK-PD model, encompassing all available paediatric and adult study data (0201, 0204, 0205, and 0206) are shared. This presentation represents a culmination of our recent research efforts and provides valuable insights into CT001's efficacy across different age groups. The unified PK-PD model is a significant advancement in our understanding of drug combination’s behavior and will play a crucial role in our regulatory submissions and commercial launch strategies.
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Short update on Paediatric Safety Study 0202
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We are pleased to report that the final CT001 pediatric safety study is well underway at emergency departments across Spain and the United Kingdom. This study is an important milestone in developing new evidence-based medicines for children and providing hospitals with alternatives to off-label, unapproved treatments in pediatric patients, as is current practice.
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Early reports from all sites have been positive, providing encouraging initial results. Notably, our preliminary data show only a few adverse events (AEs), which are mainly mild and common. These initial safety findings suggest a favorable risk profile for CT001 in pediatric patients, although it's important to note that CT001 is not yet an approved medication.
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This ongoing study represents a significant step in our commitment to improving pediatric care and ensuring the safe, effective treatment of pain in children. We are eager to continue pursuing this important goal and to further validate the safety of CT001.
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As we progress, we will continue to monitor the study closely, with a particular focus on the safety data. We look forward to providing further updates as more information becomes available from this critical final study.
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Commercial partnerships for Europe is also a key priority...
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Commercial partnership for Europe is also a key priority for the Company. While we have focused significantly on the US partnership and the upcoming launch of CT001, we have in parallel continued our process for developing our partnership strategy in Europe.
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The European partnership process was initiated in 2023, and we anticipate announcing an update during the second half of 2024. We are pleased to report that we have engaged in numerous productive discussions and are optimistic about establishing an effective model for Europe. We look forward to presenting more on the structure later this year.
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FOR PAIN TREATMENT OF CHILDREN.
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Studies show that off label use of medication is the rule rather than the exception and that 79% of the emergency rooms in Scandinavia use physical restraint on children.
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Cessatech aims to meet that need – and the first product and lead asset, CT001, is a nasal spray for children aged 1-17 years that experience acute pain or pain related to medical procedures.
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Drugs that are developed by Cessatech should be proven effective in adults and represent a medical unmet need in children where a good effect can be documented. Thus offering economic value creation by identifying and developing drugs with a short time to market and risk-reduced profile.
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