Key achieved Milestone: Successful Regulatory Toxicology Studies Pave the Way for CBT101's Phase 1 Dear Colleagues and Partners, Ceres's team is thrilled to share the latest developments regarding our product CBT101. After months of thorough and rigorous CMC and non-clinical studies, we are pleased to announce that regulatory toxicology studies conducted in rats and dogs have yielded remarkable success. These studies represent a pivotal step in the development process of any new pharmaceutical product. They succeeded in assessing the safety and tolerability of CBT101 in a GLP environment, particularly at doses intended for human use. The remarkable results of these studies complement the exciting efficacy and cerebral biodistribution findings previously obtained. Building on these positive results, the team is now actively engaged in drafting the regulatory documents necessary to advance CBT101 into Phase 1 clinical trial. This stage marks a crucial transition in the development journey of CBT101 to finally evaluate its efficacy in patients. We want to express our gratitude to the entire team involved in this project, as well as to our partners and consultants who have contributed to this success. Together, we will continue to make significant strides in conducting clinical development of CBT101 by delivering creatine to brain neurons and addressing unmet medical needs. These include Creatine Transporter Deficiency syndrome as well as other neurodiseases with neuronal metabolic components such as Amyotrophic Lateral Sclerosis, Parkinson’ Disease, and mitochondriopathies. Stay tuned for further updates on our progresses and thank you for your continued support and dedication.
We are proud for this achievement Let's move forward
BRAVO CERES BRAIN Therapeutics 👏 nous avons hâte de participer aux futurs essais cliniques. Les familles DTC Xtraordinaire
Merci pour ce beau parcours, nous gardons espoir pour la suite. Hâte d'être en phase essais clinique avec nos enfants.
Que excelente notícia, parabéns pelos avanços nas pesquisas.
Very exciting, can’t wait to hear more about this! Will you be present at the CCDS symposium this summer Thomas Joudinaud?
Congratulation CERES BRAIN Therapeutics team.
I'd love to hear more
Félicitations à toute l’équipe !!
Congrats for this great milestone
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7moWe are so happy about this news and hope for more. Thank you for your great work for our CTD kids.