CERES BRAIN Therapeutics ambitions to change the paradigm of neurological diseases with bioenergetic deficiency. These diseases remain untreated since potential efficacious compounds, such as creatine (a small amino acid produced by the body and found in the food), the reservoir of energy for the cells, cannot reach the neurons. The limited access of creatine to the brain prevents the use of oral creatine as a treatment. With its unique innovative approach or prodrugs and nose-to-brain delivery, Ceres Brain Therapeutics is the only company that can bring creatine to cerebral neurons
There are numerous clinical applications: rare genetic diseases with primary lack of cerebral creatine, or mitochondria deficiencies, epigenetic diseases, and societal diseases. Ceres’s pioneer approach rescuing neurons with creatine will change patients’ life.
Ceres Brain Therapeutics‘ drug candidate, CBT101, is a creatine-prodrug.
It is administered in the nasal cavity by means of a dedicated innovative formulation delivered by a preservative-free nasal spray. In the nasal cavity, it enters the olfactory & trigeminal nerves, regardless of the creatine transporter activity. CBT101 migrates within the nerves reaching their origins: the olfactory bulb and the trigeminal core in the brain bypassing the blood brain barrier. From there, CBT101 diffuses to all brain areas delivering the missing creatine to the neurons.
Ceres’ team proved this concept in several animal models including rodents and non-human primates.
CBT101 synthesis was scaled up to batches of 5 kg. A specific innovative formulation allowing stability, tolerance, sprayability and efficacy have been developed and a batch of 60 kg was successfully produced.
Preservative-free devices are used for nasal administration.
CERES BRAIN Therapeutics was granted ODD (orphan drug designation) by the EMA and the FDA. ODD status eases the development path, reducing regulatory fees, ensuring access to specific grants, and reducing the time to market.
Creatine Transporter Deficiency syndrome or CTD is CBT101 priority indication. CTD is a rare untreated genetic disease. Key symptoms in children and adults are global development delay, intellectual deficiency, pseudo autistic behaviors and seizures. The cause is a large lack of creatine inside the brain and more specifically in neurons. CBT101proved to reverse symptoms in two different animal models of the disease and is highly promising in patient. CBT101 was granted ODD (orphan drug designation) in the Creatine Deficiencies indications by the EMA and the FDA.
Other indications and projects
Ceres Brain Therapeutics performed preclinical proofs of concept on several mitochondria diseases in vitro and in vivo models. These experiments are paving the way for other rare and more common indications for CBT101 or other creatine-prodrugs of Ceres library. Two other projects, still in the discovery stage, focus on addressing brain neurodegenerative disease and tumor.
CERES BRAIN Therapeutics, a spin-off of the CEA, was created in October 2019, by leading researchers in neurology, specialist of chemistry and blood brain barrier, a pharmacist, expert in bioanalytical chemistry, drug metabolism and pharmacokinetics, and a Medical Doctor, former cardiac surgeon, with >10-year experience in business strategy.
The project started in 2013 within the F. Joliot laboratory of the CEA where CERES’ founders began to develop new pharmacological tools and strategies to study the passage of drugs into the brain through or avoiding the blood brain barrier.
The decision to launch CERES BRAIN as a spin-off from CEA was taken in 2018, thanks to positive results on the Nose-to-Brain delivery of their innovative compound to treat Creatine Transporter Deficiency in a KO mice model and positive feedback from pharma companies. The company was founded in October 2019 by Aloise Mabondzo, Sophie Dezard, Anne-Cécile Guyot, Henri Bénech, Thomas Joudinaud and the CEA.
Aloïse Mabondzo, PhD, Research director at CEA, expert in neuropharmacology, neuroinflammation and blood brain barrier physiopathology. After his PhD thesis in virology, Aloïse joined the CEA, in the Life Science Division as the leader of a neurovascular pharmacology Lab. He coordinated different research programs in the neuroscience field. Aloïse is co-author of 65 publications in peer-reviewed scientific journals and also of 6 patents. He is the Scientific Director of Ceres Brain Therapeutics.
Sophie Dezard is an engineer in chemistry. She is a specialist in labelling compounds with carbon 14 as well as in organic synthesis. At CEA she has been involved in drug synthesis and development in collaboration with the major French pharmaceuticals companies during over 30 years. She has been in charge of the French National research Agency and European programs and she was the head of the security of the radiochemicals laboratories in CEA Paris-Saclay. Sophie is at the origin of the synthesis process of creatine-prodrug currently developed by CERES BRAIN.
COO & COFOUNDER
Henri Bénech Pharm.D., PhD is a former researcher in the fields of drug metabolism & Pharmacokinetics, also founder/leader of a pharmacological platform advising the pharmaceutical industry at the CEA. In 2012, Henri set up a business developer position in Life sciences of the CEA. Henri is also an expert in medicines pricing, having been a rapporteur at the French committee negotiating the prices of medicines (CEPS) for 5 years.
Henri is a member of the French National Academy of Pharmacy. He is co-founder and board member at Skymab Biotherapeutics.
PhD, Research director at CEA
Aloïse Mabondzo, PhD, Research director at CEA, expert in neuropharmacology, neuroinflammation and blood brain barrier physiopathology. After his PhD thesis in virology, Aloïse joined the CEA, in the Life Science Division, in May of 1998 as the leader of a neurovascular pharmacology Lab.
He coordinated different research programs in the neuroscience field. Aloïse is co-author of 51 publications in peer-reviewed scientific journals and also of 6 patents. He is the Scientific Director of CERES BRAIN