Brain Trust Bio Enters Investigational New Drug Enabled Studies for Continuous Intrathecal Drug Delivery Method

ATLANTA, August 1, 2022 — Brain Trust Bio , a next-generation biotechnology company, dedicated to improving the performance of the best medicines for central nervous system (CNS) conditions, today announced it has entered into Investigational New Drug (IND)-enabled studies for its continuous intrathecal (IT) drug delivery method.

“The acceptance of our application to enter into an IND enabled study is a huge step forward for our company,” said Chen Benkler, Ph.D., co-founder and CEO of Brain Trust Bio. “Our company was founded to provide distinct advantages over current techniques for a myriad of central nervous system diseases and disorders. Once we uncover the best precision therapy we can deliver the medicine is safer with a more efficacious result showing reduced systemic toxicity and improved cognitive clarity.”

Brain Trust Bio’s new IND-enabling program is made possible by preclinical data and research showing that its method of continuous IT administration of riluzole — combined with oral administration — has the efficacy and potential to increase spinal cord concentration of riluzole above those achievable with oral therapy alone, without increasing the risk for adverse events or off-target side effects in the brain normally associated with systemic drug exposure. IT riluzole infusion when used in conjunction with oral therapy may safely enhance lower motor neuron neuroprotection and improve the drug’s survival benefit through enhanced spinal cord delivery and, with careful selection of IT doses, could be implemented in patients with amyotrophic lateral sclerosis, or ALS.

Delivery of drugs into the central nervous system is one of the most challenging problems faced in the field of neurodegeneration treatment. Effective therapeutic strategies for neurodegenerative diseases have so far been lacking and, in many ways, inadequate. Owing to increased lifespans and population growth, central nervous system diseases are expected to increase significantly in the 21st century. This is especially true for neurodegenerative diseases, characterized by age-related gradual decline in neurological function, often accompanied by neuronal death.
Brain Trust Bio reimagines how to make existing central nervous system disease therapies more effective by optimizing the best scientific and medical innovations available. An early stage startup, Brain Trust Bio already has a proven track record and has successfully treated two patients off-label with no side effects while providing stable and prolonged neuroprotection.

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About Brain Trust Bio
Brain Trust Bio is a next-generation biotechnology company improving upon out-dated models to protect patients from avoidable neural damage from central nervous system diseases and disorders by improving the performance of already approved medicines. They do this by harnessing better drug delivery methods and allowing for medicine delivery free from the effects of metabolic differences and other inhibitors of a drug’s beneficial effects. Brain Trust Bio has entered into phase one of IND-enabling studies to secure approval to conduct in-human clinical trials.