Tuesday, March 26, 2024
Brain Trust Bio (BTB), a leading innovator in developing treatments for central nervous system (CNS) disorders, has obtained approval to initiate Phase I clinical trials in Australia for its revolutionary Continuous Intrathecal Drug Delivery Method. These trials, meeting American standards, ensure that findings will be accepted in the U.S., allowing direct progression to Phase II without repetition. This milestone is a significant step toward transforming the management of debilitating neurological conditions like amyotrophic lateral sclerosis (ALS).
Committed to innovation and patient well-being, BTB is at the forefront of redefining therapeutic approaches for CNS disorders. By optimizing an FDA-approved therapy, BTB's patented Continuous Intrathecal Drug Delivery Method aims to significantly enhance drug efficacy and patient outcomes by delivering IT-Riluzole (the only drug proven to extend survival in ALS) directly to the CNS.
The method is designed to administer therapeutic agents directly into the cerebrospinal fluid (CSF), bypassing the blood-brain barrier and allowing smaller doses to achieve a fivefold increase in delivery at the target site. This enhances the potential for neuroprotection while minimizing systemic side effects, promising a brighter future for CNS treatment.
"This approval for conducting trials signifies a pivotal moment in advancing our mission," said Chen Benkler, Ph.D., Co-Founder and CEO of Brain Trust Bio. "Our proposed treatment offers unprecedented access to CSF sampling, enabling us to provide CSF biomarker results to an extent never seen before, further enhancing our understanding and ability to treat CNS diseases."
BTB's proprietary approach has already shown promise in initial applications. Notably, two patients have been treated for over two years without adverse effects, indicating the potential to extend life expectancy and improve quality of life. With IT-Riluzole as the focus of these trials, BTB is set to explore the full potential of this innovative method in changing the course of CNS diseases.
The trials will involve 10 patients over a six-month period at two prestigious Australian sites. Led by leading medical professionals at Flinders University, Adelaide, and Sunshine Coast Hospital, Birtinya, they ensure the highest standards of clinical investigation.
Source: prnewswire.com
