Brain Trust Bio Receives Approval for Patient Trials Targeting ALS and Other CNS Diseases with Continuous Intrathecal Drug Delivery Method
25 Mar 2024
Phase 1
ATLANTA, March 25, 2024 /PRNewswire/ -- Brain Trust Bio (BTB), a leader in treatment development for central nervous system (CNS) diseases, has received approval to commence Phase I clinical trials in Australia for its Continuous Intrathecal Drug Delivery Method. The equivalence of these Phase I trials to American standards ensures that findings will be directly accepted in the U.S., allowing for an immediate advancement to Phase II without the need for repetition. This milestone paves the way for a pioneering approach in the management of debilitating neurological conditions, including amyotrophic lateral sclerosis (ALS).
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With a commitment to innovation and patient care, BTB is at the forefront of redefining therapeutic strategies for CNS disorders. By optimizing an existing FDA-approved therapy, BTB's patented Continuous Intrathecal Drug Delivery Method aims to significantly improve drug efficacy and patient outcomes through direct delivery of IT-Riluzole (the only drug demonstrated to prolong survival in ALS) to the CNS.
This milestone paves the way for a pioneering approach in the management of neurological conditions, including ALS.
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The method is designed to deliver therapeutic agents directly to the cerebrospinal fluid (CSF), bypassing the blood-brain barrier and allowing smaller doses to achieve greater (x5) delivery at the target site. This enhances the potential for neuroprotection while minimizing systemic side effects, offering a promising outlook for the future of CNS treatment.
"The approval to conduct these 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 demonstrated potential in early applications. Notably, with two patients already treated for over two years without observed side effects, there are promising indications of its capacity to extend life expectancy and significantly enhance quality of life. With IT-Riluzole as the focal point of these trials, BTB is set to explore this innovative method's full potential in altering the course of CNS diseases.
The trials will involve 10 patients over a six-month period at two prestigious Australian sites. Conducted by leading medical professionals at Flinders University, Adelaide, and Sunshine Coast Hospital, Birtinya, they ensure the highest standards of clinical investigation.
For further information and updates, read the full details, here, and visit braintrustbio.com.
Contact:
Kissy Black
[email protected]
(615) 298-1144 x 500
SOURCE Brain Trust Bio
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