Brain Trust Bio (BTB), a US-based biotechnology company involved in treatment development for central nervous system (CNS) diseases, announced on Monday that it has received approval to start phase one 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 US, 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).

The trials will involve 10 patients over a six-month period at two Australian sites and will be conducted by leading medical professionals at Flinders University, Adelaide, and Sunshine Coast Hospital, Birtinya.

Chen Benkler, PhD, Brain Trust Bio co-founder and CEO, said, 'The approval to conduct these trials signifies a pivotal moment in advancing our mission. 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.'