Astrocyte Pharmaceuticals Receives FDA Clearance for Investigational New Drug Application for AST-004
Wednesday, March 13, 2024
Astrocyte Pharmaceuticals Inc., a clinical-stage biopharmaceutical company focused on developing therapies for stroke, traumatic brain injury (TBI), and concussion, has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for its lead program, AST-004, for acute ischemic stroke. This clearance allows the company to proceed with a Phase 2 clinical trial. Additionally, it permits further exploration of AST-004 in stroke, TBI, and concussion.
Currently, only about 5% of stroke patients receive pharmaceutical therapy due to limitations such as short treatment windows and the requirement for imaging before treatment initiation. AST-004 is designed to address these challenges by offering treatment without the need for immediate imaging and can be administered at any time post-diagnosis, potentially targeting stroke in any sized blood vessel in the brain.
The Phase 2 trial in acute ischemic stroke patients builds upon successful stroke trial designs used by medical device companies, marking a significant advancement in patient care. Dr. Kevin Sheth, Co-Director of the Center for Brain & Mind Health at the Yale School of Medicine and Chief Medical Advisor to Astrocyte, highlighted the importance of advanced imaging techniques in enabling this transformative shift in stroke trials. The study will initially focus on treating stroke patients with large vessel occlusions to minimize brain damage.
AST-004, an innovative small molecule therapy, has shown promising results in preclinical studies. In a critical non-human primate stroke model, significant reductions in brain lesion growth and overall lesion size were observed with a high dose, as reported in 'The Journal Stroke' in 2022. Astrocyte has previously conducted two Phase 1 safety trials in Europe, involving a total of 80 participants, with no significant adverse effects or safety concerns.
Dr. William Korinek, CEO of Astrocyte Pharmaceuticals, expressed the company's dedication to demonstrating the cerebroprotective benefits of AST-004 since its establishment in 2014. With a solid foundation of preclinical and Phase 1 studies, the company is eager to advance to the Phase 2 study. Given the urgent need for advancements in stroke treatment, AST-004 holds promise in addressing this global health challenge.
Source: globenewswire.com
