Acasti Pharma has chosen WuXi Clinical Development to conduct its STRIVE-ON phase 3 safety trial for GTX-104, a novel injectable nimodipine formulation for intravenous infusion (IV) toaddresses high, unmet medical needs for aneurysmal subarachnoid hemorrhage (aSAH). 
 
aSAH is a rare disease that causes bleeding in the space surrounding the brain and is typically caused by leaking and bursting from weak areas in blood vessels on the brain’s surface.
 
Acasti submitted its phase 3 safety study protocol for GTX-104 to the U.S. FDA in May 2023, while preparing WuXi for the start date.
 
The trail will assess the tolerability and safety of IV nimodipine compared to oral nimodipine in hospitalized patients. The primary endpoint will be safety measured as adverse reactions including hypotension between the two groups.
  
Acasti CEO Prashant Kohli said, “WuXi is a leader in the CRO industry with a string track record in successfully helping pharmaceutical companies develop innovative therapies. Importantly, they are one of the few CROs with significant experience in aSAH and rare diseases, making them the idea partner for conducting the STRIVE-ON Phase 3 safety trial for GTX-104.”