The shares of Acasti Pharma Inc. (NASDAQ: ACST) saw a sharp rise when the company reported that its clinical studies were making substantial progress. The day before, ACST shares had a noteworthy 19.53% increase, ultimately ending at $3.06. Growing investor trust in the company’s continuous research activities is reflected in this increasing trend.
Acasti Completed STRIVE-ON Trial Patient Enrollment
An essential stage in the assessment of GTX-104, patient registration for Acasti’s Phase 3 STRIVE-ON safety study is now complete. This trial is a prospective, open-label, randomized, parallel-group research design that compares GTX-104 with oral nimodipine in a cohort of 100 patients hospitalized for aneurysmal subarachnoid hemorrhage (aSAH).
About twenty-five hospitals throughout the country are participating in this significant trial, illustrating the wide-ranging cooperation needed to further this study.
An Understanding of Aneurysmal Subarachnoid Hemorrhage (aSAH)
The characteristic feature of the potentially fatal medical condition known as aneurysmal subarachnoid hemorrhage is blood seeping into the subarachnoid space, which is the region between the brain and bone. Serious difficulties can result from an aneurysm burst, which is frequently the source of this illness.
According to statistics, more than 30% of individuals with aSAH pass away within a month of the bleeding, and over 70% either die or become dependent on treatment for the rest of their lives. Every year, over 50,000 people in the United States alone receive a diagnosis of aSAH; instances have also been documented in China and the European Union.
ACST’s Future Expectations and Regulatory Pathway
The completion of enrollment in the STRIVE-ON trial marks a significant achievement for Acasti, occurring ahead of its anticipated timeline. The company is optimistic that if GTX-104 receives approval, it could revolutionize treatment protocols for patients with aSAH, particularly addressing the challenges associated with the administration of oral nimodipine.
Acasti (ACST) expects to announce data results from the STRIVE-ON trial in early 2025 and aims to submit a New Drug Application to the U.S. Food and Drug Administration in the first half of next year, aligning with its strategic goals. The primary endpoint of the trial focuses on safety, specifically evaluating comparative adverse events, such as hypotension, between the two patient groups.