Acasti appoints WuXi to oversee STRIVE-ON trial

By Isabel Cameron

- Last updated on GMT

© Getty Images
© Getty Images

Related tags Biopharmaceutical Rare disease orphan disease Clinical trials

Acasti Pharma, a late-stage biopharma company with drug candidates addressing rare and orphan diseases, has selected WuXi Clinical Development to conduct its STRIVE-ON phase 3 safety trial for GTX-104, a novel injectable nimodipine formulation for intravenous infusion (IV) that addresses high, unmet medical needs for aneurysmal subarachnoid haemorrhage (aSAH).

WuXi is a China-based global contract research organisation (CRO) and is a wholly owned subsidiary of WuXi AppTec.

aSAH is a rare disease that causes bleeding in the space that surrounds the brain. It is typically caused by leaking and bursting from weak areas in blood vessels on the brain’s surface.

The trial will assess the safety and tolerability of IV nimodipine compared to oral nimodipine in hospitalised patients. It will include approximately 100 patients at around 25 hospitals in the US and the primary endpoint will be safety, measured as adverse effects including hypotension between the two groups.

Canada-based Acasti submitted its phase 3 safety study protocol for GTX-104 to the US Food and Drug Association (FDA) in May 2023, while making preparations with WuXi for the start date.

GTX-104 will be administered as a continuous IV infusion of 0.15 mg/hour, and a 30-minute IV bolus of 4 mg every 4 hours. Oral nimodipine will be administered at 60 mg every 4 hours.

Both groups will receive GTX-104 or oral nimodipine for up to 21 consecutive days and safety and efficacy will be evaluated from the beginning of treatment through to a 90-day follow-up period.

Prashant Kohli, CEO of Acasti, said: “WuXi Clinical is a leader in the CRO industry with a strong 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 ideal partner for conducting the STRIVE-ON Phase 3 safety trial for GTX-104.”

Related topics Clinical Development

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