Acasti Pharma Completes Enrollment in GTX-104 Phase 3 Trial
Acasti Pharma Completes Enrollment in GTX-104 Phase 3 Trial
PRINCETON, N.J. — Acasti Pharma Inc. (NASDAQ: ACST), a late-stage biopharmaceutical company pioneering innovative solutions for unmet medical needs, has officially completed patient enrollment in its pivotal Phase 3 STRIVE-ON safety trial. This trial specifically evaluates GTX-104, a new injectable formulation of nimodipine aiming to treat aneurysmal subarachnoid hemorrhage (aSAH), a serious condition within neurology.
Significance of the STRIVE-ON Trial
The STRIVE-ON trial represents a substantial milestone for Acasti, aiming to assess the safety of GTX-104 compared to the traditional oral nimodipine method. It involves a randomized, open-label design, with 100 patients participating across approximately 25 hospitals in the U.S. Prashant Kohli, CEO of Acasti, expressed excitement about reaching this milestone ahead of expectations, showcasing the dedication of the team and support from clinical investigators. The trial's primary goal is to evaluate safety by measuring adverse events such as hypotension experienced by the patient groups involved.
Understanding Aneurysmal Subarachnoid Hemorrhage (aSAH)
aSAH occurs when an aneurysm ruptures, leading to bleeding covering the brain's surface, significantly impacting patient survival and health outcomes. Alarmingly, around 70% of patients suffering from aSAH either die or face severe dependence post-incident, with more than 30% succumbing within the first month of hemorrhage.
Each year in the U.S., approximately 50,000 individuals are diagnosed with aSAH. In Europe, cases are estimated at about 60,000 annually, while around 150,000 cases are reported in China. The significant patient population highlights the urgent need for effective treatments.
Innovative Solutions: GTX-104 and its Benefits
GTX-104 is developed using unique nanoparticle technology which enables the aqueous formulation of nimodipine for intravenous infusion. This method represents a significant advancement, especially in intensive care environments, as it provides a straightforward intravenous delivery option. For unconscious or dysphagic patients, GTX-104 may eliminate the requirement for a nasogastric tube, thus enhancing patient comfort and treatment efficacy.
Moreover, GTX-104's intravenous formulation reduces the complications associated with oral medications, including food interactions and potential dosing errors while providing improved management for hypotension. Clinical evaluations have shown GTX-104 to be well-tolerated, having been administered to over 150 healthy volunteers with positive outcomes noted.
Expanded Market Potential
The potential market for GTX-104 in the U.S. is estimated to reach approximately $300 million, emphasizing its commercial promise as a viable treatment option for patients facing aSAH.
Other Development Candidates
Alongside GTX-104, Acasti is also focusing on GTX-102 and GTX-101. GTX-102 serves as an oral-mucosal spray of betamethasone designed to improve neurological symptoms in patients with Ataxia-Telangiectasia. Although the focus currently lies on GTX-104, Acasti retains the option to license or sell GTX-102 in the future.
On the other hand, GTX-101 is a topical bio-adhesive film-forming spray of bupivacaine aimed at alleviating symptoms of postherpetic neuralgia (PHN). With its non-narcotic formulation, GTX-101 promises a non-invasive application method, potentially offering rapid pain relief without the side effects associated with traditional oral medications.
About Acasti Pharma
Acasti is at the forefront of biopharmaceutical innovations, targeting rare diseases with its unique drug delivery technologies. By improving the efficacy and safety profiles of existing therapies, Acasti aims to deliver rapid action and greater convenience to patients. The company enjoys Orphan Drug Designation for its leading clinical assets, granting seven years of marketing exclusivity after launch in the U.S.
Frequently Asked Questions
What is GTX-104?
GTX-104 is an injectable formulation of nimodipine developed by Acasti Pharma for intravenous use in patients with aneurysmal subarachnoid hemorrhage.
What are the trial aims of the STRIVE-ON study?
The primary objective is to assess the safety of GTX-104 by comparing adverse events and effectiveness against oral nimodipine.
How many patients are involved in the STRIVE-ON trial?
The trial includes 100 patients recruited from around 25 hospitals in the United States.
When can we expect data from the STRIVE-ON trial?
Data readout from the STRIVE-ON trial is anticipated in early calendar 2025.
Why is GTX-104 necessary?
GTX-104 addresses significant challenges presented by oral nimodipine, particularly regarding administration issues in unconscious patients, while also reducing potential complications such as adverse events and dosing errors.
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