Acasti Announces Poster Detailing its GTX-104 STRIVE-ON Trial
Acasti Pharma Inc. (ACST) announces that its pivotal Phase 3 STRIVE-ON safety trial has been accepted for presentation at the 2024 International Stroke Conference. The trial focuses on the safety and tolerability of GTX-104, a novel formulation of nimodipine, in patients with aneurysmal subarachnoid hemorrhage (aSAH). The trial design includes approximately 100 patients enrolled at 25 hospitals in the U.S., with the primary endpoint being comparative adverse events, including hypotension, between patients administered GTX-104 and oral nimodipine. The results will be presented at the conference on February 8th.
Aneurysmal subarachnoid hemorrhage (aSAH) is a rare condition with significant mortality and morbidity, making the development of effective treatments a critical area of medical research. The STRIVE-ON trial's focus on the safety and tolerability of GTX-104, particularly in comparison to the standard oral nimodipine treatment, is a key step in potentially offering a new therapeutic option for aSAH patients. Intravenous (IV) administration of medication can have advantages over oral administration, such as providing a more controlled and steady absorption of the drug, which is particularly important in managing acute conditions like aSAH.
From a research perspective, the primary endpoint of comparative adverse events, including hypotension, is crucial because it addresses the immediate safety concerns that could impact patient care. Hypotension, or low blood pressure, is a common and serious complication in aSAH due to the disruption of cerebral autoregulation. A treatment that can minimize this risk while effectively managing the condition could significantly improve patient outcomes. The trial design, which includes a relatively small sample size of approximately 100 patients but across an estimated 25 hospitals, suggests a focused approach that may provide robust safety data across different care settings.
The economic implications of developing a new treatment for a rare disease like aSAH can be substantial. GTX-104's advancement through clinical trials represents not only a potential improvement in patient care but also a significant investment by Acasti Pharma Inc. The healthcare system often faces challenges in allocating resources for rare conditions and the introduction of a new treatment option could influence cost-effectiveness analyses and reimbursement decisions.
It is important to consider the potential economic impact of GTX-104's IV administration. If proven to be safer or more effective than oral nimodipine, this could lead to changes in hospital protocols and potential shifts in healthcare spending towards the new treatment. However, the cost associated with IV treatments, which typically require in-hospital administration and monitoring, could be higher than oral medications, affecting the overall cost-benefit ratio. This could impact the adoption rate of the new treatment and ultimately influence Acasti Pharma's market potential and revenue projections.
The acceptance of Acasti Pharma's poster at the International Stroke Conference is an important milestone for the company. It provides a platform to showcase the research and potentially attract interest from the medical community, investors and potential partners. The biopharmaceutical industry pays close attention to such events as they often serve as indicators of a drug's potential and the company's scientific credibility.
Investors and industry stakeholders will be particularly interested in the results of the STRIVE-ON trial due to the orphan drug status often granted to treatments for rare diseases like aSAH, which can offer benefits such as market exclusivity, tax credits and waived FDA fees. These incentives can significantly enhance the profitability of a successful drug. It is also worth noting that the trial's open-label design may accelerate the data collection process, but it lacks the placebo control that can strengthen the validity of the results. The choice of a 90-day follow-up period is a balance between assessing immediate safety outcomes and understanding longer-term effects, which is relevant for both clinicians and investors.
02/01/2024 - 08:00 AM
Accepted for Presentation at the 2024 International Stroke Conference
PRINCETON, N.J., Feb. 01, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that a poster outlining its pivotal Phase 3 STRIVE-ON safety trial (the STRIVE-ON trial–NCT05995405 ) has been accepted for presentation at the 2024 International Stroke Conference , to be held February 7-9, 2024 in Phoenix, AZ.
The poster, Safety and Tolerability of Intravenous Versus Enteral Nimodipine in Patients with Aneurysmal Subarachnoid Hemorrhage , will be presented Thursday February 8th during the Ongoing Clinical Trials session of the conference.
The STRIVE-ON trial is a prospective, open-label, randomized (1:1 ratio), parallel group trial of GTX-104 compared with oral nimodipine, in patients hospitalized for aSAH. Key trial design features include:
Approximately 100 patients are expected to be enrolled at an estimated 25 hospitals in the U.S. The primary endpoint is safety and will be measured as comparative adverse events, including hypotension, between the two groups. 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 as 60 mg (two 30 mg capsules) every 4 hours. Both groups will receive their assigned GTX-104 or oral nimodipine for up to 21 consecutive days and will be evaluated from commencement of patient treatment through a 90-day follow-up period. About aneurysmal Subarachnoid Hemorrhage (aSAH)
aSAH is bleeding over the surface of the brain in the subarachnoid space between the brain and the skull, which contains blood vessels that supply the brain. A primary cause of such bleeding is the rupture of an aneurysm. Approximately 70% of aSAH patients experience death or dependence, and more than 30% die within one month of hemorrhage. Approximately 50,000 patients in the United States are affected by aSAH per year, based on market research.
About GTX-104
GTX-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for intravenous infusion (IV) in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTX-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion.
GTX-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTX-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTX-104 has the potential to better manage hypotension in aSAH patients. GTX-104 has been administered in over 150 healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine. The addressable market in the United States for GTX-104 is estimated to be about $300 million , based on market research.
About Acasti
Acasti is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Acasti's novel drug delivery technologies have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery. Acasti's lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection with over 40 granted and pending patents. Acasti's lead clinical asset, GTX-104, is an intravenous infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull.
For more information, please visit: https://www.acasti.com/en .
Forward-Looking Statements
Statements in this press release that are not statements of historical or current fact constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and "forward-looking information" within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Such forward looking statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Acasti to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements containing the terms "believes," "belief," "expects," "intends," "anticipates," "estimates", "potential," "should," "may," "will," "plans," "continue," "targeted" or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The forward-looking statements in this press release, including statements regarding the Company's anticipated cash runway, the anticipated timing of the completion of the Company's STRIVE-ON trial, the Company's anticipated NDA submission with the FDA, the anticipated use of proceeds raised in the Company's recent private placement offering, and GTX-104's potential to bring enhanced treatment options to patients suffering from aSAH and become the new standard of care in aSAH treatment are based upon Acasti's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions of the planned Phase 3 safety trial for GTX-104; (ii) regulatory requirements or developments and the outcome and timing of the proposed NDA application for GTX-104; (iii) changes to clinical trial designs and regulatory pathways; (iv) legislative, regulatory, political and economic developments; and (v) actual costs associated with Acasti's clinical trials as compared to management's current expectations. The foregoing list of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in documents that have been and are filed by Acasti from time to time with the Securities and Exchange Commission and Canadian securities regulators. All forward-looking statements contained in this press release speak only as of the date on which they were made. Acasti undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by applicable securities laws.
Acasti Contact:
Prashant Kohliinfo@acastipharma.com www.acasti.com
Investor Relations:
LifeSci Advisorsmmoyer@lifesciadvisors.com
What is the significance of the Phase 3 STRIVE-ON safety trial for Acasti Pharma Inc. (ACST)?
The Phase 3 STRIVE-ON safety trial focuses on the safety and tolerability of GTX-104, a novel formulation of nimodipine, in patients with aneurysmal subarachnoid hemorrhage (aSAH).
Where will the results of the Phase 3 STRIVE-ON safety trial be presented?
The results will be presented at the 2024 International Stroke Conference, to be held February 7-9, 2024 in Phoenix, AZ.
What is the primary endpoint of the Phase 3 STRIVE-ON safety trial?
The primary endpoint is comparative adverse events, including hypotension, between patients administered GTX-104 and oral nimodipine.
How many patients are expected to be enrolled in the Phase 3 STRIVE-ON safety trial?
Approximately 100 patients are expected to be enrolled at an estimated 25 hospitals in the U.S.
What are the key trial design features of the Phase 3 STRIVE-ON safety trial?
Key trial design features include continuous IV infusion of GTX-104 and oral nimodipine administration for up to 21 consecutive days, with evaluation through a 90-day follow-up period.
