Acasti Successfully Submits Pivotal GTX-104 Phase 3 Safety Study Protocol with FDA and Implements Strategic Realignment Plan That Extends Projected Cash Runway Through Calendar Q2 2025
Company successfully submits GTX-104 Pivotal Phase 3 protocol IND amendment to the FDA with expectation for first patient dosed in calendar Q4 2023
Strategic realignment prioritizes GTX-104 and expects to extend cash runway through a potential New Drug Application (NDA) filing for GTX-104
Prashant Kohli, CEO of Acasti, commented, "We are extremely pleased to execute on this important submission milestone as we advance GTX-104, a critically important drug candidate to the thousands of patients that suffer from subarachnoid hemorrhage without effective treatment options. We expect this pivotal Phase 3 Safety Study will be the final clinical step required to seek FDA approval under the 505(b)(2) regulatory pathway."
The realignment follows a comprehensive strategic review of the company by Prashant Kohli, its recently appointed CEO, and its Board of Directors.
"As a result of the positive progress made with GTX-104, and following a strategic review, we felt it was critical to move swiftly and boldly to implement a plan that we believe will benefit Acasti's shareholders by prioritizing resources to this high-value asset," Kohli continued.
Key strategies being implemented are:
- Prioritizing resources to Acasti's biggest value driver – GTX-104. Acasti has submitted the full pivotal Phase 3 Safety Study protocol with all supporting documentation. Pending final feedback and approval from the FDA, the first patient, first dose for the pivotal Phase 3 Safety Study is expected in calendar Q4 2023.
- Strategic transformation of Acasti's operating model to an agile biopharma reflecting its complete focus on GTX-104. In alignment with the operating model, Acasti has brought on a highly experienced new management team with deep subject matter knowledge and direct, hands-on clinical trial experience in aSAH.
- Significant extension of the Company's cash runway expected to be sufficient to fund the Company through calendar Q2 2025, facilitating achievement of critical value inflection milestones, including a potential New Drug Application (NDA) filing for GTX-104.
- Evaluation of strategic alternatives to maximize value of de-prioritized pipeline assets (GTX-102 and GTX-101) including out-licensing or sale.
Vimal Kavuru, Acasti's Board Chair, added, "In today's current turbulent markets, we determined it is imperative to narrow our focus to accelerate development of GTX-104, our lead value creation driver. We believe this strategic realignment will allow us to achieve key inflection milestones without the near-term need for a significant dilutive capital raise."
In connection with the transformation of the operating model, the Company has moved to appoint the following industry experts to its senior management team:
- Dr. R. Loch
Macdonald , MD, PhD, as Chief Medical Officer. A world-renowned practicing neurosurgeon-scientist and respected authority in SAH, Dr.Macdonald is the former founder of a clinical-stage biotechnology company focused on subarachnoid hemorrhage. - Carrie D'Andrea, as VP Clinical Operations. Ms. D'Andrea is a highly experienced professional who has built and led the planning, implementation, management, and execution of global Phase 2 and Phase 3 trials for a drug candidate for subarachnoid hemorrhage.
- Amresh Kumar, PhD, as VP Program Management. Mr. Kumar is an experienced drug development, CMC, and program management expert. Amresh is the former product leader of GTX-104 while at Grace Therapeutics (which was acquired by Acasti).
"A key requirement of the strategic realignment was to build a high-performing, nimble team of professionals with specific experience in our target disease state and product knowledge. The new Acasti is a highly motivated and energized organization that is flatter, agile, and strategically closer to our addressable market opportunity in the
As a result of this strategic realignment, Acasti is over time discontinuing its operations in
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 rupture of an aneurysm. Approximately
About GTX-104
GTX-104 is a clinical stage, novel aqueous formulation of nimodipine being developed for IV infusion in aSAH patients to address significant unmet medical needs. GTX-104 provides a more convenient IV delivery of nimodipine in the ICU eliminating the need for nasogastric tube administration of the drug in unconscious or dysphagic patients. Due to IV delivery, 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 dosed in over 150 healthy subjects and was well tolerated with significantly lower inter and intra subject PK variability compared to the oral drug. The addressable market in
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
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
Acasti Contact:
Prashant Kohli
Chief Executive Officer
Tel: 450-686-4555
Email: info@acasti.com
www.acasti.com
Investor Relations:
Robert Blum
Lytham Partners, LLC
602-889-9700
ACST@lythampartners.com
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SOURCE Acasti Pharma Inc.