Acasti Pharma (NASDAQ:) Inc. (“Acasti” or the “Company”) (Nasdaq: ACST), 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 the successful submission to the FDA of GTX-104’s full protocol of its pivotal Phase 3 Safety Study and implementation of a strategic realignment plan to maximize shareholder value.
The realignment follows a comprehensive strategic review of the company by
“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.
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
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