Acasti Pharma Submits Pivotal GTX-104 Phase 3 Safety Study Protocol with FDA, Implements Strategic Realignment Plan That Extends Projected Cash Runway



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.

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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 U.S. Importantly, the new team will leverage invaluable insights in aSAH from their prior experience with a focus on executional excellence to drive value for patients and Acasti’s shareholders,” Kohli concluded.

As a result of this strategic realignment, Acasti is over time discontinuing its operations in Canada, and has proceeded to lay off substantially all its workforce, allowing Acasti’s new management team to rebuild a leaner organization in the United States.

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