Acasti Pharma to Host KOL Event on GTX-104: A Potential New Treatment Standard for Rare and Life-Threatening aneurysmal Subarachnoid Hemorrhage (aSAH)Virtual Webinar to Take Place October 11, 2023 at 2:00pm ET

2023-10-04

临床3期孤儿药

PRINCETON, N.J., Oct. 04, 2023 (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 it will host a virtual KOL event titled GTX-104: a potential new treatment standard for rare and life-threatening aSAH on Wednesday, October 11, 2023 at 2:00pm ET. To register, click here. The event will feature W. Taylor Kimberly, MD, PhD (Massachusetts General Hospital) who will discuss the high unmet medical need and current treatment landscape for patients suffering from aSAH, a medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull. The event will highlight Acasti's lead clinical asset, GTX-104, a novel formulation of nimodipine currently in Phase 3 targeting aSAH as an intravenous infusion. Acasti leadership will provide insight into trial design, market dynamics, and future directions. A live question and answer session will follow the formal presentations. About W. Taylor Kimberly, MD, PhD Dr. Kimberly is Chief of the Division of Neurocritical Care, and a stroke and critical care neurologist in the Department of Neurology at Massachusetts General Hospital. Clinically, he primarily cares for patients in the Neuroscience ICU as part of an integrated and multi-disciplinary team, coordinating care with Neurosurgery and Neuroendovascular specialists. He also sees Neuro ICU patients in follow-up in outpatient clinic as part of the NeuroRecovery clinical team. He serves on several hospital-based and national committees that focus on clinical guideline development and care improvement. Dr. Kimberly’s research group is located in the Center for Genomic Medicine (Kimberly Lab), and studies metabolomic and neuroimaging biomarkers of subarachnoid hemorrhage, stroke and cerebral edema. The goal of his research is to identify novel pathways and candidate therapeutic targets for the treatment of acute brain injury. Dr. Kimberly has co-led multi-site, randomized, placebo-controlled trials in the prevention of brain edema, and currently co-leads an international phase 3 trial evaluating the safety and efficacy of intravenous glibenclamide for the prevention of brain edema after large hemispheric stroke. 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. 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 GTX-104's potential to bring enhanced treatment options to patients suffering from aSAH 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 study for GTX-104; (ii) regulatory requirements or developments and the outcome and timing of the proposed IND 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 Kohli Chief Executive Officer Tel: 450-686-4555 Email: info@acastipharma.com Investor Relations: LifeSci Advisors Mike Moyer Managing Director Phone: 617-308-4306 Email: mmoyer@lifesciadvisors.com