Acasti Pharma announces patents for GTX-104 in Europe,

LAVAL, Quebec, March 22, 2022 (GLOBE NEWSWIRE) — Acasti Pharma inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), announces the following patent notifications and awards relating to the Company’s three lead drug candidates:

  • The European Patent Office has notified its intention to grant the company’s composition patent for GTX-104, an intravenous formulation of nimodipine for use in the treatment of patients with subarachnoid hemorrhage. The patent should be valid until 2037.
  • The United States Patent and Trademark Office has issued notice of acceptance of the company’s composition patent for GTX-102, a new, easy-to-use formulation of betamethasone for the oral mucosa intended to improve symptoms of ataxia-telangiectasia (AT) . AT is a progressive neurodegenerative genetic disease that mainly affects children, causing severe physical disability, for which no treatment currently exists. The patent should be valid until 2037.
  • The Japan Patent Office has granted a composition of matter patent for the Company’s GTX-101 topical spray targeting postherpetic neuralgia (PHN). PHN is a persistent and often debilitating neuropathic pain caused by nerve damage caused by the varicella zoster (shingles) virus, which can persist for months or even years. GTX-101 could offer significant advantages over the current standard of care, including greater convenience, faster onset of action, and longer duration of pain relief. The granted patent is valid until 2036.

“We are delighted to announce these latest patent notifications and awards, which significantly strengthen the intellectual property around Acasti’s three core programs, GTX-104, GTX-102 and GTX-101,” commented Jan D’Alvise, Chairman and CEO of Acasti. “These patents extend our intellectual property protection through at least 2036 and further validate our unique approach to drug development by combining new drug delivery technologies with established therapies to improve efficacy and safety, increase patient compliance and improve patient outcomes in a variety of rare and orphan diseases. We believe that these drug candidates could also benefit from a faster path to regulatory approval and commercialization through the FDA’s 505(b)(2) pathway. We are actively advancing each of these clinical programs and look forward to providing updates on our progress. »

About Acasti

Acasti is a late-stage specialty pharmaceutical company with drug delivery technologies and 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, increased efficacy, reduced side effects and more convenient drug delivery, all which could help increase treatment adherence and improve patient outcomes.

Acasti’s three core clinical assets have each received orphan drug designation from the U.S. Food and Drug Administration, which grants the assets seven years of market exclusivity after launch in the U.S., and additional protection from intellectual property with over 40 granted and pending patents. . Acasti’s main clinical assets target underserved orphan diseases: (i) GTX-104, an intravenous infusion targeting subarachnoid hemorrhage, a rare and life-threatening medical emergency in which bleeding occurs on the surface of the brain in the subarachnoid space between the brain and the skull; (ii) GTX-102, an oral mucosal spray targeting ataxia-telangiectasia, a progressive neurodegenerative genetic disease that mainly affects children, resulting in severe disability and for which no treatment currently exists; and (iii) GTX-101, a topical spray, targeting postherpetic neuralgia, a persistent and often debilitating neuropathic pain caused by nerve damage caused by the varicella zoster (shingles) virus, which can persist for months or even years. For more information, please visit: https://www.acastipharma.com/fr.

Forward-looking statements

Statements contained in this press release that are not statements of historical or current facts constitute “forward-looking information” within the meaning of Canadian securities laws and “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act. 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 (collectively, “Forward-Looking Statements”). These forward-looking statements involve known and unknown risks, uncertainties and other unknown factors that could cause Acasti’s actual results to differ materially from historical results or any future results expressed or implied by these forward-looking statements. . In addition to statements that explicitly describe such risks and uncertainties, readers are urged to review statements containing the terms “believes”, “believes”, “expects”, “intends”, “anticipates”. , “potential”, “should”, “may”, “will”, “plan”, “continue”, “targeted” or other similar expressions as uncertain and forward-looking. Readers are cautioned not to not place undue reliance on these forward-looking statements, which speak only as of the date of this press release.

The forward-looking statements contained in this press release are based on Acasti’s current expectations and involve assumptions which may never materialize or may prove to be incorrect. Actual results and timing of events could differ materially from those anticipated in such forward-looking statements due to various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions of preclinical studies and Acasti clinical trials; (ii) regulatory requirements or changes; (iii) changes to clinical trial designs and regulatory pathways; (iv) legislative, regulatory, political and economic developments, and (v) the effects of COVID-19 on clinical programs and business operations. 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 the statements that are included here and elsewhere, including the section “Special Note Regarding Statements forward-looking statements” contained in Acasti’s most recent Annual Report on Form 10-K and most recent Quarterly Report on From 10-Q, which are available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar /shtml and in the investor section of Acasti’s website at www.acastipharma.com. 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 these 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.

Neither NASDAQ, TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

Contact Acasti:
Jean d’Alvise
Chief Executive Officer
Tel: 450-686-4555
E-mail: info@acastipharma.com
www.acastipharma.com

Investor Contact:
Crescendo Communications, LLC
Tel: 212-671-1020
E-mail: ACST@crescendo-ir.com

Media contact:
Jules Abraham
JQA Partners, Inc.
Tel: 917-885-7378
Email: jabraham@jqapartners.com

Mary I. Bruner