Nimodipine

PRINCETON, N.J., Dec. 04, 2024 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) formerly Acasti Pharma Inc. (Nasdaq: ACST) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for intravenous (IV) infusion in aneurysmal subarachnoid hemorrhage (aSAH) patients to address significant unmet medical needs, today announced that the Company will be participating in the mid-year clinical meeting of the American Society of Health-System Pharmacists (ASHP) to be held December 8–12, 2024, in New Orleans, LA. “As we look forward to data readout from our Phase 3 STRIVE-ON trial in the first quarter of 2025, we are pleased to participate in the ASHP mid-year clinical meeting and to begin educating health-system pharmacists on the unmet needs in the treatment of aSAH patients and the potential of GTx-104 to address limitations with the current standard of care,” said Prashant Kohli, CEO of Grace Therapeutics. “We look forward to engaging with the ASPH community, which represents 60,000 pharmacists and other professionals in all patient care settings, including hospitals, ambulatory clinics, and health-system community pharmacies.” KOL Event on aneurysmal Subarachnoid Hemorrhage (aSAH) Grace Therapeutics hosted a virtual key opinion leader (KOL) event on November 20, 2024. The event featured Abhishek Ray, MD (University Hospitals) and Andrew Webb, PharmD, BCCCP (Massachusetts General Hospital), who discussed the high unmet medical need and current treatment landscape for patients suffering from aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency. To access the replay, click here. 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. The result is a relatively uncommon type of stroke (aSAH) that accounts for about 5% of all strokes and has an incidence of six per 100,000 person years. About the Grace Therapeutics Asset Portfolio GTx-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for intravenous (IV) infusion in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTx-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion. GTx-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of 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 administered in over 150 healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine. The addressable market in the United States for GTx-104 is estimated to be about $300 million, based on market research. About Grace Therapeutics Grace Therapeutics, Inc. (formerly Acasti, Grace Therapeutics or the Company) is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Grace Therapeutics’ 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. Grace Therapeutic’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. Grace Therapeutics’ 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. For more information, please visit: www.gracetx.com 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 Grace Therapeutics 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 the Company's upcoming participation in the ASHP mid-year clinical meeting, GTx-104’s commercial prospects; the size of the addressable market for GTx-104, and the Company’s beliefs regarding the potential benefits of GTx-104, including GTx-104's potential to bring enhanced treatment options to patients suffering from aSAH, are based upon Grace Therapeutics’ 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 Phase 3 STRIVE-ON safety trial for GTx-104; (ii) regulatory requirements or developments and the outcome and timing of the proposed NDA 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 Grace Therapeutics' 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 the "Special Note Regarding Forward-Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2024, Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2024, the Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2024 and other documents that have been and will be filed by Grace Therapeutics 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. Grace Therapeutics 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. For more information, please contact: Grace Therapeutics Contact: Prashant KohliChief Executive OfficerTel: 450-686-4555Email: info@gracetx.comwww.gracetx.com Investor Relations: LifeSci AdvisorsMike MoyerManaging DirectorPhone: 617-308-4306Email: mmoyer@lifesciadvisors.com

Danziten is set to be available soon via Biologics by McKesson and Limited Specialty Distribution. Credit: Motortion Films via Shutterstock. The US Food and Drug Administration (FDA) has approved Azurity Pharmaceuticals’ Danziten (nilotinib), the first and only nilotinib formulation that does not require mealtime restrictions, to treat chronic myeloid leukaemia (CML). It is indicated for adults with newly diagnosed Philadelphia chromosome-positive (Ph+) CML in the chronic phase, as well as those who are resistant or intolerant to previous therapies that included imatinib. Danziten’s reengineered formulation is said to provide equivalent efficacy to Tasigna but with enhanced bioavailability, enabling a lower dosage. Its approval is expected to enhance patient adherence to treatment, as it eliminates the need for fasting, which has been a challenge with current therapies. While Tasigna, the existing nilotinib treatment, has proven efficacy for Ph+ CML in chronic and acute phases, its bioavailability is affected by food intake, necessitating strict fasting to prevent cardiotoxicity. An optimal tyrosine kinase inhibitor therapy may lead to deep molecular responses, and for some patients, even treatment-free remission, the company noted. Azurity Pharmaceuticals CEO Richard Blackburn said: “Danziten offers a new nilotinib treatment option with the equivalent efficacy to Tasigna, but without the fasting requirements of Tasigna. “Unlike Tasigna, the boxed warning on the Danziten label has no requirement for patients to take their medication in a fasted state, liberating CML patients from mealtime restrictions.” Danziten is set to be shortly available via Biologics by McKesson and Limited Specialty Distribution. In September this year, the FDA approved the company’s Nymalize , an oral solution provided in a 5ml prefilled ENFit syringe as an alternative for adult subarachnoid haemorrhage patients. In 2022, it received approval for Konvomep, a treatment for active benign gastric ulcers and risk reduction of upper gastrointestinal bleeding in critically ill patients.