LAVAL, Quebec, Sept. 27, 2021 (GLOBE NEWSWIRE) – Acasti Pharma Inc. (âAcastiâ or the âCompanyâ) (Nasdaq: ACST and TSX-V: ACST), today announces the launch of its pharmacokinetic project (PK) transition study to assess the relative bioavailability of intravenous (IV) GTX-104 compared to currently marketed oral nimodipine capsules in 50 healthy subjects. The PK study is the next required step in the proposed 505 (b) (2) regulatory path for the GTX-104.
The results of this study are expected in the first half of calendar year 2022, and after review with the United States Food & Drug Administration (FDA), will help determine the final design of the phase safety study. 3 planned by the company for GTX-104 in subarachnoid hemorrhage. patients (HSA). Assuming the PK study and related FDA review are progressing as planned, the Company plans to begin the Phase 3 study in the second half of 2022. GTX-104 is a new IV infusion of nimodipine in the pipeline. development to treat SAH, which is a condition of the central nervous system. that causes acute brain hemorrhage and requires immediate medical attention to prevent long-term disability or death. GTX-104 has received orphan drug designation from the FDA, which could give Acasti seven years of market exclusivity, tax incentives, and other economic benefits.
Jan D’Alvise, President and CEO of Acasti, said: âWe are advancing rapidly in our clinical pipeline and are proud to have already launched this PK transition study of GTX-104 in the short time since the launch. finalization of our acquisition of Grace Therapeutics at the end of August. This latest study follows an earlier crossover safety and dose escalation study conducted by Grace, which reported encouraging results. “
âWe believe that GTX-104 has the potential to improve bioavailability and reduce within-subject variability compared to oral capsules, which could result in better blood pressure control in these critically ill patients. Additionally, it could provide a more convenient dosage regimen that would be easier to administer to unconscious patients. AHS is a devastating disease that affects more than 50,000 patients per year in the United States and is one of the most expensive acute conditions to treat. As a result, we believe that GTX-104, with our unique formulation, has the potential to address a significant market opportunity with a significant unmet medical need, âD’Alvise concluded.
The PK transition study is a single-center, randomized, two-period crossover study in 50 healthy subjects. The primary objective of the study is to assess the relative bioavailability of GTX-104, and the secondary objective of the study is to assess the safety and tolerability of GTX-104, compared to oral capsules of nimodipine, the current standard of care.
Depending on the study protocol, subjects will be randomly assigned in a 1: 1 ratio to one of two treatment sequences: AB or BA, where treatment A and treatment B are as follows:
- Treatment A: GTX-104 Nimodipine IV will be administered by infusion over 72 hours.
- Treatment B: Nimodipine capsules will be administered orally with 240 ml of water at a dose of 60 mg (two 30 mg capsules) every 4 hours for 72 hours.
Safety evaluations will be collected throughout the study and will include treatment-related adverse events, serious adverse events, EKGs, clinical laboratory evaluations, physical examinations, and resting vital signs (including blood pressure). According to the study protocol, healthy subjects will be admitted to the clinical research unit (CRU) the day before administration and will remain domiciled in the RCU for the duration of each study period.
ASA bleeds on the surface of the brain into the subarachnoid space between the brain and the skull, which contains the blood vessels that supply the brain. A main cause of such bleeding is the rupture of an aneurysm. The result is a relatively rare type of stroke that accounts for about one in twenty (5%) strokes and has an incidence of six per 100,000 person-years (Becske, 2018).
Unlike the types of stroke more common in older people, ASH often occurs at a relatively young age, with half of affected patients under the age of 60 (Becske, 2018). Particularly devastating for patients under the age of 45, approximately 10 to 15% of patients with aneurysmal SAH (aHSA) die before reaching hospital (Rinkel, 2016), and those who survive the first few hours after. bleeding are admitted or transferred to tertiary neuro-intensive care centers to manage the high risk of complications, including bleeding recurrence and delayed cerebral ischemia (CDI). Systemic manifestations affecting cardiovascular, pulmonary and renal functions are common and often complicate the management of CDI. About 70% of patients with ASH die or are addicted, and half die within one month of the bleeding. Of those who survive the first month, half remain permanently dependent on someone else to maintain their daily lives (Becske, 2018).
GTX-104 is a novel nanoparticulate formulation of nimodipine in clinical development for IV infusion in patients with ASH. It incorporates surfactant micelles as a drug carrier to solubilize nimodipine. This injectable formulation of nimodipine is composed of a nimodipine base, an effective amount of a hydrophilic surfactant and a pharmaceutically acceptable injection carrier. GTX-104 is an aqueous solution substantially free of organic solvents, so nimodipine is contained in a concentrated solution for injection, suspension, emulsion or complex as a micelle, colloidal particle or inclusion complex, and the formulation is stable and clear. The addressable market in the United States for the GTX-104 is estimated to be approximately $ 300 million based on market research conducted for Grace by Fletcher Spaght.
Acasti is an advanced stage specialty pharmaceutical company with drug delivery technologies and drug candidates for the treatment of rare and orphan diseases. Acasti’s new 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 this could help increase treatment adherence and improve patient outcomes.
Acasti’s three primary clinical assets have each received orphan drug designation from the FDA, giving them seven years of marketing exclusivity after launch in the United States and additional intellectual property protection with over 40 patents granted and pending. Acasti’s main clinical assets target underserved orphan diseases: (i) GTX-104, an intravenous infusion targeting subarachnoid hemorrhage (HSA), 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 skull; (ii) GTX-102, an oral mucosa spray targeting ataxia-telangiectasia (AT), a progressive neurodegenerative genetic disease which mainly affects children, causing severe disability, and for which no treatment currently exists; and (iii) GTX-101, a topical spray, targeting postherpetic neuralgia (NPH), a persistent and often debilitating neuropathic pain caused by nerve damage from the varicella-zoster virus (shingles), which can persist for months, even years. For more information, please visit: https://www.acastipharma.com/en.
Statements in this press release that are not statements of historical or current fact 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 law. 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 from any future results expressed or implied by these forward-looking statements. In addition to statements which explicitly describe these risks and uncertainties, readers are encouraged to consider statements containing the terms “belief”, “belief”, “expect”, “intention”, “anticipate”, “May”, “will”, “plan”, “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 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 the timing of events could differ materially from those anticipated in these forward-looking statements due to various risks and uncertainties, including, without limitation: (i) the success and timing of the study’s regulatory submissions PK transition for GTX -104 and other Acasti preclinical and clinical trials; (ii) regulatory requirements or changes; (iii) changes in clinical trial design 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 which could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with the statements included herein and elsewhere, including the risk factors detailed herein. documents which have been and may be filed by Acasti from time to time with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Acasti assumes 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.
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