Phoenix, Arizona--(Newsfile Corp. - July 7, 2022) - The Stock Day Podcast welcomed Acasti Pharma Inc. (NASDAQ: ACST) ("the Company"), a specialty pharma company with drug delivery technologies and novel drug candidates addressing rare and orphan diseases. CEO of the Company, Jan D'Alvise, joined Stock Day host Sever Copley.
Copley began the interview by asking about one of the Company's lead clinical assets, GTX-104, targeting underserved orphan diseases. D'Alvise elaborated that GTX-104 is a novel intravenous reformulation of nimodipine, which was developed using one of Acasti's drug delivery technologies. Nimodipine is a blood pressure lowering drug currently used specifically to treat patients with Subarachinoid Hemorrhage (SAH), or bleeding on the brain, caused by a burst aneurysm. "By reformulating nimodipine into an IV (intravenous) drug, we believe we will be able to improve the standard of care by allowing physicians to better control blood pressure," explained D'Alvise. She added that better control of blood pressure levels can help to prevent hypotension, vasospasm and other life-threatening complications. "There are about 50,000 people per year in the United States that suffer from a Subarachnoid Hemorrhage (SAH) caused by a burst aneurysm."
"I am very pleased to report that we had very positive results from a recent Pharmacokinetic (PK) study, which showed no statistical difference between our GTX-104 and oral nimodipine in terms of maximum and total exposure over three days," shared D'Alvise. "Based on these results, we plan to proceed with our Phase III study in patients with Subarachnoid Hemorrhage (SAH)," she continued. "One of the most important things we saw with this study is significantly less variability in blood levels compared to the oral form of the drug."
Copley then asked about the Company's additional drug candidates, which are currently under clinical development, GTX-102 and GTX-101. D'Alvise elaborated on Ataxia-telangiectasia (A-T), a progressive, neurodegenerative genetic disease that primarily affects young children, causing severe disability and other complications. "There is really no drug approved for A-T today," said D'Alvise. "We are taking a drug called betamethasone, a marketed glucocorticosteroid, and reformulating it in a clever and proprietary way, which will allow us to deliver it as a concentrated oral spray. GTX-102 could be the first drug approved to treat patients with A-T."
"Based on an early PK study, we estimate that we can get as good or better blood levels at a fraction of the dose as compared to an oral solution form of the drug that is only available in Europe, therefore we believe we may be able to see a reduction of ataxia symptoms without the risk of side effects associated with chronic use of higher doses of a corticosteroid," continued D'Alvise.
"In terms of milestones for 2022, we are about to start a PK study that will allow us to compare blood levels of our oral spray to the injectable form of betamethasone that is available in the U.S.," said D'Alvise. "Those results are expected later this year. If those results are positive, we anticipate being able to immediately start our Phase III program next year."
Copley then asked about the Company's year-end results, as well as the catalysts these results will fund. "We reported that we had $44 million in cash as of the end of March," shared D'Alvise. "Based on our current projections, we expect that cash to last us through next year," she added. "It is enough capital for us to finish our GTX-104 program," said D'Alvise. "It will also allow us to expedite the GTX-102 program, and begin our Phase III study," she said. "We believe it is also going to allow us to complete a couple Phase I studies for GTX-101 and get us into Phase II next year."
To close the interview, D'Alvise shared the Company's unique fast-tracked, lower-risk drug development approach, as well as exciting milestones anticipated in the next year, with the potential to enhance the Company's value. She also encouraged listeners to keep up-to-date on their current and upcoming projects.
To hear the entire interview with Jan D'Alvise, follow the link to the podcast here: https://audioboom.com/posts/8116538-acasti-pharma-inc-discusses-year-end-results-and-clinical-development-progress-with-the-stock-da
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Acasti is a specialty pharma 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, enhanced efficacy, reduced side effects, and more convenient drug delivery-all which could help to increase treatment compliance and improve patient outcomes.
Acasti's three lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provides the assets with seven years of marketing exclusivity post-launch in the United States and have additional intellectual property protection with over 40 granted and pending patents. Acasti's lead clinical assets target underserved orphan diseases: (i) GTX-104, an intravenous infusion targeting Subarachnoid Hemorrhage (SAH), 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; (ii) GTX-102, an oral mucosal spray targeting Ataxia-telangiectasia (A-T), a progressive, neurodegenerative genetic disease that primarily affects children, causing severe disability, and for which no treatment currently exists; and (iii) GTX-101, a topical spray targeting Postherpetic Neuralgia (PHN), a persistent and often debilitating neuropathic pain caused by nerve damage from the varicella zoster virus (shingles), which may persist for months and 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 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 unknown 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 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 and Acasti's other pre-clinical and clinical trials; (ii) regulatory requirements or developments and the outcome of meetings with the FDA; (iii) changes to clinical trial designs and regulatory pathways; (iv) legislative, regulatory, political and economic developments; (v) costs associated with Acasti's clinical trials and (vi) 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 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.
Neither NASDAQ, the 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.
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