Phoenix, Arizona--(Newsfile Corp. - February 22, 2022) - The Stock Day Podcast welcomed Acasti Pharma Inc. (NASDAQ: ACST) ("the Company"), a specialty pharma company with drug delivery technologies and drug candidates addressing rare and orphan diseases. CEO of the Company, Jan D'Alvise, joined Stock Day host Everett Jolly.
Jolly began the interview by asking about the Company's background and current projects. "Acasti is a specialty Pharma company," explained D'Alvise. "We have developed a range of drug delivery technologies that we are applying to marketed drugs," she continued. "We are taking drugs that are already approved and on the market, in most cases for different indications, and we're applying our unique drug delivery technologies to improve how the drug works in patients, as well as the safety and efficacy, to hopefully improve patient outcomes."
"Your company focuses on orphan diseases; what qualifies as an orphan disease?", asked Jolly. "The FDA's definition is a disease or condition where there are roughly 200,000 patients or less that are diagnosed," said D'Alvise, before elaborating on the orphan diseases the Company is currently addressing, including Subarachnoid Hemorrhage (SAH).
Jolly then asked about the Company's commercialization strategy for their intravenous infusion, GTX-104, which targets SAH. "It will be a direct sale," said D'Alvise. "We think we can reach the market fairly quickly because the largest centers will be working with us to do our Phase III trial, which will start later this year," she shared. "We hope if we have good results, they will become early adopters of the product."
"What about your other two drugs in clinical development right now?", asked Jolly. D'Alvise then expanded on GTX-102, an oral mucosal spray targeting Ataxia-Telangiectasia (A-T), a disease which is typically diagnosed in young children.
The conversation then turned to the Company's completion of a merger with Grace Therapeutics, Inc. "We narrowed in on Grace because of the rich pipeline of products addressing truly important unmet needs in these various diseases, and the drug assets they had were fairly far along in development," said D'Alvise. "We knew with a minimum amount of capital we could complete development and get rapid approval," she said. "All of these drugs have qualified and have received orphan drug designation from the FDA."
"What major milestones and catalysts do you expect over the next two to three quarters?", asked Jolly. "We are just finishing a PK study for our lead program, GTX-104," said D'Alvise. "This is a very pivotal study, and we expect to report those results in the second quarter," she added. "Assuming positive results, his PK study will enable us to go directly into Phase III."
"With GTX-102 for Ataxia-telangiectasia (A-T), we are going to start our Phase II this quarter and we will finish that by the end of this year, and then we plan to start our Phase III program early next year," said D'Alvise. "We didn't get a chance to talk about GTX-101, which is a topical spray analgesic for Postherpetic Neuralgia (PHN)," she shared. "We are doing a Phase I study now and should be able to move into a Phase II study by the end of the year."
To close the interview, D'Alvise encouraged listeners to keep up-to-date on the Company's current and upcoming projects as they continue to advance in the orphan disease space.
To hear the entire interview with Jan D'Alvise, follow the link to the podcast here: https://audioboom.com/posts/8035884-acasti-pharma-inc-ceo-jan-d-alvise-is-featured-on-the-stock-day-podcast.
About Acasti Pharma Inc.
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 U.S. FDA, which provide the assets with 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 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," "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 PK bridging study for GTX-104 and Acasti's other pre-clinical and clinical trials; (ii) the final outcome of the PK bridging study for GTX-104, including the potential of GTX-104 to provide improved bioavailability and lower intra-subject variability compared to oral capsules; (iii) regulatory requirements or developments and the outcome of meetings with the FDA; (iv) changes to clinical trial designs and regulatory pathways; (v) legislative, regulatory, political and economic developments; (vi) costs associated with Acasti's clinical trials and (vii) 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 may be 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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