Phoenix, Arizona--(Newsfile Corp. - January 17, 2023) - The Stock Day Podcast welcomed Acasti Pharma, Inc. (NASDAQ: ACST), a late-stage 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 pharmaceutical company, and we are focused on developing drugs for rare and orphan diseases," explained D'Alvise. "We are focused on taking drugs that are currently on the market, in many cases for different indications, and repurposing them into orphan diseases where there is a significant unmet need."
"Could you tell us about the recent results you received for the GTX-101 study?," asked Jolly. "We are targeting a disease called post-herpetic neuralgia (PHN), which is very severe and debilitating nerve pain that follows an infection by the shingles virus," explained D'Alvise, adding that the current drugs available for this condition do not typically work very well and can have harsh side effects or different modes of administration. "With GTX-101, we have developed a very novel, topical spray form of bupivacaine," she said. "Our clinical data shows that there is not only a rapid onset of action, but also a sustained release profile."
Expanding on the GTX-101 study, 'We announced the results back in December," continued D'Alvise. "Our results were very exciting. We had very positive results and met all of our primary outcome measures," she shared. "We saw that the bupivacaine from our spray remained in the skin for a long period of time," said D'Alvise. "We also achieved the target blood levels that we were looking for," she added, noting that the Company will now be able to enter a Phase II study in late 2023.
"Could you tell us about the recent results for your GTX-102 study?," asked Jolly. "GTX-102 targets a genetic neurodegenerative disorder that is usually diagnosed in very young children," explained D'Alvise, before elaborating on the significant effects of the disease. "We have developed a concentrated oral spray, which is rapidly absorbed," she said, before discussing the results of the Company's clinical study. "We saw very positive results; we achieved blood levels that were very similar to the injectable version and oral solution of betamethasone," said D'Alvise. "This was great news and will now open the door to moving directly into Phase 3."
"When do you expect to start Phase 3 for GTX-104?," asked Jolly. D'Alvise elaborated on the Company's drug, GTX-104, an intravenous infusion targeting Subarachnoid Hemorrhage (SAH). "For Phase 3, we are only required to show safety equivalent to the orqal form of nimodipine. Based on our clinical data to date, we believe GTX-104 could be more safe than the oral form of the drug," said D'Alvise, noting that the current oral form has an absorption and variability problem. "The phase 3 safety study can be done within fifteen to eighteen months, and we expect to start it in the second quarter," she shared. "This study could be completed by the end of 2024," said D'Alvise. "It is an orphan drug, so we are hopeful the FDA will grant us a fast-track review, which would mean it could be on the market in 2025."
To close the interview, D'Alvise elaborated on the Company's growth as they continue to deliver on their goals, while advancing their pipeline. She also encouraged listeners to keep up-to-date on the Company's current and upcoming programs as they move forward across multiple clinical studies by visiting their website at www.acasti.com.
To hear Jan D'Alvise's entire interview, follow the link to the podcast here: https://audioboom.com/posts/8231079-acasti-pharma-discusses-positive-clinical-study-results-for-gtx-101-and-gtx-102-and-upcoming-phas
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Acasti is a late-stage 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 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 PHN.
For more information, please visit: https://www.acasti.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 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 (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 final results of the PK bridging study for GTX-101; (ii) regulatory requirements or developments; (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 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. 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.
Chief Executive Officer
Lytham Partners, LLC
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