Lexaria Unveils Extensive Planned 2024 GLP-1 Study Program
- None.
- None.
Insights
The announcement of Lexaria Bioscience Corp's extensive research program on DehydraTECH technology for GLP-1 drugs has considerable implications for the pharmaceutical industry. The focus on improving oral delivery of diabetes medication is a significant area of innovation, given the discomfort and inconvenience associated with injectable therapies. The potential shift to oral administration could disrupt the current market, which is dominated by injectable GLP-1 drugs. If Lexaria's technology proves successful, it could lead to partnerships with larger pharmaceutical companies seeking to integrate this technology into their existing or pipeline products.
Moreover, the revenue figures for the GLP-1 drugs mentioned hint at the substantial market opportunity for Lexaria. The success of these studies could result in significant stock market movement, particularly if Lexaria secures partnerships or licensing deals. However, investors should be cautious, as the research is still in early stages and any commercial application will require substantial further testing, regulatory approval and market acceptance.
The pharmacokinetic ('PK') profile of a drug is critical in determining its efficacy and safety. Lexaria's pilot study suggesting enhanced PK performance of DehydraTECH-enhanced semaglutide is noteworthy. If subsequent studies validate these findings, it could lead to improved patient outcomes due to better drug absorption and potentially fewer gastrointestinal side effects, a common issue with current GLP-1 therapies. The inclusion of DehydraTECH-CBD in the studies is also intriguing, as it suggests a possible synergistic effect on glycemic control and weight loss, which could be a differentiating factor in a crowded market.
It is important to note that these studies are non-registrational, meaning they are not intended to support a New Drug Application (NDA). Nonetheless, the data generated could be invaluable for future development and registrational trials. The long-term stability testing also underscores the company's commitment to ensuring product quality, which is a critical aspect for eventual commercialization.
Lexaria's announcement of upcoming studies is a strategic move to boost investor confidence and potentially attract commercial partners. The reference to billions of dollars of revenue generated by GLP-1 drugs underscores the financial potential of the DehydraTECH technology. However, investors should be aware of the inherent risks associated with biopharmaceutical research and development. The company's note about the need for sufficient funding and the conditional nature of study dates serves as a reminder that financial projections should account for possible delays and additional capital requirements.
Furthermore, the stock market often reacts to updates from biotech companies' clinical trials. Positive interim results could lead to stock appreciation, while any setbacks might have the opposite effect. Long-term success will depend on the technology's efficacy, safety and market penetration, which will only be clear after extensive testing and regulatory scrutiny.
Extensive work program designed to support commercial discussions.
KELOWNA, BC / ACCESSWIRE / January 16, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX) & (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces a comprehensive planned applied research program to thoroughly evaluate DehydraTECH for the improved delivery of GLP-1 drugs, designed to support prospective commercial partnering with the global pharmaceutical companies.
In a recent human pilot study with 7 volunteers, Lexaria demonstrated superior pharmacokinetic ("PK") oral delivery performance of the DehydraTECH-enhanced glucagon-like peptide-1 ("GLP-1") drug semaglutide available commercially in the branded product Rybelsus®. The results were sufficiently positive to encourage much more thorough and expanded investigation.
The objective of the new planned studies is to help determine the commercial applicability of DehydraTECH to at least three GLP-1 drugs (semaglutide, liraglutide, and tirzepatide) which together produced billions of dollars of revenue to their owners, as reported in their most recent financial statements. The new planned studies to be undertaken are as follows:
Chronic Dosing Animal Study
Targeted start March/April, 2024. This will be an obese rat diabetic-conditioned study similar to a previous Lexaria study, with approximately 12 study arms and 6-10 animals per arm. The study is expected to run for 12 weeks to allow time to study weight loss, PK, and blood sugar control over time, followed by full data analysis and reporting. Varied DehydraTECH formulations of semaglutide and liraglutide, alone and together with DehydraTECH-CBD, will be evaluated. We also expect to be evaluating DehydraTECH-processed semaglutide with and without the salcaprozate sodium "SNAC" technology currently found within Rybelsus® tablets. We will be collecting and reporting interim results prior to the end of the study.
Human Pilot Study #2
Targeted start March/April, 2024. This human pilot study in up to 8 healthy volunteers, will study a single dose of oral ingested DehydraTECH-semaglutide capsules in a similar design to Human Pilot Study #1. We also intend to study an oral dissolvable DehydraTECH-semaglutide tablet formulation (dissolvable into sublingual/buccal tissue) to determine whether GLP-1 drug absorption via this route is effective and well tolerated as an alternative to the conventional oral ingestible route which often presents with gastrointestinal side effect issues. Tolerability, PK, and blood sugar control will all be evaluated. The DehydraTECH compositions for this study will be compound-formulated using commercially available Rybelsus tablets as the semaglutide input material.
Human Pilot Study #3
Targeted start in May/June, 2024. This human pilot study in up to 8 healthy human volunteers will study a single dose of oral ingested DehydraTECH-tirzepatide capsules (to be compound-formulated using Zepbound® by Eli Lilly) to evaluate tolerability, PK, and blood sugar. Zepbound® is currently administered by injection only and will be used as the tirzepatide input material for production of the DehydraTECH-tirzepatide capsules to be studied. Importantly, this study will evaluate DehydraTECH effectiveness in humans with a dual action GLP-1 + glucose-dependent insulintropic peptide (aka "GIP") drug while also doing so without the SNAC ingredient found in the Rybelsus® semaglutide composition from Human Pilot Studies 1 and 2.
Chronic Dosing Human Study
Targeted start Q3, 2024. This chronic human study in 70 to 90 pre-diabetic and type-2 diabetic human patients will dose daily using oral DehydraTECH capsules for 12 weeks and will evaluate tolerability, PK, weight loss, blood sugar levels and more. The primary goal of this study will be to compare DehydraTECH-processed semaglutide capsules (from compound-formulated Rybelsus® tablets as the semaglutide input material) to DehydraTECH-CBD capsules alone - and together in combination - relative to a placebo control over an extended period of time. Inclusion of DehydraTECH-CBD in this study will be undertaken to determine if the improvements in glycemic control and weight loss witnessed in Lexaria's previous animal study are evidenced in humans.
Long Term Stability Testing
Lexaria plans to study the chemical and microbiological purity and stability of select DehydraTECH compositions that it prepares for the above planned upcoming animal and human studies over an extended duration of 6-12 months. Along with improved tolerability, PK and efficacy performance, long term stability is crucial if oral variants of GLP-1 drugs are to be seriously considered as replacements for currently injectable versions of these drugs.
All the programs described above are subject to change or substitution; dates are targets only; and some are subject to raising sufficient funds. All human studies will be investigator-initiated non-registrational studies and will require certain approvals before beginning. All studies will utilize third-party laboratories.
Lexaria is excited to be embarking on this expanded GLP-1 investigatory program at a time that there is a clear medical and market need for improved performance and broader oral delivery of this class of drugs. Lexaria will continue to provide further updates on this GLP-1 study program as it progresses and more details become available.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 38 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.
CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the Company relating to the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
ir@lexariabioscience.com
Phone: 250-765-6424, ext 202
SOURCE: Lexaria Bioscience Corp.
View the original press release on accesswire.com
FAQ
What is the purpose of Lexaria's extensive planned research program?
What drugs will be evaluated in the planned studies?
What are the objectives of the new planned studies?
What is the goal of the chronic dosing animal study?
What is the purpose of the long term stability testing?
