Last week, Lexaria Bioscience Corp. (Nasdaq: LEXX) reported additional findings from its human clinical study HYPER-H21-4 which demonstrated a potentially novel mechanism of action of its patented DehydraTECH-processed cannabidiol (CBD) capsule formulation in reducing blood pressure (BP).
The Food and Drug Administration (FDA) has laid out clear guidelines for sponsors who seek to develop new anti-hypertensive drugs, specifically defining the need for medications that offer complementary modes of action.
Based on the peer-reviewed and published results (published in Biomedicine and Pharmacotherapy), Lexaria believes that DehydraTECH-CBD may qualify within these FDA guidelines. We believe our readers should be aware of the following data points:
- Lexaria previously announced that the primary efficacy and safety objectives of the study were successfully achieved, with resting BP significantly reduced in hypertensive patients, and sustained over the full 5-weeks of dosing (with zero serious adverse events being reported).
- Ongoing analyses of data from the study have revealed modulation of a circulating compound called catestatin in the patients. Catestatin is a multifunctional peptide that is known to have inhibitory effects on the sympathetic nervous system in the pathophysiology of hypertension.
- These analyses revealed that administration of DehydraTECH-CBD resulted in a statistically significant reduction in average baseline serum catestatin concentrations after 5 weeks of dosing. There were no statistically significant reductions in catestatin concentrations in the placebo group.
- As previously reported, mean arterial pressure also dropped significantly following the 5-week period of DehydraTECH-CBD dosing. Once again, there were no statistically significant reductions in the placebo group.
What Makes The Data Significant
Based on the latest study results, the data could imply that the antihypertensive effects of DehydraTECH-CBD may be explained, at least in part, by its interaction with the sympatho-chromaffin system via catestatin modulation.
The results of the study suggest a potentially unique mechanistic benefit upon cardiovascular regulation with DehydraTECH-CBD treatment that has not previously been demonstrated (to the company’s knowledge) with testing of CBD for blood pressure reduction.
The results from the study indicate that Lexaria’s DehydraTECH-CBD has the potential to offer complementary and additive BP reduction benefits on top of any degree of improvements the standard of care medications provided.
What Are The Next Steps?
If Lexaria can bring DehydraTECH-CBD as an approved hypertension treatment to the market, the technology could prove to be a significant value enhancer for the business. There is a clear medical and market need for alternative anti-hypertensive therapies like DehydraTECH-CBD and we believe the market is not assigning enough value to this part of the business.
Currently, Lexaria is conducting more study endpoint analyses and will be providing updates as they become available. We are favorable with the updates that have been provided thus far and believe the positive data trend is underappreciated by the market.
If you are interested in learning more about Lexaria Bioscience, please send an email to support@onthebids.com with the subject “Lexaria Bioscience” to be added to our distribution list.
Company Relationship Disclosure
OTB is responsible for the OTB opinions provided in this disclosure except all sources or information provided by other parties were not verified or authenticated and OTB does not undertake to confirm or substantiate or be responsible for such information provided by other parties.
Any Content posted regarding a Profiled Issuer is not a solicitation or recommendation to buy, sell or hold securities. We cannot and do not assess, verify or guarantee the adequacy, accuracy or completeness of any information, the suitability or profitability of any particular investment, or the potential value of any investment or informational source. All information should be independently verified. We are not responsible for errors or omissions in our publications, and any opinions expressed are subject to change, without notice. We do not, nor are we under any obligation to undertake due diligence or investigation or authenticate and verify whatsoever regarding Profiled Issuers or any Content posted in relation thereto and we do not receive any verification from the Profiled Issuer regarding the Content we disseminate. Similarly, while we endeavor to facilitate the provision of quality information, we are not responsible for any loss or damages caused or alleged to have been caused by its use nor verify or authenticate or update such information.
Pursuant to an agreement between Spotlight Media and Lexaria Bioscience we have been hired for a period of 30 days beginning February 9, 2023 and ending March 9, 2023 to publicly disseminate information about Lexaria Bioscience including on the Website and other media including Facebook and Twitter. We are being paid $2,000 per month by Lexaria Bioscience and were paid “ZERO” shares of unrestricted or restricted common shares. We plan to sell the “ZERO” shares of Lexaria Bioscience that we hold during the time the Website and/or Facebook and Twitter Information recommends that investors or visitors to the website purchase without further notice to you. We may buy or sell additional shares of Lexaria Bioscience in the open market at any time, including before, during or after the Website and Information, provide public dissemination of favorable Information.
This article contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs regarding future performance are “forward-looking statements”. Forward-looking statements can be identified by the use of words such as “expects”, “does not expect”, “is expected”, “believes”, “intends”, “anticipates”, “does not anticipate”, “believes” or variations of these words, expressions or statements, that certain actions, events or results “may”, “could”, “would”, “might” or “will be” taken, will occur or will be realized. Such forward-looking statements involve risks, uncertainties and other known and unknown factors that could cause actual results, events or developments to differ materially from the results, events or developments expected and expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, dependence on obtaining and maintaining regulatory approvals, including the acquisition and renewal of federal, provincial, state, municipal, local or other licenses, and any inability to obtain all necessary government authorizations, licenses and permits to operate and expand the Company’s facilities; regulatory or policy changes such as changes in applicable laws and regulations, including federal, state and provincial legalization, due to fluctuations in public opinion, industry perception of integrative mental health, including the use of psychedelic-assisted therapy, delays or inefficiencies or any other reason; any other factor or development likely to hamper the growth of the market; the Company’s limited operating and profitability track record; dependence on management; the Company’s need for additional financing and the effects of financial market conditions and other factors on the availability of capital; competition, including that of more established and better funded competitors; the impact of the Russia-Ukraine conflict on the global economy; the continued impact of the COVID-19 pandemic; and the need to build and maintain alliances and partnerships, including with research and development companies, customers and suppliers. These factors should be carefully considered, and readers are cautioned not to place undue reliance on forward-looking statements. Despite the Company’s efforts to identify the main risk factors that could cause actual measures, events or results to differ materially from those described in forward-looking statements, other risk factors may cause measures, events or developments to materially differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company does not undertake to revise forward-looking statements, even if new information becomes available as a result of future events, new facts or any other reason, except as required by applicable laws
