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Oral GLP-1 going to OTC could really open up the market for LEXX to get product up and running sooner than ever! The huge interest across the board is super positive. Thanks for posting this.
Next frontier in anti-obesity landscape: oral GLP-1s with potential OTC switch
The race to develop oral obesity drugs is heating up. Eli Lilly (LLY) and Novo Nordisk (NVO), makers of the highly popular injectable GLP-1 class of weight loss drugs, as well as potential new entrants Pfizer (PFE) and Roche (OTCQX:RHHBY), are all in the fray.
Shortcomings of injectables have made oral GLP-1s a hotly pursued goal in the anti-obesity space. However, Oppenheimer went a step further, arguing in a research note on Wednesday that a potential switch to their over-the-counter status would be an added advantage.
“In an intensely competitive obesity landscape, Rx to OTC could be a highly differentiated, valuable life-cycle management strategy to preserve substantial brand equity well beyond patent expiry,” Oppenheimer analyst Jay Olson argued.
His comments followed a selloff in Novo Nordisk (NVO) shares on Friday after the Danish drugmaker said its cannabinoid receptor-targeting obesity pill raised concerns over neuropsychiatric side effects in a mid-stage study.
However, Olson rules out safety concerns for GLP-1s and predicts a future Rx-to-OTC switch for an oral GLP-1, attributing the current black box warning approved for the drug class to pancreatitis linked to first-generation GLP-1s such as exenatide but not newer GLP-1s.
Oppenheimer pointed to Viking Therapeutics (VKTX) oral weight loss candidate VK2735 as the best-positioned candidate to receive the Rx-to-OTC switch. The dual agonist of gut hormone receptors GLP-1 and GIP is set for an early-stage readout at Obesity Week in early November.
“We believe oral VK2735 is a potential candidate for OTC status based on existing clinical data and look forward to Obesity Week updates,” Olson wrote with an Outperform recommendation and a 12-18 month target of $138 per share.
Masterbidder -TY _YES the RS
Don’t forget the RS
If compensation were paid on results -- he should pay LEXXY. Bunka has been overpaid and uinder performed. $30k a month, stock options etc. (wonder if he till gets 2% of the sale of a division?--hope not). Deals done - not so much. The Altria deal -- killed the nicotine division. PPS an embarrassment. Cost and success of putting us on the NAS?. Bunka - God Bless, good bye and imho -- good riddance. GLTA, especially our new CEO.
If compensation were paid on results -- he should pay LEXXY. Bunka has been overpaid and uinder performed. $30k a month, stock options etc. (wonder if he till gets 2% of the sale of a division?--hope not). Deals done - not so much. The Altria deal -- killed the nicotine division. PPS an embarrassment. Cost and success of putting us on the NAS?. Bunka - God Bless, good bye and imho -- good riddance. GLTA, especially our new CEO.
Is Lexaria's settlement with CEO Bunka excessive?
https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com/ugd/449582_3c01a6c7c1fd4ee98605fe572000b7a4.pdf
Expecting 20 to 30 pps in next 3-5 months
The PharmaCo folks will start accumulating in 2-3 months time
Feels like something is brewing. Today could be a big day.
I am glad to see the change in CEO, bodes well for the future IMO.
All the best,
Knife
Yes, but what molecules? And what conditions are they thinking of treating? It could cover all conditions and formulations or just one. Just some of the many unanswered questions.
Where's the beef (moolah)?
Bunka is out as CEO, replaced by Christopher. To stay on as strategic advisor and board member. Wow!
I think you are bang on that it’s a transparency release to avoid future complaints from shareholders that sell and weren’t told about such an arrangement. If this was a nothing burger I would have expected greater length and excitement trying to make it sound better than it is. This release was so brief and lacked any detail that it sure smells like it was written by lawyers at the PharmaCo only to let them release the bare minimum. Given the studies to date have all focused on two GLP molecules I know who my first guess is.
Also note that the exclusivity is only for the molecules to be further tested jointly so this doesn’t prevent any other collaboration with any other company on other molecules that Dehydratech is found to work on.
This is nothing but positive IMO.
Seems like just a "cover your ass" transparency PR in case after a deal is made folks wonder why nothing was said about it earlier. Could be a nothing burger or a feast...time will tell.
No details at all, so we have no idea what it really means.
Yes, it was a good day. It looks like we're up against an area of strong resistance at around the $4.25 to 4.40 area. Tuesday should be an interesting day, if we can break through here on strong volume the upside potential is great.
Nice move on volume today.
Good times,
Knife
Yep, someone's filling their boots!
Interesting. "If I could I would". I'm still riding the current ripple and hanging until we get the wave. A matter of time. Thanks for the update
Special Report: The market is missing the boat on Lexaria. Here’s why
https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com/ugd/449582_58b5c89f511a4afdb01d57bd179db8ab.pdf
https://www.cnn.com/2024/08/20/health/tirzepatide-diabetes-lilly-trial/index.html
It just needs an oral delivery system!
around 1:15pm 200k shares bought/sold in a matter of minutes?
LEXARIA BIOSCIENCE CORP.
Filed by
BOOS WAYNE W
FORM SC 13D/A
(Amended Statement of Beneficial Ownership)
Filed 08/06/24
https://www.otcmarkets.com/filing/conv_pdf?id=17734916&guid=7tO-kFxAigIjJth
Boos Wayne W - Activist 13D/13G Filings
https://fintel.io/i13d/boos-wayne-w
Just bring a big fat cheque and you can corner the market Novo 😉
https://www.ft.com/content/2ea93480-f6dc-4714-aeaa-036427eafe53
Does anyone have access to Ted’s report a few weeks ago where Bunka laid out a possible timeline for news? The library does not seem to be accessible any longer and I would be curious to see how we are stacking up against it.
Special Report: Lexaria explains GLP-1 test results that led to +25% gain last week
https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com/ugd/449582_537c8f1a7a1243d0a809ebfd4627e65b.pdf
So much potential for Lexaria. This next 6-12 months is going to be fun I think...
https://www.biospace.com/drug-development/beyond-weight-loss-novo-and-lilly-look-to-expand-their-glp-1-pipelines
Positive Interim Body Weight Results from Lexaria's Diabetes Animal Study
(via TheNewswire)
Lexaria Bioscience Corp.
DehydraTECH appears to work with a second GLP-1 drug – liraglutide
DehydraTECH appears to be working with semaglutide both with and without SNAC technology
DehydraTECH-CBD is showing strong apparent performance relative to GLP-1
Dosing in the final four study arms has now begun
Kelowna, British Columbia – TheNewswire - July 17, 2024 – Lexaria Bioscience Corp. (Nasdaq: LEXX & LEXXW) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms announces that interim results from the first four weeks of dosing in its ongoing diabetes animal study WEIGHT-A24-1 (the “Study”) have been received and have already produced several noteworthy findings.
Unlimited food and water has been provided to the animals for the entire duration of the Study. During the initial acclimation phase of 34 days before the beginning of dosing, the animals gained 10.9% body weight on average. During the subsequent 28 days of DehydraTECH-processed drug therapy dosing, all test articles showed either a stark decrease in the rate of body weight gain or, in select cases, the beginning of body weight reduction. DehydraTECH-CBD formulation 3 (“CBD3”) and DehydraTECH-liraglutide have produced the largest weight loss results thus far of -1.50% and -1.58%, respectively. Of note, only in Study arms A, B, C, and E did any individual animals lose 5.0% or more body weight during these first 28 days of treatment. An additional 56 days of dosing remains across all treatment groups.
Animal Weights (grams)
DehydraTECH Groups
Arrival in Lab
End of Acclimation Period
% Change to End of Acclimation
End of 28 Days of Dosing
% Change to Day 28
A: CBD1
386.0
427.9
+10.9%
432.6
+0.96%
B: CBD2
360.6
394.6
+9.4%
393.3
-0.59%
C: CBD3
375.5
416.0
+10.8%
408.8
-1.50%
D: CBD4
377.2
431.2
+14.3%
431.7
+0.32%
E: Rybelsus1
365.1
394.9
+8.2%
394.6
+0.07%
F: Rybelsus2
364.5
406.2
+11.4%
409.1
+0.72%
G: Semaglutide
352.7
394.2
+11.8%
394.8
+0.16%
H: Liraglutide
354.6
392.2
+10.6%
385.7
-1.58%
Average
367.0
407.1
+10.9%
406.3
-0.18%
Notes
-Weights shown are average of six animals per group.
- Groups A through D were varying DehydraTECH-CBD compositions
- Groups E and F were reformulated Rybelsus® compositions including DehydraTECH and the sodium salcaprozate (“SNAC”) technology
- Groups G and H used pure GLP-1 drugs (semaglutide and liraglutide respectively) without SNAC inclusion
This is the first time that DehydraTECH processing was applied to the GLP-1 drug liraglutide, and it is encouraging to witness its relative outperformance. Although liraglutide was administered as an oral DehydraTECH-enabled dose in this Study, it is currently only sold and prescribed as a subcutaneous injection (see below for more context). Liraglutide is currently available commercially by Novo Nordisk® sold under the brand names Victoza® and Saxenda®, but the related patents have begun to expire and open the door to new competitors. For example, Teva Pharmaceutical Industries Ltd® recently launched the first generic injectable version of this GLP-1 drug.
Study arm G is the first time that pure semaglutide was tested with DehydraTECH processing without the SNAC technology found within the Rybelsus® tablets. It is of interest that it has, so far, apparently performed nearly identically in body weight gain attenuation to Study arm E which is the best performing DehydraTECH-processed reformulated Rybelsus® composition that includes the SNAC technology.
Click Image To View Full Size
Another important objective has now been reached in evaluating the results of the first 28 days of dosing among the first eight Study arms that, together, constitute Cohort 1 of the Study: Performance superiority has been observed among the various formulations, allowing the Study team to select the best performers for inclusion in the subsequent Cohort 2 Study work. Dosing in those final four Study arms that constitute Cohort 2 of the Study has begun and is expected to be completed in mid-October.
Those final four Study arms include a positive control arm (commercially available Rybelsus®) and a placebo arm, as well as a combined DehydraTECH-semaglutide with DehydraTECH-CBD arm (Groups C + E), and a combined DehydraTECH-liraglutide with DehydraTECH-CBD arm (Groups C + H).
In all cases and as per design in an exploratory, directionally informative Study of this nature, animal populations were not intended to be large enough to necessarily evidence statistical significance, and readers are reminded that these data are indicative only of apparent trends that have not been analysed statistically. Blood glucose data for the first four weeks of dosing has also been received, is being processed, and will be released soon. Pharmacokinetic (“PK”) data for the first four weeks has not arrived yet and will be released when available.
Brain absorption data can only be collected at the end of the 12-week study and will also be released when available. Readers are encouraged to review our May 17, 2024 press release that provides a thorough explanation of the comprehensive Study design and rationale, including why possible enhancement of brain absorption is believed to be of potential significance.
About Liraglutide
Liraglutide is owned by Novo Nordisk® and sold under the Victoza® and Saxena® brands which generated $1.6 billion in combined revenue in 2022. Liraglutide is currently administered only by injection, after attempts to utilize the SNAC technology found in semaglutide (and sold as the oral tablet Rybelsus®) failed to deliver sufficient performance to enable an oral form factor.
Previous investigators reported that “the absorption enhancing action of SNAC is thought to be highly dependent on the specific agent it is enhancing, which means that carefully tailored co-formulation is required rather than co-administration. The structure of liraglutide (a structurally distinct analog of GLP-1RA) was found to be unfavorable for co-formulation with SNAC on account of its stronger membrane-binding properties, which reduced transcellular passage, as well as its greater tendency to oligomerize, which countered the monomerizing effects of SNAC. In a preclinical study, plasma exposure was significantly higher for semaglutide than liraglutide after oral dosing with SNAC.”
About the Study
Study WEIGHT-A24-1 is underway using diabetic, pre-conditioned Zucker rats. Each arm of the Study is expected to be dosed for a 12-week period following the initial acclimation period. During the Study, over 1,500 blood plasma samples will be collected from the total rat population of 72 animals for purposes of detailed PK drug delivery analyses. Body weight and blood glucose readings were taken prior to Study start continuing at regular intervals during and at conclusion of the dosing period. Upon completion of the Study, brain tissue will be analysed to help determine whether DehydraTECH processing results in higher brain absorption than non-DehydraTECH arms, as Lexaria has evidenced numerous times in previous similar animal studies. The Study will also include a comprehensive battery of liver and kidney function testing and blood chemistry analyses. LC-MS/MS and other techniques will be used to analyse samples.
About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria’s patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 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 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
SHAWKING - WORTH SAYING AGAIN - THANK YOU!
Strategic growth plan execution underway.
Kelowna, British Columbia – July 16, 2024 – TheNewswire – Lexaria Bioscience Corp. (Nasdaq: LEXX & LEXXW) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms announces plans for strategic growth.
“Lexaria has certain initiatives underway that are increasing confidence in our medium-term and longer-term strategies,” said Chris Bunka, Chief Executive Officer of Lexaria Bioscience Corp. “As a result of the success we are experiencing and the continued success we are anticipating, we will be implementing a number of strategic steps in the weeks and months to come.”
Lexaria will be expanding its management team this summer as it prepares for the greater workload of multiple projects and initiatives. The first step is appointing Nelson Cabatuan as our consulting Chief Strategic Financial Advisor, in order to maximize his skills in the fields of corporate finance and strategic industry relationships and opportunities. Nelson is resigning from his current role as Chief Financial Officer (CFO) in order to better focus on the strategic opportunities afforded to the Company outside of typical accounting tasks. Our new CFO will be appointed and announced in due course.
The Company is also in the conceptual design stages of additional R&D projects related to additional GLP-1 molecules of interest, beyond those previously disclosed. Announcements about additional R&D studies may be made over the next several months. Finally, Lexaria is closely examining its Phase 1b hypertension study, that has already received clearance to proceed from the FDA, for more concrete steps to launch that study, subject to funding, as soon as possible.
About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria’s patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 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 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
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Lexaria Bioscience Corp. (CSE:LXX; OTCQX:LXRP) has developed and out-licenses its disruptive and cost-effective DehydraTECH™ technology that promotes healthier administration methods, lower overall dosing and higher effectiveness of ingestible drugs and other beneficial molecules.
Lexaria’s DehydraTECHTM delivery technology is protected by a robust suite of patents granted or pending worldwide and is proven effective in multiple international studies in greatly assisting rapidity and quantity of absorption of a range of lipophilic (i.e., fat-soluble), bioactive molecules. By significantly enhancing the performance and experience with oral ingestion, Lexaria’s DehydraTECH delivery technology offers a viable and often healthier alternative to other delivery methods for bioactive substances in widespread use today such as inhalational delivery through smoking.
Lexaria’s patented technology, DehydraTECH™ delivers these important benefits:
Eliminates the strong tastes/odors of lipophilic compounds, without the need for unwanted sugar or sweeteners
Effects are felt within 15-20 min vs. 60-120 min.
Initial testing indirectly evidences DehydraTECH may deliver ingested molecules through the lymphatic system instead of being subject to immediate “first pass” liver exposure, potentially mitigating unwanted side effects and reducing liver biotransformation.
Bio-absorption increases up to 3 – 10X, to equate or exceed that of other routes of administration like inhalational delivery.
Lexaria’s DehydraTECH™ is designed specifically for formulating and delivering lipophilic (i.e. fat-soluble) drug payloads. It is patented or patent-pending for use with a broad range of bioactive molecules, including but not limited to:
Lexaria Bioscience Corp. (“Lexaria”) has formed the Lexaria Nicotine Corp. as its exclusive worldwide nicotine business unit. More than 89% of all nicotine that is consumed worldwide is delivered through smoking cigarettes. Approximately 6,000,000 deaths per year around the world are attributed primarily to the delivery of nicotine through the act of smoking according to the Centers for Disease Control and Prevention. Of note: “…it is primarily the toxins and carcinogens in tobacco smoke – not the nicotine – that cause illness and death.” (U.K. National Institute for Health and Care Excellence [NICE]). As many as 69% of U.S. adult smokers want to quit smoking and 43% of US adult smokers have attempted to quit in any twelve-month period. Lexaria postulates that delivery of nicotine to satisfy current demand, utilizing our patented DehydraTECH technology in common food and consumer product formats, could shift demand away from smoking cigarettes. However, ingestion of nicotine is challenging because it is poorly tolerated by the human gastrointestinal system and then significantly metabolized by the liver, thereby diminishing its overall effectiveness through edibles. Lexaria’s DehydraTECH technology offers a means to formulate ingestible product formats of nicotine and/or its analogs with higher bioavailability performance possibilities due to the benefits of our technology.
Lexaria is developing a patent suite with supporting intellectual property in the pharmaceutical sector that will supply significant long-term strategic growth potential. Lexaria Pharmaceutical Corp. is the 100%-owned subsidiary that has obtained exclusive worldwide rights to Lexaria’s patent portfolio related to pharmaceutical applications. Currently within this business unit resides the IP for Non-Steroidal Anti-Inflammatories (NSAIDs), Vitamins, hormone treatments utilizing estrogen or testosterone, phosphodiesterase inhibitors (PDE5). Additional molecules of interest could be added to this unit over time.
According to Statista.com, the global pharma industry was worth $1,105 billion in 2016, and the US pharma industry alone spent over $71 billion in 2017 on R&D: a larger R&D expenditure than the entire gross revenues of many other business sectors.. Lexaria Pharmaceutical Corp. is implementing a strategy of reinforcing its IP-suite to sufficient degree to begin partnering within this dynamic industry.
The Lexaria Hemp Co. holds exclusive global rights to the Lexaria patent portfolio related to hemp-based applications. Lexaria’s DehydraTECH technology is designed to deliver functional ingredients within hemp in oral product formats with significantly enhanced palatability, speed of effectiveness and potency as a viable and healthier alternative to conventional inhalational (i.e. smoking or vaping) administration practices. Extensively evaluated through invivo, invitro, and human clinical studies, one of the most extensive databases in the world has been collected by Lexaria related to hemp-based ingredients empowered with our DehydraTECH technology. In 2018, the World Anti Doping Agency (WADA) for the first time ever exempted cannabidiol from hemp from its list of restricted substances on its International Standards Prohibited List of substances.
Lexaria CanPharm Corp, a Canadian corporation, owns exclusive global rights to Lexaria’s intellectual property as it is applied to psychotropic bioactive molecules that act upon human CB1 and CB2 receptors in those areas of the world where it is permissible to do so. Substances that act upon these receptors and systems in the human body that affect pain, inflammation, anxiety and depression, and have also been shown to have utility against cancer and neurodegenerative conditions. Lexaria’s ground-breaking 2018 research that proved many-fold improvements in delivering an active ingredient across the blood-brain-barrier could have disruptive potential within this business sector as well as all others where Lexaria is active.
The safety and effectiveness of Lexaria’s DehydraTECH™ technology has been studied in a series of controlled and well designed in vitro and in vivo human focus studies, examining factors such as total bioabsorption directly and indirectly through surrogate biomarkers, time to onset of effectiveness, flavor appeal and quality of effectiveness. Studies to-date have focused on cannabinoid applications where Lexaria is most advanced commercially, although research is underway for the other bioactive compounds named in Lexaria’s patent portfolio and described under Commercial Applications.
Pre-Clinical Research into Lexaria’s DehydraTECH™
An in vitro absorption study was performed to assess unidirectional CBD permeability using a human epi-intestinal tissue model with various formulations in the presence of simulated intestinal fluid. The study was designed to, as closely as possible, mimic intestinal absorption as it would occur in a live subject. Samples of Lexaria’s commercially available CBD-fortified ViPova™ black tea were administered in the model compared with concentration-matched CBD control preparations that lacked Lexaria’s patented formulation and process enhancements. The study showed as much as a 499% improvement, on average, in intestinal tissue permeability with the ViPova™ black tea formulation relative to a concentration-matched CBD control preparation without any Lexaria technology enhancements. The study also showed a 325% improvement, on average, in intestinal tissue permeability comparing the ViPova™ black tea preparation to a concentration-matched CBD control preparation that utilized Lexaria`s dehydration synthesis processing methodology but lacked its fatty acid ingredient incorporation, demonstrating the power of the Lexaria technology as a whole (see Figure 1).
Following this study, a series of independent, well designed, well controlled human focus studies were undertaken corroborating Lexaria’s in vitro performance findings. A study in healthy volunteers (n=6) suggested as much as a 5-10X increase in CBD absorption, which was assessed indirectly through measurement of the increase in salivary nitric oxide as a directly proportional surrogate biomarker, with onset of action in as little as 15-30 minutes. In all cases, the maximum increased level of salivary nitric oxide remained evident at the 60-minute end period of this particular test. Further testing is required to determine the full duration of elevated nitric oxide levels.
Thereafter, a blinded human focus study was conducted to evaluate the performance of THC-infused chocolates formulated using Lexaria’s DehydraTECH™ technology. This study compared the performance of the THC-infused chocolates powered by Lexaria’s technology to concentration matched THC-infused chocolates formulated using a commercial dextrin absorption enhancer. The subjects (n=12) that participated in this study indicated a clear preference on taste and overall effectiveness with the chocolates formulated using Lexaria’s technology, and onset of effectiveness was again observed very quickly, in as little as 15-20 minutes.
Lexaria Bioscience Corp’s disruptive new patented technology DehydraTECH™ is available to be licensed.
DehydraTECH can be used to improve existing products or to create new products. It is suitable for use with a wide range of consumer product formats including:
DehydraTECH is designed to be effective in delivering most fat-soluble molecules through the human gastrointestinal system and has also demonstrated affinity for transdermal applications and even effectiveness in crossing the blood-brain-barrier once within blood plasma. Lexaria has, or is conducting, in vitro, in vivo and human clinical testing, including pharmacokinetic data gathering, for the delivery of API’s through ingestible means. Test data has consistently pointed to reduced time required to enter the bloodstream, increased absorption rate, and reported improvements in taste and smell of edible products.
Contact us today to speak about your licensing needs at ablanchard@lexariabioscience.com
Terms and rights associated with our licensing opportunities are discussed on an individual basis.
Lexaria’s typical approach to working with a new prospective licensee is to effect confidentiality terms and then collaborate with the license prospect under a non-binding letter of intent to evaluate the feasibility and applicability of the Lexaria DehydraTECH technology for the license prospect`s needs. Following this, if the license prospect is satisfied with the performance enhancements delivered by the DehydraTECH technology, Lexaria then seeks to transition to a definitive fee bearing agreement structure between it and the new licensee.
We will license our technology in any of the more than 40 countries around the world where the DehydraTECH is patented or patent-pending. Licensees can feel confident that Lexaria’s extensive IP portfolio – constantly expanding – will help to provide a competitive edge and protection against inferior methodologies or older, outdated technology.
If your company works in a different but related field, please contact us if you’d like to conduct research on applicability for your specific application.
Licensees should also always remember that DehydraTECH costs less than a penny per serving to implement – sometimes a bare fraction of a penny. Licensees may experience an increase in market share or an increase in pricing power as a result of offering their customers superior delivery characteristics. Customers are loyal to the improved performance of DehydraTECH based products.
DehydraTECH is one of the world’s ONLY delivery technologies that does not require the addition of chemicals or intimidating, complex ingredients requiring disclosure on a food label. DehydraTECH works with commons GRAS ingredients that can be organic, gluten-free, and dairy free.
If your company works in a different but related field, please contact us if you’d like to conduct research on applicability for your specific application.
Masks taste/odor
Eliminates the strong tastes/odors of lipophilic compounds, without the need for unwanted sugar or sweeteners.
Reduces time of onset
Effects are felt within 15-20 min vs. 60-120 min.
Increases bio-absorption
Increases bio-absorption by 2 – 10x, to equate or exceed that of other routes of administration like inhalational delivery.
Avoids first-pass liver metabolism
Testing has evidenced that DehydraTECH may deliver molecules through the lymphatic system instead of being subject to immediate “first pass” liver exposure, potentially mitigating unwanted side effects. More recent testing in animals even demonstrated an ability to cross the blood-brain-barrier to a degree previously thought not possible.
Interview with CEO Chris Bunka
https://youtu.be/9bRSWYKIEL8
New Enhanced DehydraTECHTM formulation delivers 8X more CBD into blood and over 19X more CBD into brain tissue than standard industry formulations.
Kelowna, British Columbia – June 4, 2019 – Lexaria Bioscience Corp. (OTCQX: LXRP) (CSE: LXX) (the “Company” or “Lexaria”), a drug delivery platform innovator, has discovered improved performance characteristics of a new version of the DehydraTECHTM delivery platform initially suitable for use in solid oral dosage forms like capsules, tablets and pills for the pharmaceutical, medical, and supplement markets. Lexaria’s innovative use of a naturally sourced formulation enhancement more than doubles DehydraTECH’s absorption performance compared to previous DehydraTECH results demonstrated to-date. The Company has filed new patent applications related to the recent innovations.
BACKGROUND
On March 20, 2019 Lexaria announced it was beginning a series of animal studies with multiple objectives, including evaluating enhanced DehydraTECH formulations that might offer improved performance. Copious data streams have been generated from these tests and continue to be analyzed.
In this arm of animal study, Lexaria tested its DehydraTECH delivery technology with compounds postulated to behave in a synergistic fashion for enhancement of gastro-intestinal absorption, which resulted in significantly enhanced DehydraTECH performance (“Enhanced DehydraTECH”).
Of note, the new Enhanced DehydraTECH and its improved performance is separate and distinct from the nanotech improvement techniques recently announced by the Company.
TEST RESULTS
In each arm of the Lexaria animal studies, 10 male Sprague-Dawley rats were administered an identically sourced CBD at a rate of 25mg per kg of bodyweight. Delivery of CBD into the bloodstream was measured at 2; 4; 6; 8; 12; 15; 30; 45; and 60 minutes after dosing. DehydraTECH-enabled CBD was measurable in animal blood within 2 to 4 minutes after dosing.
On May 15, 2019 the Company reported that DehydraTECH achieved a CBD blood concentration level that was 475% more than a generic industry medium chain triglyceride (“MCT”) coconut-oil formulation 15 minutes after dosing. Today, the Company reports that Enhanced DehydraTECH led to 811% more CBD delivery into blood than generic industry MCT coconut-oil formulations (p=0.00008); and 110% more CBD into blood than DehydraTECH in its traditional format (p=0.02).
Also of note is that both traditional DehydraTECH and Enhanced DehyraTECH delivered maximum blood concentration levels prior to the 60-minute end-of-test, with levels tapering off thereafter. The DehydraTECH technology therefore demonstrates both fast onset and fast offset as tested which is of interest for dose titration purposes when repeated dosing is desired.
CONCLUSION
DehydraTECH’s in its traditional format has been used commercially by the Company since 2014; and by the Company’s technology licensees since 2016. Lexaria has consistently introduced leading innovation for oral cannabis formats such as capsules, beverages and edibles, with a focus on the consumer experience as measured by qualities such as taste, rapidity of onset and offset, and reliability of effect. Unique among the cannabis industry, DehydraTECH has proven itself equally transformative in other sectors such as the nicotine industry where Lexaria has licensed its technology to one of the largest nicotine products companies in the world.
Enhanced DehydraTECH seems particularly adept at delivering previously unreachable quantities of CBD across the blood brain barrier and into brain tissue; more so than even the most advanced nanotech as previously reported utilized in these studies. Since most human receptor cells of the CB1 variety and otherwise that are associated with the psychotropic effects of cannabinoids are located within the brain these findings significantly expand upon the power of Lexaria’s technology to reach the target site of action for these purposes.
With this new innovation, Lexaria is establishing new performance thresholds for drug delivery technology, with tested performance of 8x (blood plasma) and more than 19x (brain tissue) of generic industry formulations. The Company intends to perform further studies to fully characterize Enhanced DehydraTECH and will work throughout 2019 to optimize implementation into the best product applications for use by its licensees.
The animal test results announced to date have led to additional new patent applications based on the positive performance results achieved. The specific nature of enhanced DehydraTECH shall remain undisclosed for proprietary reasons until the new patent filings are published. Although the current tests were limited to CBD absorption, Lexaria expects knowledge from the current innovation to apply equally to tetrahydrocannabinol (THC) as well to enhance formulation innovation for nicotine and various pharmaceutical compounds already named within the Lexaria patent suite.
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