KELOWNA, British Columbia - Lexaria Bioscience (NASDAQ:LEXX) Corp. (NASDAQ:LEXX, LEXXW), a drug delivery platform innovator, has commenced a human pilot study to assess an oral dosage form of the diabetes treatment tirzepatide, processed with its proprietary DehydraTECH technology. The study involves up to 10 healthy volunteers and began its initial dosing phase earlier this week, with completion expected by Sunday.
The study aims to evaluate the tolerability, blood absorption levels, and blood sugar control of DehydraTECH-processed tirzepatide, currently available only as an injection under the brand names Zepbound® and Mounjaro®, owned by Eli Lilly™. These brands are projected to generate around $15 billion in revenue in 2024.
Lexaria's DehydraTECH technology is designed to enhance the delivery of active pharmaceutical ingredients (APIs) into the bloodstream when taken orally. Prior human pilot studies by Lexaria showed that semaglutide, another drug in the same class, had improved absorption rates and reduced side effects when processed with DehydraTECH compared to its existing oral tablet form.
The current study, which follows a randomized crossover design, will have a multi-week washout period after the initial dosing. A second seven-day dosing phase is scheduled for mid-November, during which subjects will receive the alternate treatment condition. No serious adverse events have been reported during the initial dosing phase.
Lexaria's research efforts are part of its broader strategy to improve oral drug delivery. The company, which operates a licensed in-house research laboratory, holds 46 granted patents and several pending worldwide. Lexaria hopes to demonstrate meaningful absorption rates of tirzepatide in an oral format, which would be a new market development as tirzepatide is currently only administered by injection.
This study's progress is based on a press release statement and is part of Lexaria's ongoing research initiatives. The company's forward-looking statements reflect its aspirations and are subject to a range of risks and uncertainties. As such, there is no guarantee that the study will achieve the intended outcomes or lead to a marketable product.
In other recent news, Lexaria Bioscience Corp. reported significant growth in the glucagon-like peptide-1 (GLP-1) receptor agonist market, with revenues reaching $11.04 billion in the second quarter of 2024. The company's DehydraTECH drug delivery system has shown improved drug delivery kinetics and blood sugar control with semaglutide, a dominant player in the GLP-1 market. Lexaria Bioscience has also seen changes in leadership, appointing Richard Christopher as the new CEO and Michael Shankman as CFO, as it anticipates strong growth. The company has entered into a Material Transfer Agreement with PharmaCO for pre-clinical trials of DehydraTECH. Preliminary studies indicate a trend toward higher absorption of DehydraTECH-processed Rybelsus, suggesting potential benefits in diabetes management and weight loss efficacy. H.C. Wainwright analysts have maintained their Buy rating for Lexaria Bioscience. These are recent developments in the company's operations.
InvestingPro Insights
Lexaria Bioscience Corp.'s (NASDAQ:LEXX) innovative approach to drug delivery aligns with its strong financial position and growth potential. According to InvestingPro data, the company's revenue growth stands at an impressive 34.05% over the last twelve months as of Q3 2024, indicating a positive trajectory in line with its research and development efforts.
An InvestingPro Tip highlights that Lexaria holds more cash than debt on its balance sheet, which is crucial for a biotech company engaged in costly research and development activities like the tirzepatide study. This financial stability provides Lexaria with the runway needed to pursue its ambitious drug delivery projects.
Another relevant InvestingPro Tip notes that analysts anticipate sales growth in the current year. This expectation aligns well with Lexaria's ongoing studies and potential breakthroughs in oral drug delivery, which could lead to partnerships or licensing agreements with pharmaceutical giants.
It's worth noting that Lexaria's market capitalization is relatively small at $48.38 million, suggesting significant room for growth if its DehydraTECH technology proves successful in human trials. The company's high revenue valuation multiple, as indicated by another InvestingPro Tip, reflects investor optimism about its future potential.
For investors seeking a deeper understanding of Lexaria's prospects, InvestingPro offers 6 additional tips that could provide valuable insights into the company's financial health and market position.
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