KELOWNA, BC - Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW), a leader in drug delivery platforms, has completed the second dosing phase of its human pilot study, GLP-1-H24-2. The study is examining the effectiveness of oral delivery of the diabetes and weight loss drug semaglutide using Lexaria's patented DehydraTECH technology.
The trial, which has now dosed all nine participants in its second arm, is a three-arm crossover investigation. It compares the semaglutide dose in three different formulations: a positive control Rybelsus® swallowed tablet, DehydraTECH-semaglutide swallowed capsules, and a novel in-mouth dissolvable DehydraTECH-semaglutide oral tablet. The final arm of the study, focusing on the dissolvable tablet, is anticipated to be completed in early July.
Lexaria's DehydraTECH technology is designed to enhance the delivery of active pharmaceutical ingredients (APIs) into the bloodstream. The second study arm used a composition processed with DehydraTECH, compliant with the U.S. Food and Drug Administration's Inactive Ingredient Database (FDA IID), delivered within swallowed capsules.
The upcoming final study arm will explore the potential for the DehydraTECH-enhanced semaglutide to be absorbed systemically through the sublingual and buccal tissues with the aim of reducing side effects and increasing drug delivery efficiency into the bloodstream.
The study's design mirrors Lexaria's initial human pilot study and aims to measure tolerability, side effects, blood levels of semaglutide, and blood glucose levels. The participants are healthy subjects who will be dosed with each test article following a 30-day washout interval between each dosing visit.
Rybelsus® (semaglutide) is currently the only GLP-1 drug approved by the FDA for oral dosing to treat diabetes and weight loss. Lexaria's technology has previously shown promise in enhancing the pharmacokinetic performance of orally delivered semaglutide.
This progress is part of Lexaria's broader efforts to develop and test DehydraTECH with various molecules for oral and topical delivery. Lexaria maintains a significant portfolio of granted patents and pending patents worldwide and operates a licensed in-house research laboratory.
The information reported is based on a press release statement from Lexaria Bioscience Corp. and does not constitute an endorsement of the claims. Investors are advised to consider the inherent risks and uncertainties that may affect the company's future performance.
In other recent news, Lexaria Bioscience Corp. has been making significant strides in drug delivery technologies and securing new patents. The company has recently acquired two patents for the treatment of hypertension and epilepsy, expanding its intellectual property portfolio to 43 granted patents globally. Furthermore, Lexaria has initiated a 12-week animal study to evaluate the effectiveness of its DehydraTECH technology in enhancing the delivery of drugs for the treatment of diabetes and weight loss.
In financial developments, Lexaria has successfully raised approximately $4.7 million from the exercise of warrants by an accredited investor. This capital is expected to extend the company's operational runway into 2025 and support the execution of their plans for 2024.
Additionally, Lexaria has received approval to commence a human pilot study focused on the delivery of GLP-1 drugs using their DehydraTECH technology. The study aims to improve the oral delivery of GLP-1 drugs, which are predominantly administered via injection.
Lastly, Lexaria has expanded its patent portfolio with the addition of three new patents in the United States and Japan, further strengthening its standing in the field of drug delivery platforms. These recent developments reflect Lexaria's ongoing commitment to innovation and growth in the pharmaceutical sector.
InvestingPro Insights
As Lexaria Bioscience Corp. (NASDAQ:LEXX) continues to advance its proprietary DehydraTECH technology for drug delivery, investors are closely monitoring the company's financial health and stock performance. According to InvestingPro data, Lexaria holds a market capitalization of 51.54 million USD. Despite not being profitable over the last twelve months, the company's gross profit margin stands impressively at 95.66%, indicating a strong ability to control the cost of goods sold relative to revenue.
InvestingPro Tips suggest that Lexaria is trading at a high Price / Book multiple of 7.9, which often indicates that the market has high expectations of future growth or sees significant intangible assets on the balance sheet. Additionally, with a robust one-year price total return of 426.32%, investors have witnessed substantial stock appreciation, reflecting optimism in the company's potential. However, the company's RSI suggests the stock is in overbought territory, which could invite caution among potential investors.
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