Lexaria Bioscien Stock Price, News & Analysis

Lexaria Bioscience (NASDAQ:LEXX) has provided updates on its ongoing Phase 1b, 12-week chronic study GLP-1-H24-4 in Australia. The company has completed its submission to the human research ethics committee (HREC) to add Study Arm 5, which will evaluate the performance of its DehydraTECH-tirzepatide formulation. This addition follows positive findings from their previous Human Pilot Study #3.

The company has received HREC approval for all 4 original arms across all participating clinical sites, following earlier approval for the lead clinical site. Clinical test article manufacturing has been completed. The company's previous Human Pilot Study #3 demonstrated comparable results in blood glucose reduction and insulin levels, along with significantly reduced adverse events when Eli Lilly's Zepbound® was processed with Lexaria's DehydraTECH™ technology.

Lexaria Bioscience (NASDAQ:LEXX) released its annual CEO letter highlighting significant achievements in 2024, particularly in GLP-1 drug delivery technology. The company raised $13.4M net through equity raises and warrant exercises, while its stock price increased 68% during the year.

Key developments included successful completion of multiple studies demonstrating positive results with DehydraTECH technology for GLP-1 drugs: semaglutide, tirzepatide, and liraglutide. Notable outcomes included 18.8% higher semaglutide levels and 60% reduction in adverse events compared to Rybelsus®.

The company launched its first Phase 1b registrational study in Australia and received FDA clearance for a Phase 1b hypertension study. Lexaria secured 8 additional patents, expanding its portfolio to 46 patents worldwide, and entered into a Material Transfer Agreement with a pharmaceutical company for pre-clinical evaluation of DehydraTECH technology.

Lexaria Bioscience Corp. (LEXX) has received independent ethics board approval for its human pilot study GLP-1-H25-5, which will compare oral DehydraTECH-liraglutide to injectable Saxenda®. This follows successful animal studies where oral DehydraTECH-liraglutide showed a 5.88% weight reduction and 11.54% blood sugar reduction compared to baseline.

The study will involve 8-10 healthy volunteers to demonstrate safety and pharmacokinetic performance of orally dosed DehydraTECH-liraglutide. Positive results could lead to a Phase I registered trial. Liraglutide, currently sold only as injectable Saxenda® and Victoza®, generated US$849 million (Saxenda®) in H1 2024 and US$1.6 billion (Victoza®) in recent annual revenue.

Lexaria Bioscience (NASDAQ:LEXX) announced partial results from study GLP-1-H24-3, comparing oral DehydraTECH-tirzepatide to injectable Zepbound®. The oral version showed 47% fewer total adverse events and 54% fewer gastrointestinal-related events compared to the injectable version.

The oral formulation demonstrated comparable blood glucose reduction and insulin secretion levels to injected Zepbound®. Blood glucose levels decreased from 88.2±9.0 to 83.2±5.7 mg/dL for oral DehydraTECH-tirzepatide, compared to 87.8±11.3 to 81.7±4.0 mg/dL for injected Zepbound®. At peak times, the oral version induced insulin levels up to 100% higher than the injection.

Based on these promising results, Lexaria plans to add a fifth study arm to its ongoing 12-week human study in Australia (GLP-1-H24-4), testing oral DehydraTECH-tirzepatide at current and doubled doses.

Lexaria Bioscience (Nasdaq: LEXX) has initiated dosing in its Phase 1b, 12-week chronic study GLP-1-H24-4. The study aims to evaluate whether Lexaria's DehydraTECH technology enhances the safety and effectiveness of existing GLP-1 drugs. The trial includes multiple arms testing different combinations: DehydraTECH-CBD capsules, DehydraTECH-semaglutide capsules, a combination of both, Rybelsus® tablets as positive control, and potentially DehydraTECH-tirzepatide capsules. The study will be conducted across seven clinical sites in Australia and is expected to be recognized as a Phase 1b registrational study by the FDA.

Lexaria Bioscience Corp. (Nasdaq:LEXX) has announced the formation of a new Scientific Advisory Board (SAB) to guide its drug delivery platform technology development. The SAB will be chaired by John Docherty, Lexaria's President and Chief Scientific Officer, and includes three distinguished members: Dr. Michael Gibson, CEO of Baim and PERFUSE research institutes at Harvard Medical School; Dr. Karen Aust, Senior Director of Regulatory Affairs at G&L Healthcare Advisors; and Prof. Philip Ainslie, Research Chair at the University of British Columbia. The board will provide expertise in pharmaceutical development, clinical testing, and Chemistry Manufacturing and Controls (CMC) characterization, supporting Lexaria's commercialization efforts for its DehydraTECH technology.

Lexaria Bioscience (NASDAQ:LEXX) has appointed Dr. Michael Gibson as its new Chief Medical Advisor. Dr. Gibson, a highly cited interventional cardiologist and Harvard Medical School researcher, will work directly with President John Docherty to expand applications of Lexaria's DehydraTECH drug delivery platform in GLP-1 and hypertension.

As CEO of the Baim and PERFUSE research institutes at Harvard Medical School, Dr. Gibson has led over 1,250 studies and 70 FDA submissions. His institutes have published 5,500 manuscripts and operate across 7,000 sites in 57 countries. His research has been cited over 170,000 times, and he was named one of the Fifty Most Influential Voices in Healthcare by Medika Life in 2021.

Lexaria Bioscience (Nasdaq: LEXX) has engaged a CRO to conduct a human pilot study comparing oral DehydraTECH-liraglutide against injectable Saxenda®. This follows positive results from a 12-week rodent study where DehydraTECH-processed liraglutide showed a 5.88% weight reduction and 11.54% blood sugar reduction from baseline, outperforming Rybelsus® control.

The upcoming study, GLP-1-H25-5, will involve 8-10 healthy volunteers to evaluate safety and pharmacokinetic performance. If successful, it could lead to a Phase I registered trial. The market opportunity is significant, with Saxenda® generating $849 million in H1 2024 and Victoza® achieving $1.6 billion in recent annual revenue.

Lexaria Bioscience provides a strategic update on the expanding therapeutic benefits of GLP-1 drugs, highlighting their growing applications beyond diabetes and weight loss. The market, dominated by semaglutide and tirzepatide, has seen remarkable growth from $300 million in 2018 to projected $30 billion in 2024. New therapeutic applications being investigated include heart disease, Alzheimer's, liver disease, sleep apnea, knee pain, and chronic kidney disease. Clinical trials have shown promising results, including a 14% reduction in cardiovascular events and significant improvements in liver conditions, cognitive function, and kidney disease progression.