Lexaria Bioscience provides interim results of Phase 1b GLP-1-H24-4 study

Lexaria Bioscience (LEXX) provides the following partial 8-week interim results update on the phase 1b, 12-week chronic study GLP-1-H24-4, currently underway in Australia, focusing on the DehydraTECH glucagon-like peptide-1 study arms 2 and 5 relative to the Rybelsus control study arm 4. After 8 weeks of treatment, Lexaria’s DehydraTECH-GLP-1 arms are tracking very nicely from a safety and tolerability perspective relative to the Rybelsus control arm; most notably in terms of reductions in the incidence of gastrointestinal adverse events. Of note, every person taking Rybelsus in the Study experienced at least one AE. There was a 20.8% reduction in the overall number of persons experiencing an AE with DehydraTECH-semaglutide vs. Rybelsus and a 36.5% reduction in the total quantity of AEs derived from DHT-semaglutide vs. Rybelsus. There was also a 43.5% reduction in GI AEs from persons taking DHT-semaglutide vs. Rybelsus. In Novo Nordisk’s Semaglutide Treatment Effect in People with obesity studies, across a patient population of 3,331 people, 2,934 or 88.1% of them experienced AEs of any kind. Through 8 weeks, only 79.2% of patients in the DHT-semaglutide study arm have experienced AEs of any kind, meaning 10.1% fewer patients in the DHT-semaglutide study arm experienced AEs relatively speaking. Potentially removing all AEs from 10% of a patient population that is currently millions of people, could provide immense relief for many and encourage more people to continue on their treatment protocol without premature discontinuation as is often a challenge commercially today due to unwanted AEs. It is difficult to compare the DehydraTECH-tirzepatide AEs to any benchmark because there is no commercially available orally-dosed tirzepatide sold today, as tirzepatide is sold by Eli Lilly only in injectable formats. A meta-analysis reviewing 10 different injected tirzepatide trials involving 6,836 patients found broadly similar incidences of AEs as did the Lexaria Study examining orally dosed DHT-tirzepatide, but that meta-analysis noted that 40% to 50% of injected tirzepatide AEs were GI-related, whereas for the DHT-tirzepatide study arm that proportion of GI-related AEs through 8 weeks is much lower at 22%. This could potentially signify that oral DHT-tirzepatide might reduce AEs by as much as half, compared to the injectable tirzepatide that was evaluated in those earlier studies. Assessments of the magnitude of decreases in glycated haemoglobin, as a primary blood test for blood sugar levels, and body weight are the major efficacy endpoints of the Study. Curiously, the Rybelsus body weight performance data in the current Lexaria Study appears to be much stronger than the results shown above in both the 26-week Pioneer 1 study and in the Pioneer 6, 8-week interim data. The reasons for this apparent anomaly are presently unknown, but likely related to the small sample size of the Lexaria Study. The historical studies conducted in thousands of persons are more likely to be representative of real-world performance. For HbA1c levels it is important to understand that HbA1c measures blood glucose over a 8-12 week period of time, thus the current 8-week data from Lexaria’s Study is barely relevant compared to expected 12-week data. Furthermore, there is no statistically significant difference between the DHT-semaglutide and Rybelsus reductions in HbA1c witnessed at the 8-week point thus far in the Study. The 12-week HbA1c data should be more representative, and potentially, quite different from the 8-week data. Additional 8-week interim Study data may or may not be released as it is more fully processed and understood in the weeks to come. The vast majority of laboratory-derived data, including a battery of additional safety, tolerability and efficacy parameter assessments beyond those summarized here, and all final results will not be available until near the end of calendar-2025. The Study is currently approaching the “last patient last visit” milestone and remains on schedule.