LEXX’ Sweet Opportunity in GLP-1s

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By John Vandermosten, CFA

NASDAQ:LEXX

READ THE FULL LEXX RESEARCH REPORT

Following the rollover into the new year, Lexaria Bioscience Corporation (NASDAQ:LEXX) updated stakeholders with the final results from its human pilot study investigating the DehydraTECH (DHT) delivered GLP-1 agonist Rybelsus. As a reminder, Lexaria had previously provided preliminary data late last year for this study regarding the evaluation of the glucagon-like peptide-1 (GLP-1) agonist class formulated with DHT. The goal of the research is to determine whether or not employing DHT for delivery could reduce side effects, enhance weight loss, improve health outcomes, increase bioavailability and reduce cost relative to other methods of semaglutide delivery. Shortly after sharing the final results, the company set out a comprehensive plan to further develop DHT with GLP-1 agonists. Five additional studies are planned to support commercial partnering and commercial applicability of synthesizing GLP-1 agonists with DHT.

Human Pilot Study Final Data

Lexaria had provided preliminary data in late November with respect to the pilot study which compared 7 mg of DHT-Rybelsus versus a matching amount of drug substance in a Rybelsus tablet. Rybelsus has distinguished itself with strikingly low bioavailability of 1% or less, providing an opening for an alternative that achieves better results. The exhibit below is updated from the previously released data and illustrates final blood plasma levels of DHT-Rybelsus and Rybelsus tablets over a 10-hour period with the DHT formulation achieving higher blood levels at each measurement point. We note that compared to the initial report of the data back in November, the separation of the two curves is greater in the final report with the Rybelsus control generating slightly lower blood levels in comparison.

The separation between the DHT and Rybelsus curves was maintained for the entire 24-hour measurement period and was about 25% higher at the final hour. For the 24-hour observation period, blood levels for the DHT-Rybelsus arm averaged 15% higher than the control.

Two of the three control subjects and none of the four DehydraTECH GLP-1 subjects reported experiencing moderate nausea. All three control subjects reported experiencing mild nausea at both the 2-hour and 10-hour timepoints whereas only one DehydraTECH semaglutide subject reported mild nausea and only at the single, 2-hour timepoint.

Updated data for blood glucose levels was also provided in the final results for the pilot study. Compared with the first report, both curves were generally lower than before. The final results demonstrated lower overall blood glucose levels and less variability for the DHT-Rybelsus formulation compared with Rybelsus tablets. The study evaluated blood glucose levels every 20 minutes for the first few hours then every hour over the measurement period. Subjects consumed a standardized meal at the 240-minute (4 hour) mark and a snack at the 360-minute (6 hour) mark. As can be observed in the following exhibit, the spike in blood glucose levels for the DHT-Rybelsus subjects was less pronounced than that for the Rybelsus tablet group following the meal at the 240 minute mark.

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