Last week, Lexaria Bioscience Corp. (Nasdaq: LEXX) reported additional findings from its human clinical study HYPER-H21-4 which demonstrated a potentially novel mechanism of action of its patented DehydraTECH-processed cannabidiol (CBD) capsule formulation in reducing blood pressure (BP).
The Food and Drug Administration (FDA) has laid out clear guidelines for sponsors who seek to develop new anti-hypertensive drugs, specifically defining the need for medications that offer complementary modes of action.
Based on the peer-reviewed and published results (published in Biomedicine and Pharmacotherapy), Lexaria believes that DehydraTECH-CBD may qualify within these FDA guidelines. We believe our readers should be aware of the following data points:
- Lexaria previously announced that the primary efficacy and safety objectives of the study were successfully achieved, with resting BP significantly reduced in hypertensive patients, and sustained over the full 5-weeks of dosing (with zero serious adverse events being reported).
- Ongoing analyses of data from the study have revealed modulation of a circulating compound called catestatin in the patients. Catestatin is a multifunctional peptide that is known to have inhibitory effects on the sympathetic nervous system in the pathophysiology of hypertension.
- These analyses revealed that administration of DehydraTECH-CBD resulted in a statistically significant reduction in average baseline serum catestatin concentrations after 5 weeks of dosing. There were no statistically significant reductions in catestatin concentrations in the placebo group.
- As previously reported, mean arterial pressure also dropped significantly following the 5-week period of DehydraTECH-CBD dosing. Once again, there were no statistically significant reductions in the placebo group.
What Makes The Data Significant
Based on the latest study results, the data could imply that the antihypertensive effects of DehydraTECH-CBD may be explained, at least in part, by its interaction with the sympatho-chromaffin system via catestatin modulation.
The results of the study suggest a potentially unique mechanistic benefit upon cardiovascular regulation with DehydraTECH-CBD treatment that has not previously been demonstrated (to the company’s knowledge) with testing of CBD for blood pressure reduction.
The results from the study indicate that Lexaria’s DehydraTECH-CBD has the potential to offer complementary and additive BP reduction benefits on top of any degree of improvements the standard of care medications provided.
What Are The Next Steps?
If Lexaria can bring DehydraTECH-CBD as an approved hypertension treatment to the market, the technology could prove to be a significant value enhancer for the business. There is a clear medical and market need for alternative anti-hypertensive therapies like DehydraTECH-CBD and we believe the market is not assigning enough value to this part of the business.
Currently, Lexaria is conducting more study endpoint analyses and will be providing updates as they become available. We are favorable with the updates that have been provided thus far and believe the positive data trend is underappreciated by the market.
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