Berberine is a natural plant extract that has been used in eastern medicine for thousands of years, and more recently also in the western world. There is an abundance of research on berberine, and its effectiveness in reducing cholesterol and triglycerides is well-established. The main challenges with the use of berberine in its traditional oral format are exceptionally low bioavailability (< 2%) and highly adverse gastrointestinal events. Transdermal berberine from Delivra overcomes these challenges, showing 8-times higher concentration levels in the blood than oral, with no gastrointestinal side effects, and proved significantly more effective than oral in reducing cholesterol and triglycerides in a model of metabolic disease. This achievement represents a first-in-class platform that may prove effective in reducing cholesterol, triglycerides, and other hallmarks of cardiovascular disease.
Delivra’s research and development includes formulations, compounding, stability testing, and measurement of systemic penetration and delivery of topical berberine and the closely related natural product, dihydroberberine (DHB). Delivra-berberine and Delivra-DHB achieve circulating blood levels 8-times higher than an oral equivalent treatment, which overcomes a key limitation of this natural compound. With increased berberine blood levels is an expected increase in this compound’s effectiveness to reduce cholesterol and triglyceride levels, with Delivra-DHB achieving a profound reduction in cholesterol by 34% and reduction in triglycerides by 85%, as compared to control. While this is pre-clinical data, it is very promising in the context of published rates for leading statin drugs in the range of 20-35% reduction in cholesterol and 10-30% reduction in triglycerides.
In certain cases, this treatment may provide a natural alternative to the use of statin drugs, the most prescribed drug class in the world, and most commonly recognized by the trade names LipitorTM (Pfizer Inc.), ZocorTM (Merck & Co. Inc.), and CrestorTM (Astra Zeneca Limited). A Delivra berberine therapy could avoid the side effects associated with statin drugs, including muscle pain, liver damage, stomach upset, increased blood sugar, and a range of neurological issues. Interestingly, preliminary data suggests the Delivra transdermal berberine may also function synergistically to enhance the performance of statin drugs, potentially allowing greater benefits while taking less drug.
“These strong results demonstrate the potential for a break-through natural product to address a globally prevalent health issue,” said Dr. Joe Gabriele, founder and CEO of Delivra. “To bring to market a natural product that works as well or better than some of the world’s most commonly prescribed drugs, without the side effects, would be a game changer for the treatment of cardiovascular disease. We will continue to advance our research, through further pre-clinical work and then into clinical trials, and we look forward to continuing to report to shareholders on our progress.”
Delivra has filed a provisional US patent to protect its unique berberine formulations.
ABOUT DELIVRA CORP.
Delivra Corp. is a developer of transdermal technologies for the delivery of pharmaceutical and natural molecules through the skin, rather than via pills. Delivra manufactures and sells a growing line of natural topical creams under the LivReliefTM brand, for conditions such as joint and muscle pain, nerve pain, varicose veins, wound healing, and sports performance. LivReliefTM products are available in pharmacies, grocery chains, and independent health food stores across Canada, and on-line at livrelief.com. LivReliefTM products are also available on-line and on Amazon in the United States. In parallel with its consumer products business, Delivra also has a mandate to license its unique, proven, and patent-pending delivery platform to global pharmaceutical companies for the transdermal delivery of third party active ingredients to treat a broad range of conditions. With a global transdermal drug delivery market forecast to grow to USD $40 billion by 2018 (Source: Kelly Scientific), Delivra believes the licensing opportunity is robust. Delivra is headquartered in Burlington, Ontario and has a research and development laboratory in Charlottetown, PEI.
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Certain information in this press release may constitute forward-looking information. This information is based on current expectations that are subject to significant risks and uncertainties that are difficult to predict. Actual results might differ materially from results suggested in any forward-looking statements. The Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward looking-statements unless and until required by securities laws applicable to the Company. Additional information identifying risks and uncertainties is contained in the Company’s filings with the Canadian securities regulators, which filings are available at www.sedar.com.
For more information, please contact:
Chris Schnarr, President and CFO