Mountain Valley MD Confirms 800% Increase in Ivermectin Absorption with Solubilization Technology in Pre-Clinical Trial

VANCOUVER, BC, Dec. 10, 2020 /CNW/ - Mountain Valley MD Holdings Inc. (the "Company" or "MVMD") (CSE: MVMD) (FRA: 20MP) is pleased to announce that it has successfully completed its initial safety pre-clinical validation of its solubilized Ivermectin technology.  The trial was conducted to demonstrate the safety and efficacy of the Company's recent invention which enables Ivermectin (among other drugs) to become water-soluble without the use of harmful organic solvents, improving its water solubility by nearly 5,000 times*.

The pre-clinical canine trial was conducted by a third party preclinical contract research organization ("CRO") and tested the solubilized Ivermectin via both an intramuscular injection and applied to rapid dissolve oral strips with the Company's patented Quicksome™ desiccated liposome technology compared to existing oral and subcutaneous injection solutions.  The results demonstrated a significant improvement in the pharmacokinetic performance of the soluble ivermectin technology with no adverse side effects as described below.

"We now have the best pharmacokinetic data for Ivermectin in the world and the implications for both human and animal health are tremendous," stated Mike Farber, Director of Life Sciences at Mountain Valley MD.  "MVMD has succeeded in making a Nobel prize winning wonder drug even better based on overcoming its number one limitation of solubility."

Key findings:

• MVMD's solubility technology delivered 800% increase in bio availability through intramuscular (IM) injection and 500% increase in bio availability through sublingual strips compared to oral tablets.
• MVMD's IM injection reaches TMAX (the time to reach the maximum concentration of Ivermectin in the body) at 15 minutes compared to current commercial oral and subcutaneous forms which take between 6 and 36 hours and is well documented.  The Company's sublingual strips had a TMAX of 1 hour, a 600% increase over oral tablets.
• Both MVMD applications showed zero decline in CMAX (peak serum concentration that a drug achieves) over the entire 6-hour period investigated which the Company considers a very favourable indication over oral and subcutaneous forms.
• Both MVMD applications show minimal pharmacokinetic variability, with IM injection at zero percent variability and sublingual strips at 5% variability compared to 40% variability for oral tablets.  Variability contributes to the potential for adverse effects or not achieving the required therapeutic index.

MVMD's solubility technology applied to the Ivermectin drug is the only form in the world that uses strictly excipients that are currently approved by the US Food and Drug Administration (FDA), making it a leading candidate for human injection and sublingual applications as well as significantly broader husbandry and companion animal treatments based on its low viscosity.

"The Ivermectin drug is being shown to be indispensable in treating endo and ectoparasites but also emerging as a leading therapeutic for COVID-19 treatments," stated Dennis Hancock, President and CEO of Mountain Valley MD.  "The unprecedented Ivermectin intramuscular injection uptake of 15 minutes is the key to shutting down viral spreads quickly, directly contributing to the elimination of morbidity and mortality, and MVMD has created a 20-year patent around this breakthrough Ivermectin application."

The Company is proceeding immediately with an extended trial in an effort to document the relative half-life drug data over a longer period of time.

As previously reported, MVMD's patent application covers all highly solubilized macrocyclic lactones, including Ivermectin and Selamectin, which have also been shown to be effective in the treatment of tuberculosis even with limited solubility.  The Company believes its solubility technology can dramatically enhance the efficacy of both inhaled and injected Selamectin or Ivermectin providing a novel effective therapeutic for tuberculosis.

MVMD notes the testimony of Dr. Pierre Kory, a member of the Front-Line COVID-19 Critical Care Alliance, to the US Homeland Security Committee this week, during which he referenced mounting evidence of the effectiveness of Ivermectin as a therapeutic for COVID-19.  The data Dr. Kory referenced touts the ability of the drug Ivermectin to prevent COVID-19, to keep those with early symptoms from progressing to the hyper-inflammatory phase of the disease, and even to help critically ill patients recover. 

Key highlights of the presentation to the US Homeland Security Committee can be found at  https://vimeo.com/489156868 and the full video link is noted in the references.**

"Dr. Kory's testimony outlining evidence that Ivermectin can immediately prevent COVID-19 deaths may be a watershed moment not just for Mountain Valley MD, but for the entire world," stated Dennis Hancock. "Watching that commentary was such a validation of the important work our team is doing and the immediate impact our technology can have on global human and animal health."

REFERENCES/SOURCES

* The Company had previously engaged the services of a third-party preclinical contract research organization ("CRO") in connection with its Quicksome™ technology.  The CRO confirmed the solubility through a preliminary evaluation.

** "I CAN'T KEEP DOING THIS": Doctor pleads for review of data during COVID-19 Senate hearing
https://www.youtube.com/watch?app=desktop&v=Tq8SXOBy-4w

ABOUT MOUNTAIN VALLEY MD HOLDINGS INC.

Mountain Valley MD is building a world-class biotech and life sciences company organization centred around the implementation of its patented Quicksome™ oral drug formulation and delivery technologies to innovate industry leading products that are sought out globally.

MVMD's proposition for delivering Quicksome™ formulations that have rapid onset, high bioavailability, low variability and precision dosing is core to the Company's success across key health and wellness categories. Consistent with its vision towards "Helping People Live Their Best Life", MVMD applies its Quicksome™ technology to its ground-breaking work for the oral delivery of vaccines and pharmaceutical drugs as well as the development of products for pain management, weight loss, energy, focus, sleep, anxiety, and more.

The Company's patented Quicksome™ desiccation technology utilizes advanced liposomes and other stabilizing molecules to encapsulate and formulate active ingredients into highly efficient product formats that are consumed orally.  The result is a new generation of product formulations that are capable of delivering vaccines, drugs and nutraceuticals into the body faster, with greater impact, efficiency and accuracy.

For more Company information and contact details, visit www.mountainvalleymd.com.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION

Certain statements contained in this news release may constitute forward-looking information. Forward-looking information is often, but not always, identified by the use of words such as "anticipate", "plan", "estimate", "expect", "may", "will", "intend", "should", and similar expressions. Forward-looking information involves known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those anticipated in such forward-looking information.

The Company's actual results could differ materially from those anticipated in this forward-looking information as a result of regulatory decisions, competitive factors in the industries in which the Company operates, prevailing economic conditions, and other factors, many of which are beyond the control of the Company.

The Company is making forward-looking statements, including but not limited to with respect to: the ability and likelihood of success of the application of its solubility technology to Ivermectin (and other drugs), its forthcoming extended trial to document the relative half-life drug data over a longer period of time, the ability to apply Ivermectin to the treatment of COVID-19 and the implications of such application, the ability or likelihood of the technology to more quickly or easily be approved by the FDA as a result of the use of excipients already approved by the FDA, and generally with respect to its solubility technology.

The Company believes that the expectations reflected in the forward-looking information are reasonable, but no assurance can be given that these expectations will prove to be correct and such forward-looking information should not be unduly relied upon. Any forward-looking information contained in this news release represents the Company's expectations as of the date hereof and is subject to change after such date. The Company disclaims any intention or obligation to update or revise any forward-looking information whether as a result of new information, future events or otherwise, except as required by applicable securities legislation.

SOURCE Mountain Valley MD Holdings Inc.

Dennis Hancock, President and Chief Executive Officer, Mountain Valley MD Holdings Inc., Telephone: [phone], Email: [email protected], www.mountainvalleymd.com