Mountain Valley MD Receives Successful Results From BSL-4 COVID-19 Clearance Trial on Three Variants Tested With Ivectosol™

Vaughan, Ontario, CANADA

TORONTO, May 18, 2021 (GLOBE NEWSWIRE) -- Mountain Valley MD Holdings Inc. (the “Company” or “MVMD”) (CSE: MVMD) (FRA:20MP) is pleased to announce it has received its third-party Bio Safety Level 4 (“BSL-4”) lab study results from its recent COVID-19 viral clearance study conducted with its solubilized Ivermectin technology - Ivectosol™.

Study Results

  • A single dose of 2.5 milligrams per kilogram of Ivectosol™ was effective at interfering with viral replication and driving viral clearance of the B.1.1.7 COVID-19 variant.
  • Tests done in vitro showed the same antiviral effect at 5uM Ivectosol™ concentration after 24 hours and again after 48 hours against all three COVID-19 variants tested - the original B.1.1.7 variant, the South African B.1.351 variant, and the P.1 Brazil variant.

“This is the validation of our Ivectosol™ technology that we were looking for in its direct application to stop the replication of the targeted COVID-19 variants,” stated Dennis Hancock, President and CEO of Mountain Valley MD. “Knowing that Ivectosol™ has viral clearance effect on the three targeted variants we tested in the strictest lab environment in the world provides us with the confidence to pursue immediate human applications. We plan to progress quickly into phase one human trials to support our vision for broad adoption and to also provide necessary and urgent support for the most disadvantaged communities globally.”

The BSL-4 study was the first of its kind ever conducted with human grade solubilized Ivermectin anywhere in the world. This was also the world’s first to study to conduct in vitro replication on all three COVID-19 variants studied. The study was conducted in a Bio Safety Level 4 facility where laboratories are designed for diagnostic work and research on easily acquired respiratory viruses that can often cause severe or fatal disease. To assess the Company’s Ivectosol™ performance, transgenic mice were modified with human ACE2 receptors and then dosed by aerosolization with COVID-19. After five days, the subject mice were dosed with ascending therapeutic doses of Ivectosol™ as intramuscular injection.

The Company will immediately pursue a combined pharmacokinetic and phase one human trial to verify the efficacy of Ivectosol™ sublingual wafers in COVID-19 infected patients.   The new human studies are anticipated to include the “triple-mutant India variant” B.1.617, and will determine overall efficacy, speed of viral clearance and safety levels of the Ivermectin drug in the Company’s Ivectosol™ formulation.

The study design was led by the Company’s key scientific advisor, Dr. John Clements. Dr. Clements is Emeritus Professor of Microbiology and Immunology at Tulane University School of Medicine and has over 35 years of experience in vaccine, immunology and infectious diseases research and development, with a distinguished scientific career focused on developing and evaluating vaccines for a wide range of infectious diseases globally.

The Company’s previously completed pre-clinical trial work with a third-party Contract Research Organization tested 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 that the Company’s patented Quicksol™ solubilized Ivermectin offered superior pharmacokinetic performance across every single measure conducted, with no adverse side effects using up to 1/8th of the Ivermectin drug – a critical component that enables applications to use less of the Ivermectin drug while driving faster viral clearance.

“Consistent with MVMD’s previous pre-clinical trials on dose sparing, we can now pursue a meaningful reduction in the required Active Pharmaceutical Ingredient (API) Ivermectin in human applications with consistent effect,” stated Mike Farber, Director of Life Sciences. “Using less of the Ivermectin drug and enabling its delivery in novel rapid dissolve sublingual tablets and human injectable forms offers significant advantages in cost and efficacy. Even eliminating the need for water for consumption of MVMD’s sublingual Ivectosol™ we believe will be an important element in targeted third world countries where water supply can be as equally difficult to access as compared to expensive vaccines.”

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 Company is not making any express or implied claims that its technology or product has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 Coronavirus) at this time.

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 and its Quicksol™ solubilization technology for macrocyclic lactones, 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™ and Quicksol™ technologies to its ground-breaking work for advanced 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.  

The Company’s patented Quicksol™ solubilization technology covers all highly solubilized macrocyclic lactones (including the drugs Ivermectin and Selamectin). MVMD’s solubility technology applied to the Ivermectin drug is the only form in the world that only uses 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. 

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SOURCE: Mountain Valley MD Holdings Inc.

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 its forthcoming phase I human trials, over which outcomes it will have no direct control, and the implications of the acceptance of Ivectosol™ for use in the treatment of COVID-19, including variants, or otherwise.

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.


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