Mountain Valley MD looking to eradicate needles with its patented Quicksome oral drug delivery technology

Quicksome utilizes advanced liposomes and other stabilizing molecules to encapsulate and formulate active ingredients into highly efficient product formats Developing products for pain management, weight loss, energy, focus, sleep and anxiety Also looking at the fight against the coronavirus (COVID-19) What Mountain Valley MD does: Mountain Valley MD Holdings Inc (CSE:MVMD) (OTCMKTS:MVMD) is building a world-class biotech and life sciences company centered around the implementation of its patented Quicksome oral drug formulation and delivery technologies. The Vancouver, British Columbia-based company applies its Quicksome desiccation technology towards the oral delivery of vaccines and pharmaceutical drugs as well as the development of products for pain management, weight loss, energy, focus, sleep and anxiety. It is also looking at the fight against the coronavirus (COVID-19). The patented Quicksome technology utilizes advanced liposomes and other stabilizing molecules to encapsulate and formulate active ingredients into highly efficient product formats that are consumed orally. Quicksome enables unprecedented delivery impact through sublingual and buccal formats that provide direct absorption into the bloodstream, dramatically improving drug efficacy, dosing and end-user experience. 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. Activating molecules and formulas with Quicksome also vastly improves their economic viability, opening up markets and applications that were previously not feasible for our partners. By way of example, the group is working on applications where it can eliminate the need for subcutaneous injection with needles. Such applications can vastly improve access and the economics for life-saving drugs globally. The Quicksome technology has been in development since 2010, and initially incorporated into several commercial dietary supplement products. To date, the company has 14 patents in its portfolio, 12 extensions and has filed over a dozen provisional patents with respect to its Quicksome technology. Led by president and CEO, Dennis Hancock, the group’s management team brings together world-class leadership across mucosal delivery sciences, molecular research, IP and legal management, marketing, distribution and financial services How is it doing: Mountain Valley MD has had a busy start to 2021 on several fronts, including in the battle against coronavirus (COVID-19). On March 16, the company revealed it was starting husbandry animal trials in Bangladesh for the company’s injectable solubilized Ivermectin technology, Ivectosol 1%. Mountain Valley MD will be working under the supervision of Bangladesh’s Ministry of Fisheries & Livestock on the trials. Ivectosol 1%, a fully solubilized form of the anti-parasitic drug Ivermectin, will be tested in cattle, goat and poultry under the supervision of the Bangladesh government's approved and authorized laboratories and research institutes, Mountain Valley told investors. The tests will be conducted by way of intra-muscular needleless injection of Ivectosol 1% in bid to demonstrate superior pharmacokinetics in terms of CMAX (peak serum concentration that a drug achieves) and AUC (area under the curve) with advanced drug withdrawal time control, versus current commercially available forms. The company is working with local partner R&G Group of Bangladesh to quickly advance research, development and manufacturing capabilities inside the country, it told investors. Trials are set to begin in early April and will last around 30 days, the company said. At the start of the month, Mountain Valley MD announced that it was progressing with its US Food and Drug Administration (FDA) 505(b)(2) Pathway Application for novel its Ivectosol rapid dissolve oral format. The company said it has contracted Camargo Pharmaceutical Services LLC to provide regulatory consulting services to assist with FDA approval of Ivectosol, the company’s injectable solubilized Ivermectin technology. Mountain Valley MD called Carmago “one of the most experienced global organizations who specialize in drug and combination device product development and approval.” It noted that Carmago has taken part in more than 1,100 agency meetings and over 200 FDA New Drug Application and ANDA (Abbreviated New Drug Applications) approvals. Also in March, Mountain Valley MD announced that it has achieved a water solubilized selamectin product using its patent-pending Quicksol technology. To date, the company noted, selamectin was considered a virtually water-insoluble molecule with tremendous potential in treating parasitic infestations in husbandry and companion animals, as well as mycobacterium-based infections, including buruli ulcer, leprosy, and tuberculosis.  Mountain Valley MD said its scientists have successfully solubilized selamectin at 15mg/ml into a water solution without any organic solvents, which it believes is a critical achievement to allow formulation into topical application creams, oral rapid dissolve sublingual tablets, and injectable applications.  The company has filed for trademark protection under the brand name Selactosol to support its continuing work within the Quicksol line of water solubilized macro-cyclic lactones. The company has focused its initial efforts on already-approved macro-cyclic lactones because they will yield the broadest commercialization opportunities in the shortest period of time. Having successfully applied the Quicksol solubilization technique to the selamectin drug, Mountain Valley MD said it will now proceed to formulate Selactosol 1.5% for preclinical evaluation trials of mycobacterium-based infections such as buruli ulcer, leprosy, and tuberculosis. On February 22, Mountain Valley MD said it would start testing the South African coronavirus variant in an upcoming study analyzing viral clearance efficacy with its solubilized Ivermectin technology. The company believes its solubilized Ivermectin could work for a broad therapeutic across a wide range of viruses in the future, not just limited to COVID-19. And at the end of January, the company said it had executed an agreement to conduct its Bio Safety Level 4 (BSL-40) lab study of coronavirus (COVID-19) viral clearance in transgenic mice. Mountain Valley MD said the study is designed to prove the superiority of its solubilized Ivermectin technology versus a commercially available oral form in speed and efficacy of viral clearance.  Mountain Valley MD noted that there are less than 30 BSL-4 facilities in the world capable of performing the study, which is expected to begin in late February 2021. It said the study results are expected in April 2021. The company also said the study, which will be led its key scientific advisor Dr John Clements, will be the first of its kind ever conducted with human-grade solubilized Ivermectin anywhere in the world. On February, 25, the company said it had struck an agreement with Circadian Wellness Corp to apply Quicksome technology to mushroom neutraceutical products. The agreement includes ongoing product royalties and an initial payment of C$250,000 to Mountain Valley MD – the company’s first revenue. The $250,000 - which is comprised of $200,000 cash and $50,000 in Circadian shares - will go towards formulation, product development and sample development work, the company said. Mountain Valley MD said it was working closely with Circadian on proprietary formulations for mushroom-infused products that achieved a significant increase in overall molecule efficacy with Quicksome desiccated liposome technology applied across a variety of rapid dissolve oral products. Circadian is finalizing its product plans and go-to-market strategy for a broad line of naturally derived mushroom products that will first be distributed in North America, it added. At the start of February, Mountain Vally MD announced that it had hired the Tulane University School of Medicine in New Orleans to be its Contract Research Organization (CRO) to carry out its adjuvant inactivated polio vaccine (IPV) study beginning that month. The company has developed porous aluminum nanostructures to use as adjuvants in vaccines against various infectious diseases, including polio. On the patent front, in January, Mountain Valley MD said it had filed a patent to protect its Porous Aluminum Nano-Structured Adjuvant (PANA) process for vaccine dose sparing, which allows a vaccine to be delivered at a fraction of its normal dose without losing potency.  The PANA patent includes a novel adjuvant that was created to be fully compatible with current vaccine manufacturing methods. Adjuvants are pharmacological or immunological agents that improve the immune response of a vaccine, the company said, enabling vaccines to produce more antibodies and achieve longer-lasting immunity, thus allowing for lower dosage. And in the same month, the company said it has received approval from the Canadian Intellectual Property Office for the patent filing around its Quicksome technology. The company released pre-clinical trial data on December 10, 2020, where a solubilized version of the drug Ivermectin was administered via its Quicksome desiccated liposome technology as compared to an existing oral Ivermectin solution. The results demonstrated that the Quicksome technology was able to successfully administer Ivermectin across the mucosa, with a significant improvement in the pharmacokinetic performance compared to current oral formats. On the housekeeping front, on April 20, Mountain Valley MD said it was proceeding with its application to list its shares on the Toronto Venture Exchange (TSX-V) and planned to submit an application imminently. The company noted that listing on the TSXV is subject to the satisfaction of listing requirements and the approval of the exchange. In the meantime, Mountain Valley MD's shares will continue to trade on the Canadian Securities Exchange under the ticker symbol MVMD.  On January 11, Mountain Valley MD announced that it had submitted an application to have its common shares listed for trading on the OTCQB market in New York. In that same statement, the company has also said it had begun to receive exercises of warrants from its shareholders, issuing 3,982,570 common shares for gross proceeds of $1,393,899. It noted that the significant majority of the company's warrants were scheduled to expire during the 2021 calendar year, with the majority of those expiring on February 21, 2021. Inflection points: News on South African coronavirus variant testing News on Husbandry animal Ivectosol 1% trials TSX-V listing completion What the boss says: In March's statement regarding the achievement of a water solubilized selamectin product using its patent-pending Quicksol technology, Mountain Valley MD CEO Dennis Hancock: "We continue to accelerate our focus and efforts on solving the most significant human and husbandry animal health problems facing our global population." "We are very optimistic that this breakthrough on selamectin will help MVMD pursue near-term licensing and commercialization opportunities consistent with our business plan," he added. Contact the author at jon.hopkins@proactiveinvestors.com