Mountain Valley MD Successfully Completes Pre-Clinical Pharmacokinetic Study For Soluvec™1%
Mountain Valley MD Holdings Inc. (MVMDF) has successfully completed a pre-clinical pharmacokinetic study (IM032) of its new drug Soluvec™ in male beagle dogs. The study compared intramuscular and subcutaneous dosing of Soluvec™ with oral ivermectin. Results showed that Soluvec™ produced significantly higher plasma concentrations and systemic exposure than ivermectin. The company plans to submit a regulatory package for a pre-IND meeting with the FDA under the 505(b)(2) pathway for expedited drug approval.
- Soluvec™ demonstrated 2.6 and 1.6 fold higher Cmax compared to oral ivermectin when administered IM and SC, respectively.
- Mean systemic exposure of Soluvec™ was 6.8 and 7.0 times higher for IM and SC administration than oral ivermectin.
- Study results support potential dose reductions for effective treatment, enhancing safety and efficacy outcomes.
- None.
TORONTO, June 27, 2022 (GLOBE NEWSWIRE) -- Mountain Valley MD Holdings Inc. (the “Company” or “MVMD”) (CSE: MVMD) (OTCQX: MVMDF) (FRA: 20MP) is pleased to announce the successful completion of its pre-clinical pharmacokinetic study - IM032 - in male beagle dogs comparing intramuscular (“IM”) and subcutaneous (“SC”) dosing of Soluvec™
The pre-clinical canine trial was conducted by a third-party preclinical contract research organization (“CRO”) and the test results demonstrated:
- Soluvec, administered IM and SC at the same dose level (300 mg/kg) as the reference product oral ivermectin, resulted in mean maximum plasma concentrations represented by a 2.6 and 1.6 fold higher Cmax, respectively.
- The mean systemic exposure of Soluvec™ was on average 6.8 and 7.0 fold higher respectively for IM and SC administration as compared to oral ivermectin as measured by AUCLast (area under the curve from the time of dosing to the last measurable concentration).
- Both SC and IM formulations of Soluvec™ absorbed quickly after dosing and sustained longer above the lower limit of quantification in the study, compared to oral ivermectin.
“The data generated for IM and SC administration is very encouraging in our goal to achieve effective plasma concentrations with Soluvec™ compared to oral ivermectin, while also raising some interesting questions about the potential for dose reductions to achieve efficacy and safety outcomes in future applications,” commented Dr. Azhar Rana, Chief Medical Officer of MVMD.
The Company is currently developing a full manuscript for publication and working to complete the regulatory package required to request a pre-IND meeting with the FDA in order to discuss the use of Soluvec™ for current indications of ivermectin (i.e. for the treatment of parasitic infections) under the 505(b)(2) pathway. The 505(b)(2) new drug application is one of three FDA drug approval pathways and represents an appealing regulatory strategy by way of helping to avoid unnecessary duplication of studies already performed on a previously approved drug. The Company believes the 505(b)(2) pathway will result in a less expensive and faster route to approval for Soluvec™ for the current indications of ivermectin compared with a traditional development pathway, while creating a solubilized ivermectin product that uses no harmful organic solvents.
“This data documents the successful application of MVMD’s Quicksol™ solubilization technology to the drug ivermectin, and validates the ability of the technology to provide new potential administration routes that could be studied in humans for the treatment of parasitic infections,” stated Dennis Hancock, President & CEO of MVMD. “The completion of this study reaffirms the previously stated key benefits the Company believes important for Soluvec™, effectively affirming improved pharmacokinetic parameters compared to standard ivermectin.”
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 potential candidate for human injection.
ABOUT MOUNTAIN VALLEY MD HOLDINGS INC.
Mountain Valley MD is building a world-class organization centered around the implementation and licensing of its key technologies to global pharmaceutical, vaccine and nutraceutical third parties:
- patented Quicksome™ oral drug formulation and delivery technologies,
- patented Quicksol™ solubility formulation technology
Consistent with its vision towards “More Life”, MVMD applies its Quicksome™ and Quicksol™ technologies to its 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.
MVMD’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 could be capable of delivering vaccines, drugs and nutraceuticals into the body faster, with greater impact, efficiency and accuracy.
MVMD’s patented Quicksol™ technology covers all highly solubilized macrocyclic lactones that could be effectively applied in multiple viral applications that could positively impact human and animal health globally.
For more Company information and contact details, visit www.mvmd.com.
SOURCE: Mountain Valley MD Holdings Inc.
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 Company’s goal being the achievement of effective plasma concentrations with Soluvec™ compared to oral ivermectin; the Company’s ability to complete a manuscript and a regulatory package, and to submit to the FDA in order to request a pre-IND meeting; the impact of utilizing the 505(b)(2) pathway, including a less expensive and faster route to approval.
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.
Neither the CSE nor OTCQX has reviewed or approved the contents of this press release.
FAQ
What were the results of the Soluvec™ pharmacokinetic study conducted by Mountain Valley MD Holdings Inc. (MVMDF)?
How does Soluvec™ compare to oral ivermectin in terms of systemic exposure?
What is the significance of the FDA 505(b)(2) pathway for MVMDF's Soluvec™?
Who conducted the pre-clinical study for Soluvec™?
What future steps does Mountain Valley MD Holdings Inc. plan after the study?
