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Mountain Valley MD Successfully Completes Pre-Clinical Pharmacokinetic Study For Soluvec™1%

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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™ 1% with oral administration of commercially available branded ivermectin.

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.

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