Mountain Valley MD Holdings Inc (CSE:MVMD, OTCQB:MVMDF) said it has completed its pre-clinical pharmacokinetic study of its parasitic infection treatment Soluvec, finding that it outperformed commercially available ivermectin by certain metrics.
The study tested intramuscular (IM) and subcutaneous (SC) dosing of Soluvec 1% against oral administration of ivermectin in male beagle dogs. The pre-clinical canine trial was conducted by a third-party pre-clinical contract research organization.
Soluvec administered IM and SC at the same dose level (300 milligrams of medication per kilogram of body weight) as the reference product oral ivermectin resulted in mean maximum plasma concentrations represented by a 2.6 and 1.6-fold higher maximum concentration, respectively.
READ: Mountain Valley MD updates on its technologies and pre-clinical progress across broad husbandry animal and human applications
Both SC and IM formulations of Soluvec were 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,” said the company's chief medical officer Azhar Rana.
Mountain Valley MD is currently developing a full manuscript for publication and working to complete the regulatory package required to request a pre-IND (Investigational New Drug) meeting with the US Food and Drug Administration to discuss the use of Soluvec for current indications of ivermectin under the 505(b)(2) pathway.
The 505(b)(2) new drug application is one of three FDA drug approval pathways, which the company said represents an appealing regulatory strategy by way of helping to avoid unnecessary duplication of studies already performed on a previously approved drug.
For this reason, it is expected to be a less expensive and faster route to approval compared to a traditional development pathway, while still creating a solubilized ivermectin product that uses no harmful organic solvents, the company said.
“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,” CEO of Mountain Valley Dennis Hancock said. “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.”
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