Mountain Valley MD Holdings (MVMD) (OTCQX: MVMDF) has announced the successful completion of its pre-clinical pharmacokinetic study. The pre-clinical pharmacokinetic study – IM032, was done on male beagle dogs by comparing the intramuscular (IM) and subcutaneous (SC) dosing of SoluvecTM 1% with oral administration of commercially available ivermectin. A third-party contract research organization conducted the pre-clinical study.
The results of the pre-clinical canine trial tests demonstrated that:
- Soluvec, if administered IM and SC at the same dose level (300 mg/kg) as the reference product oral ivermectin, will result in mean maximum plasma concentrations of 2.6 and 1.6 fold higher Cmax, respectively.
- The mean systemic exposure of Soluvec was 6.8 and 7.0 fold higher on average for IM and SC administration compared to oral ivermectin as measured by AUCLast.
- Both IM and SC formulations of Soluvec absorbed rapidly after dosing and sustained longer above the limit of the study’s quantification when compared to oral ivermectin.
Dr. Azhar Rana, the Chief Medical Officer of MVMD, said, “The data generated for IM nad 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.”
Mountain Valley MD is currently working on a full manuscript for publication and making efforts to complete the regulatory package needed to request a pre-IND meeting to discuss with the FDA the effects of Soluvec for current indications of ivermectin under the 505(b)(2) pathway. The 505(b)(2) pathway is a new drug application pathway that will help prevent unnecessary duplication of studies on previously approved drugs.
MVMD’s solubility technology which produced Soluvec as applied to the Ivermectin drug, is the only form in the world that strictly uses excipients approved by the US FDA. This has made the drug a potential candidate for human injection.
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