Good morning. I am very pleased to share some very encouraging results related to our solubilization technology as applied to the drug ivermectin (Soluvec™ 1%). This morning we have distributed a media release announcing the successful completion of our pre-clinical pharmacokinetic study in male beagle dogs where we compared intramuscular (“IM”) and subcutaneous (“SC”) dosing of MVMD’s Soluvec™ 1% against 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:
MVMD’s Chief Medical Officer, Dr. Azhar Rana, stated that the data generated for intramuscular and subcutaneous 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.
This statement to me summarizes much of our work at MVMD as we look to “do more with less” as a tenant of our technology applications. Working to deliver molecules into the body more effectively, with greater precision over current oral indications.
We are 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. We believe 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. The completion of this study reaffirms the previously stated key benefits that MVMD believes important for Soluvec™, effectively affirming improved pharmacokinetic parameters compared to standard ivermectin.
Today’s news is a great reinforcement of the efficacy of our solubilization technology and our ability to progress our work in a meaningful way towards solving significant health and wellness problems.
Thank you to all of you for your ongoing support of our transformational work!
President & CEO, Mountain Valley MD