Mountain Valley MD Holdings Inc (CSE:MVMD) (OTCQB:MVMDF) said Wednesday that it is progressing with its US Food and Drug Administration (FDA) 505(b)(2) Pathway Application for novel its Ivectosol rapid dissolve oral format.
The company said it has contracted Camargo Pharmaceutical Services LLC to provide regulatory consulting services to assist with FDA approval of Ivectosol, the company’s injectable solubilized Ivermectin technology. Mountain Valley MD called Carmago “one of the most experienced global organizations who specialize in drug and combination device product development and approval.”
It noted that Carmago has taken part in more than 1,100 agency meetings and over 200 FDA New Drug Application and ANDA (Abbreviated New Drug Applications) approvals.
READ: Mountain Valley MD Holdings poised for animal trials on its Ivectosol 1% solution
"After successful pre-clinical studies of our novel solubilized Ivectosol sublingual in our pre-clinical trials, this is a critical next step in the approval process to support our human application objectives," said Mike Farber, director of life sciences at Mountain Valley MD in a statement.
"Camargo will be a great partner to accelerate our efforts for the initial pre-IND presentation to the FDA outlining Ivermectin's prior usage history and extensive safety record for the FDA's assessment and approval pathway."
Mountain Valley MD told investors that it believes the 505(b)(2) pathway will result in a much less expensive and much faster route to approval, compared with a traditional development pathway. It could also create a new, differentiated Ivermectin product with “tremendous commercial value,” according to the company.
Upcoming trials
Mountain Valley also said it has successfully formulated Ivectosol and provided trial quantities to its Bio Safety Level 4 laboratory partner. The trials are designed to prove the superiority of solubilized Ivermectin technology versus commercially available oral form in speed and efficacy of coronavirus COVID-19 viral clearance, and will also include the more virulent B.1.351 South African COVID-19 variant. Trials are expected to start immediately as scheduled, according to the company.
"The US FDA approval would prove the efficacy and safety of MVMD's Ivectosol wafer at one of the highest standards in the world and would assist in facilitating greater access to key global markets in an accelerated capacity," CEO Dennis Hancock said in a statement.
"The human approval pathway timed with our aggressive pursuit of husbandry applications is core to making our Ivectosol products the number one commercial form of Ivermectin in the world."
The company also added that it completed dose sparing adjuvant formulation work for the inactivated polio vaccine. Tulane University School of Medicine will start trials next week.
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