UK Clinical Trial Involving France-based MedinCell’s Ivermectin-based Product Proves Safe in Clinical Trial

UK Clinical Trial Involving France-based MedinCell’s Ivermectin-based Product Proves Safe in Clinical Trial

TrialSite’s coverage in the past year includes the ongoing research and development associated with France-based MedinCell, the biotech developing several long-acting injectable formulations of ivermectin. They are one of the few commercial entities seeking to develop a product for the market although there are others covered by this media platform. Now the Montpellier-based venture that also develops products for malaria reports that a clinical trial has validated the safety of ivermectin taken daily in oral form, to simulate the continuous release of the active substance by long-acting injection. The company seeks to advance this investigational product as one to prevent infection from SARS-CoV-2 and its mutants for several months. This study follows over 50 clinical trials from around the world, showcasing that the drug within certain dosage amounts is not only safe but also effective. This mounting data, however, is countered by a recalcitrant industry, regulatory and academic-driven resistance to a low cost, generic option targeting COVID-19.  

Study Background

In a recent press release, the company reports they have produced positive safety results. Chief Development Officer Joëll Richard commented that “All our programs are developed in accordance with the highest ethical standards and on the basis of reliable scientific principles with a view to potential massive deployment. Proving the safety of ivermectin in regular daily administration over a long period was an essential step for our ivermectin programs, in particular mdc-TTG in Covid-19.”

The company shared a commonly understood fact that ivermectin has already been administered as a once-daily treatment to hundreds of millions of patients worldwide. Its safety as a once-daily treatment has been demonstrated and documented.

Study Introduction

MedinCell tested ivermectin taken daily in oral form to simulate the continuous release of the active substance by a long-acting injectable. After completion, the study confirms the safety of ivermectin up to a dose of 100 µg / kg / day in continuous administration over 1 month in healthy volunteers. No significant difference was observed between the treated volunteers and the placebo volunteers in the three cohorts studied successively (daily doses of 50 µg / kg, 75 µg / kg and 100 µg / kg respectively). 

The pharmacokinetic data of the three cohorts shows a limited peak circulating plasma concentration in the first 12 hours (Cmax between 25-60 ng / mL) and the rapid achievement of a stationary regime and a regular plasma concentration of between approximately 10 and 30 ng / mL for 28 days, depending on the dose administered. These preliminary results are considered positive and live up to Company expectations based on the data in the literature. The dose-response relationship has not yet been established. 

After study completion and in regard of the expert review conducted by Professor Jacques Descotes1 (March 2021), the safety profile of ivermectin supports the progress of MedinCell programs using this molecule, in particular mdc-TTG against Covid-19 and mdc-STM against malaria. 

Covid-19: The prophylactic strategy 

“Our hypotheses are being confirmed, says Christophe Douat, CEO of MedinCell: the pandemic continues, and vaccination may not be enough to stop it. The body of clinical data and scientific knowledge supporting the efficacy of ivermectin at a therapeutic dose against Covid-19, in particular as a prophylaxis, continues to grow. In this context, our treatment, based on a widely known molecule, which could be stored at room temperature and which aims to offer protection for several months after a simple injection against Covid-19 and its variants, could become a key tool of the anti-Covid arsenal. Our goal is still to have a product ready in 2022.” 

Currently in regulatory development, the mdc-TTG program aims to offer an injectable treatment in the form of a pre-filled syringe, ready to use, and stable for 24 months at room temperature. MedinCell’s BEPO® technology will allow the formation of a small subcutaneous deposit at the time of injection. It will act as a mini pump that releases ivermectin regularly until it disappears completely. The long-acting formulation of ivermectin in the mdc-TTG program could provide protection against Covid-19 and its mutants for several months after a single injection. It could also be administered to people identified as Covid-19 contact cases to protect them. 

About the Clinical Safety Study 

  • Study title Exploratory phase 1, randomized, double-blind trial assessing the pharmacokinetic profile, safety and tolerability of a regime of continuous daily administration of Ivermectin to healthy volunteers. 
  • Participants involve 3 successive cohorts of 8 healthy volunteers (one cohort per dose) 
  • Administration Daily dose of Ivermectin or placebo taken orally for 4 weeks by each cohort 

Doses tested

  • Cohort 1: 200 µg/kg (day 1) + 50 µg/kg daily (day 2 to 28)
  • Cohort 2: 200 µg/kg (day 1) + 75 µg/kg daily (Day 2 to 28) 
  • Cohort 3: 200 µg/kg (day 1) + 100 µg/kg daily (day 2 to 28) 
  • Authorization of clinical trials MHRA (Medicines & Healthcare products Regulatory Agency – United Kingdom) 
  • Study period September 2020 – March 2021 

About MedinCell

MedinCell is a clinical stage pharmaceutical company that develops a portfolio of long-acting injectable products in various therapeutic areas by combining its proprietary BEPO® technology with active ingredients already known and marketed. Through the controlled and extended release of the active pharmaceutical ingredient, MedinCell makes medical treatments more efficient, particularly thanks to improved compliance, i.e. compliance with medical prescriptions, and to a significant reduction in the quantity of medication required as part of a one-off or chronic treatment. The BEPO® technology makes it possible to control and guarantee the regular delivery of a drug at the optimal therapeutic dose for several days, weeks or months starting from the subcutaneous or local injection of a simple deposit of a few millimeters, fully bioresorbable. Based in Montpellier, MedinCell currently employs more than 140 people representing over 25 different nationalities.

Call to Action: TrialSite will continue to monitor this and other unfolding events, involving ivermectin.

Responses

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  1. That MedinCell undertook a research program aimed at making Ivermectin a marketable , long term, injectable prophylactic against Covid-19 very clearly demonstrates that their leadership have long been in possession of clear evidence of the efficaciousness of Ivermectin. MedinCell leadership also demonstrates a knowledge of the redundant testing required by the medical establishment to prove Ivermectin is not harmful but at the same time finding the rate at whick constant replenishing the serum content of Ivermectin is not harmful. Good for them. I hope that company reaps financial reward for their insight, planning, and persistence.

    However, a side benefit to those of us who have followed trialsitenews’ reporting is information to help devise our own use of Ivermectin derived from sources such as formulations sold as animal medications. Whether or not it is advisable to self medicate, is an issue best taken on by people with as much knowledge as can be gleaned in this environment of official censorship of news by both political and economic interests. I have more than a dozen friends and acquaintances who having developed Covid-19, taken a short course of Ivermectin as treatment and recovered within 24 to 48 hours. Most of those are over the age of 70–some by several decades. Most of those took the animal medication , but recently Docs in my part of Texas have begun to use Ivermectin as treatment of Covid-19 patients with equal success.

    As word spreads about Ivermectin’s effectiveness, the sale of Agrimectin Noromectin, Ivomec, etc. has increased as indicated by the frequency with which agricultural supply stores run out of a product that animal husbandmen have long depended on and that such stores supplied and always before this pandemic, kept in stock.

    I have taken periodic doses of 200 mcg/kg body weight since late April or May of 2020 based on reports of its use in third world nations. Starting with a monthly dose, I have narrowed it down to biweekly. It is good to know that greater frequency than that is not harmful, but I do not plan to increase the dosage for now. A curative dose at the first signs of disease will, I believe, stop it before it does its great harm to our bodies. Those of my acquaintance who take prophylactic doses have not experienced a cold while doing so. Several other maladies have disappeared also, which to me indicates that research on its effect on Shingles, seborrhea, arthritis and a host of other maladies ought to be undertaken.
    All that is with oral doses of a solution of 1% Ivermectin, 40% glycerol, and the balance Propylene gycol.
    Sorry, MedinCell, but I will stick to oral doses and leave the injections to those who find them preferable to swallowing. Perhaps MecinCell should undertake the task of having legislation approved that would put Ivermectin on the shelves of stores beside asprin, tylenol, cough syrup, and the host of over-the-counter meds available now. They might be prepared to offer Ivermectin in over-the-counter formulations and still turn a profit. The basic fact to hold in the forefront of our minds is that Ivermectin, like hydroxychloroquine is best taken taken as treatment at the first sign of infection. Perhaps better than that would be to take a periodic oral dose to ward off the illness. MedinCell has shown us how to safely use Ivermectin regularly and long term.