TrialSite first introduced Montpellier, France-based MedinCell, and their efforts to commercialize an ivermectin-based treatment for COVID-19 back in April. Now the French biotech company reports positive first results from a clinical trial aiming at the validating the safety of continuous administration of ivermectin. Presented at an international “Collaborative Workshop—Ivermectin against COVID-19,” MedinCell reports no side effects observed with the first two doses in the study, which totals three doses. Hence they announce via press release that a first long-acting injectable formulation is ready to enter regulatory development. Embracing a prophylactic strategy, the company seeks to mimic the approach taken against HIV: “preexposure prophylaxis” (PrEP) evidencing efficacy as well as the need for long-acting injectable treatments, as the are the only ones that guarantee the continuity of protection. This French company also explores a “postexposure prophylaxis” (PEP) effort for established close contact with COVID-19.
Already approved by the FDA, ivermectin is 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. The clinical trial underway, sponsored by MedinCell, aims at demonstrating its safety when taken daily in oral form in order to stimulate the continuous release of the drug by a long-acting injectable. The results could accelerate regulatory review of the long-acting injectable formulation developed by MedinCell.
The objective of the mdc-TTG program is to protect from Covid-19 with a subcutaneous injection of a several months active treatment of Ivermectin, a molecule already widely used in other indications. There is a growing body of hints and related publications showing the activity of Ivermectin on Covid-19.
The Study Ongoing
The current study is called “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.” The study involves three doses of ivermectin tested gradually at 50 μg/kg, 75 μg/kg and 100 μg/kg. Participants involve three successive cohorts of 8 healthy volunteers (one cohort per dose). Involving a daily dose of ivermectin or placebo taken orally for 4 weeks by each cohort, the study was authorized in the United Kingdom by the UK-based Medicines & Healthcare products Regulatory Agency (MHRA).
Thus far no significant side effects have been observed in the first cohorts (daily doses of 50 μg/kg, 75 μ respectively) studied successively. Continuous administration over a one-month period to healthy volunteers in the first two cohorts of the study confirms ivermectin’s safety up to a dose of 75 μg.
The preliminary pharmacokinetic data reveals a limited peak circulating plasma concentration in the first 12 hours (Cmax 35-55 ng/mL), the rapid achievement of a satisfactory regime and a regular plasma concentration of between 10 and 20 ng/mL for 28 days. Highly encouraging results thus far, they meet company’s expectations based on data in the literature. The dose-response relationship hasn’t been established as of yet.
The Goal: ‘Mass Roll-out” of Ivermectin
MedinCell’s Chief Development Officer Joël Richard, recently touted for the press release, “There is mounting evidence of Ivermectin’s prophylactic effects. That said, we are pursuing our mdc-TTG program in accordance with the highest ethical standards and on the basis of reliable scientific principles. Proving Ivermectin’s safety when administered daily over a long period of time is a crucial step in the process towards a potential mass roll-out.”
Formulation Candidate headed to Regulatory Development?
MedinCell reports in their press release that mdc-TTG uses MedinCell’s BEPO® technology. They announced that already three products based on this technology are already in clinical trials in the United States, the most advanced one at the end of Phase 3.
This program strives to offer an injectable treatment in the form of a pre-filled syringe, ready-to-use, with 24-month stability at room temperature. The MedinCell BEPO technology supports, the company claims, the formation of a small subcutaneous depot, fully bioresorbable, at the time of injection. Hence it acts as a mini pump releasing Ivermectin regularly till it disappears completely.
Along with the current clinical trial, MedinCell reports they have tested several injectable formulations in vivo over the past half year or so. They suggest they’ll have a potential candidate, active for one or two months ready for preliminary preclinical engagement of regulatory development in late December. They are also formulating a 3-month active product as well.
Regulatory Approval Timeline
IN the most favorable of scenarios, the MedinCell product could make it to submission for marketing approval by late 2021. They suggest however, that given mounting evidence for ivermectin’s safety and effectiveness for treating mild to moderate early onset COVID-19, and if the pandemic persists this could open the opportunity for mdc-TTG to qualify for a fast-track review by regulatory authorities. This MedinCell articulates, could accelerate clinical development.
MedinCell and other groups working on ivermectin and other low-cost scenarios face overwhelming competition from medical-industry-government initiatives that focus first on widespread vaccination as well as emphasis on novel, expensive monoclonal antibodies in the developed world. As the vaccines won’t solve all of the short -term potential problems with COVID-19 the challenge is that at least thus far government agencies in wealthy GPD nations show little to no interest in such repurposed, generic drug responses.
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 130 people representing over 25 different nationalities.
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