Clinical trial validates the safety of ivermectin taken daily in oral form, to simulate the continuous release of the active substance by a long-acting injection.
No side effects were observed with the three doses of ivermectin tested up to 100 µg / kg.
MedinCell develops several long-acting injectable formulations of ivermectin, the most advanced aims at preventing infection from Covid-19 and its mutants for several months.
Positive results of the safety study
“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,” said Joël Richard, Chief Development Officer at MedinCell.
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. 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.