The randomised, double-blind, exploratory phase I trial A has been designed to evaluate the pharmacokinetic profile, safety and tolerability of a continuous daily dosing regimen of Ivermectin in healthy volunteers.
MedinCell’s mdc-TTG programme uses BEPO technology, which enables to form a small subcutaneous depot and fully bio-resorbable at the time of injection.
The current clinical study will enable to validate Ivermectin safety when taken regularly in oral form over four weeks to simulate the continuous release of the active ingredient by a long-acting injectable.
MedinCell’s study will gradually assess three increasing doses by daily administration over four weeks in three successive cohorts of healthy volunteers.
The study will help in the regulatory development of the long-acting injectable formulation and its potential mass deployment.
The first injectable formulations are currently being tested in vivo along with the first clinical trial. Based on the positive results, the company intends to apply for market authorisation by the end of 2021.
MedinCell, along with Corbion, established a joint venture to support large-scale production capacities and supply biocompatible polymers needed for the production of tens of millions of doses.
MedinCell has designed the programme to deliver an injectable treatment in the form of a pre-filled syringe and ready-to-use with 24-month stability at room temperature.
MedinCell CEO Christophe Douat said: “We keep focused on developing the third path against Covid-19, prevention, with our BEPO technology which has already attracted prestigious partners thanks to its large-scale deployment potential.
“Our program against Covid-19 is a bit like David versus Goliath. But we have already demonstrated the strength of our alliance model, which allows us to collaborate with the best partners.”
Recently, Chinese biopharmaceutical company Sinovac Biotech has begun phase III clinical trials for its inactivated Covid-19 vaccine candidate in Turkey.