The first participants of the SAIVE study have been administered last Friday
SAIVE is a 400-participant, multicenter, randomized, double-blind, placebo-controlled study with an independent Data
Monitoring Committee, conducted in the European Union
Interim data are expected mid 2022
SAIVE aims at validating the efficacy in prophylaxis against Covid-19 of administration of Ivermectin in oral daily form
It is part of MedinCell’s program to develop a subcutaneous injection that could offer more than 3 months of protection against Covid-19 and its variants
SAIVE follows a Phase 1 clinical study conducted by MedinCell that successfully confirmed the safety of daily, oral Ivermectin administration over a long period of time
“We develop this program in accordance with the highest ethical standards and robust scientific principles, far from polemics, said Joël Richard, Chief Development Officer at MedinCell. Ivermectin has many modes of action identified and is not only a broad-spectrum antiparasitic agent. There is favorable data published about the prophylactic efficacy of Ivermectin against Covid-19 that must be confirmed by clinical studies conducted in accordance with regulatory authorities’ standards. Oral daily administration was chosen to simulate the pharmacokinetic profile, i.e. the circulating drug concentration in the blood, from our long-acting injectable formulation. The data from SAIVE will be analyzed by an independent Data Monitoring Committee and will help inform its future development steps.”
MedinCell’s program aims at protecting against Covid-19 with a subcutaneous injection of a long-acting formulation of Ivermectin available in the form of a pre-filled syringe, ready-to-use, with 24-month stability at room temperature. MedinCell’s BEPO® technology will allow the formation of a small subcutaneous depot, fully bioresorbable, at the time of injection. It will act as a biodegradable mini pump that releases Ivermectin regularly until it is completely bio resorbed.
A long-acting injectable formulation of Ivermectin could be an additional tool to protect from Covid-19, especially for nonrespondents to vaccines, such as immunocompromised people and elderlies, and for those with poor access to vaccines or potential treatments.
A more than 3-month active formulation is ready to enter regulatory development.
The safety of the daily administered Ivermectin dose set at 100 μg/kg was validated during a Phase 1 clinical study conducted by
MedinCell (press release: www.medincell.com/en/2021/04/19/clinical-trial-conducted-by-medincell-confirms-the-safety-of-continuousadministration-of-ivermectin/)