MedinCell’s Long-Acting Injectable to Fight Malaria Ready to Enter Regulatory Development

Regulatory News:

MedinCell (Paris:MEDCL) and the project consortium members, IRD, IRSS and CIRDES, have successfully designed, tested, and confirmed with Unitaid the selection of the lead formulation. Regulatory preclinical activities are starting with the objective of a first clinical trial in 2023.

MedinCell and the consortium members have conducted an in vivo proof of concept on cattle that showed a 3-month mosquitocidal effectiveness of an injectable long-acting formulation of Ivermectin based on the proprietary BEPO technology.

The investigational product mdc-STM aims at reducing the transmission of the parasite responsible for Malaria, thanks to a killing effect on the vector mosquitoes when they bite treated people.

Malaria remains one of the main health threats worldwide with more than 200 million people infected yearly.

In March 2020, global health agency Unitaid granted MedinCell with a $6.4 million subvention over three years to conduct the formulation and preclinical activities of the program.

mdc-STM benefits from synergies with other MedinCell’s programs based on Ivermectin all of them using different formulation and doses fitted to their specific indications.

MedinCell has been collaborating for more than 10 years with IRD, IRSS and CIRDES to conduct in vivo studies in Burkina Faso about tackling residual transmission of Malaria. These partners provide theoretical and practical scientific expertise on malaria and vectors, and the essential field infrastructure to support the demonstration of a 3‑month active injectable ivermectin formulation against malaria vectors. Administered once to exposed populations at the start of the rainy season, which is the period of highest risk of transmission, the investigational product could have a significant impact on malaria incidence and prevalence in Africa where the burden is the highest.

Malaria remains pandemic in 91 countries representing 50% of the world's population. According to WHO estimates, 228 million people were infected worldwide in 2018, 93% of them in Africa, leading to 405,000 deaths. Children under 5 years are the most vulnerable, accounting for 67% of deaths from malaria.

Ivermectin has a long track record of use as a safe and effective drug to treat several parasitic diseases, such as river blindness. Its safety in continuous dosing over 1-month has been demonstrated by a recent randomized placebo-controlled clinical trial sponsored by MedinCell, in which ivermectin was orally administered daily, to simulate the continuous release of the active substance by a long-acting injection. This study and the expert review recently conducted by Pr. Jacques Descotes about the safety profile of ivermectin supports the progress of MedinCell programs using Ivermectin.