MedinCell has reported positive data from the Phase II SAIVE clinical study of ivermectin in preventing Covid-19 infection in a contact-based population.
The double-blind, parallel-group, randomised, placebo-controlled, multicentre trial was designed for assessing the efficacy and safety of ivermectin tablets, which are taken orally for 28 days.
It was conducted between March and November last year in Bulgaria.
The trial was conducted in 399 adult participants who were not vaccinated and were exposed to the virus within five days of screening.
Findings showed that the participants treated with ivermectin had a 72% statistically significant reduction in Covid-19 infection, compared to the placebo group.
During the study, ivermectin given for 28 days showed acceptable tolerability and safety without any safety signals.
The final analysis of the SAIVE clinical trial is planned to be shared later in a peer-reviewed publication.
MedinCell CEO Christophe Douat said: “The SAIVE study provides encouraging data demonstrating efficacy and safety of ivermectin in prevention of Covid-19 infection in a postexposure situation. It supports the development of a long-acting injectable.
“Such a longacting injectable would provide a complementary tool against Covid-19. Several candidate formulations of ivermectin are ready for clinical batch manufacturing to start regulatory preclinical and clinical development.
“We will be reviewing the strategy for this asset based on this top line result and the upcoming comprehensive analysis of the study.”
The company stated that the trial was conducted to support the mdc-TTG programme.
The programme aims to prevent Covid-19 infection for weeks or months through a single injection of a long-acting formulation of ivermectin, which was developed using MedinCell’s BEPO technology.