MedinCell collaborates with tier one pharmaceuticals companies and foundations to improve Global Health through innovative therapeutic options.
Based in Montpellier, MedinCell is a public company (Euronext, MEDCL), currently employing 150 people from over 30 different nationalities.
January 6, 2023
MedinCell Announces Positive Results for the SAIVE Clinical Study in Prevention of Covid-19 Infection in a Contact-Based Population
MONTPELLIER, France, January 05, 2023–(BUSINESS WIRE)–Regulatory News:
The study conducted in 399 participants met its primary efficacy endpoint with a reduction of 72% of COVID-19 infection in the group treated with daily oral administration of ivermectin compared to the placebo group
Ivermectin administered for 28 days demonstrated acceptable safety and tolerability without any unexpected safety signals
The SAIVE study was conducted to support mdc-TTG program, whose objective is to provide prevention of Covid-19 infection for weeks or months with a single injection of a long-acting formulation of ivermectin based on MedinCell’s proprietary technology, BEPO®
Note: this publication is not a recommendation to use ivermectin against Covid-19.
The SAIVE Trial (NCT 05305560) is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical study, evaluating the safety and efficacy of ivermectin tablets taken orally for 28 days, under the oversight of a U.S. based independent Data Monitoring Committee. The study was conducted in Bulgaria between March and November 2022.
All participants were unvaccinated adults and had been exposed to the virus within 5 days of screening after documented close contact with a person who had a PCR-confirmed SARS-CoV-2 infection.
Participants randomized to ivermectin group showed a highly statistically significant reduction (72%) of laboratory-confirmed infections between baseline and Day 28 (30/200) versus placebo (105/199), the study’s primary endpoint, with p<0,0001.
No safety signals related to daily intake of ivermectin, 200 microgram/kg on Day 1 then 100 microgram/kg daily from Day 2 to Day 28 were identified during the study.
The company plans to share the final analysis of the study in a peer-reviewed publication at a later date.
The SAIVE study provides encouraging data demonstrating efficacy and safety of ivermectin in prevention of Covid-19 infection in a post-exposure situation. It supports the development of a long-acting injectable, said Christophe Douat, CEO of MedinCell. Such a long-acting 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.”