MedinCell Announces Positive Results for the SAIVE Clinical Study in Prevention of Covid-19 Infection in a Contact-Based Population
05 Janeiro 2023 - 5:10PM
Business Wire
Regulatory News:
MedinCell (Paris:MEDCL):
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.”
About MedinCell
MedinCell is a pharmaceutical technology company that develops a
portfolio of long-acting injectable products in various therapeutic
areas by combining its proprietary BEPO® technology with active
ingredients already known and marketed.
U.S. FDA approval for the first product using BEPO® technology
for patients with schizophrenia is expected in H1 2023.
Two other products are in clinical Phase 3. In addition, several
programs should reach the clinic in 2023 and 2024, including two
Global Health initiatives in woman health (contraception) and
malaria, supported by the Bill & Melinda Gates Foundation and
Unitaid respectively.
Through the controlled and extended release of the active
pharmaceutical ingredient, MedinCell makes medical treatments more
efficient, particularly thanks to improved compliance, and to a
reduction in the quantity of medication required. The BEPO®
technology makes it possible to control and guarantee the regular
delivery of a drug at the optimal therapeutic dose for several
days, weeks or months, depending on the product, starting from the
subcutaneous or local injection of a simple deposit of a few
millimeters, fully bioresorbable.
BEPO® biocompatible polymers, the key components of each
MedinCell formulation, are produced and scaled-up at GMP quality
level, and already producible at commercial stage through
MedinCell’s joint-venture with Corbion (Euronext - CRBN).
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. www.medincell.com
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MedinCell David Heuzé Head of Communications
david.heuze@medincell.com +33 (0)6 83 25 21 86
NewCap Louis-Victor Delouvrier/Alban Dufumier Investor Relations
medincell@newcap.eu +33 (0)1 44 71 94 94
NewCap Nicolas Merigeau Media Relations medincell@newcap.eu +33
(0)1 44 71 94 94
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