Regulatory News:
MedinCell (Paris:MEDCL):
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
non-respondents 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-continuous-administration-of-ivermectin/)
About the SAIVE study
Study title
SAIVE, A Study to Evaluate the
Efficacy and Safety of Ivermectin in COVID-19 Prevention
Description
A multicenter, randomized,
double-blind, placebo-controlled trial comparing continuous
administration of Ivermectin (in regular, daily, oral form) vs
placebo in the prevention of COVID-19 infection as well as
symptomatic development, in a close-contact population
Participants
400
Administration
Daily oral Ivermectin or placebo
for 4 weeks
Dose
200 µg/kg on Day 1, and then 100
µg/kg/day for Day 2 to Day 28
Primary outcome measure
COVID-19 prophylaxis: proportion
of laboratory-confirmed COVID-19 infections between baseline and
Day 28
About MedinCell
MedinCell is a pharmaceutical company at premarketing stage 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. Through the
controlled and extended release of the active pharmaceutical
ingredient, MedinCell makes medical treatments more efficient,
particularly thanks to improved compliance, i.e. compliance with
medical prescriptions, and to a significant reduction in the
quantity of medication required as part of a one-off or chronic
treatment. 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 starting from the
subcutaneous or local injection of a simple deposit of a few
millimeters, fully bioresorbable. MedinCell collaborate with tier
one pharmaceuticals companies and foundations to improve Global
Health through new therapeutic options. Based in Montpellier,
MedinCell currently employs more than 140 people representing over
25 different nationalities.
www.medincell.com
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MedinCell David Heuzé Head of communication
david.heuze@medincell.com +33 (0)6 83 25 21 86
NewCap Louis-Victor Delouvrier / Olivier Bricaud 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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