Regulatory News:
MedinCell (Paris:MEDCL):
Clinical trial validates the safety of ivermectin taken daily in
oral form, to simulate the continuous release of the active
substance by a long-acting injection.
No side effects were observed with the three doses of ivermectin
tested up to 100 µg / kg.
MedinCell develops several long-acting injectable formulations
of ivermectin, the most advanced aims at preventing infection from
Covid-19 and its mutants for several months.
Positive results of the safety study
"All our programs are developed in accordance with the highest
ethical standards and on the basis of reliable scientific
principles with a view to potential massive deployment. Proving the
safety of ivermectin in regular daily administration over a long
period was an essential step for our ivermectin programs, in
particular mdc-TTG in Covid-19," said Joël Richard, Chief
Development Officer at MedinCell.
Ivermectin has already been administered as a once-daily
treatment to hundreds of millions of patients worldwide. Its safety
as a once-daily treatment has been demonstrated and documented.
MedinCell tested ivermectin taken daily in oral form to simulate
the continuous release of the active substance by a long-acting
injectable. After completion, the study confirms the safety of
ivermectin up to a dose of 100 µg / kg / day in continuous
administration over 1 month in healthy volunteers. No significant
difference was observed between the treated volunteers and the
placebo volunteers in the three cohorts studied successively (daily
doses of 50 µg / kg, 75 µg / kg and 100 µg / kg respectively).
The pharmacokinetic data of the three cohorts shows a limited
peak circulating plasma concentration in the first 12 hours (Cmax
between 25-60 ng / mL) and the rapid achievement of a stationary
regime and a regular plasma concentration of between approximately
10 and 30 ng / mL for 28 days, depending on the dose administered.
These preliminary results are considered positive and live up to
Company expectations based on the data in the literature. The
dose-response relationship has not yet been established.
After study completion and in regard of the expert review
conducted by Professor Jacques Descotes1 (March 2021), the safety
profile of ivermectin supports the progress of MedinCell programs
using this molecule, in particular mdc-TTG against Covid-19 and
mdc-STM against malaria.
Covid-19: The prophylactic strategy
"Our hypotheses are being confirmed, says Christophe Douat, CEO
of MedinCell: the pandemic continues, and vaccination may not be
enough to stop it. The body of clinical data and scientific
knowledge supporting the efficacy of ivermectin at a therapeutic
dose against Covid-19, in particular as a prophylaxis, continues to
grow. In this context, our treatment, based on a widely known
molecule, which could be stored at room temperature and which aims
to offer protection for several months after a simple injection
against Covid-19 and its variants, could become a key tool of the
anti-Covid arsenal. Our goal is still to have a product ready in
2022. "
Currently in regulatory development, the mdc-TTG program aims to
offer an injectable treatment in the form of a pre-filled syringe,
ready to use, and stable for 24 months at room temperature.
MedinCell’s BEPO® technology will allow the formation of a small
subcutaneous deposit at the time of injection. It will act as a
mini pump that releases ivermectin regularly until it disappears
completely.
The long-acting formulation of ivermectin in the mdc-TTG program
could provide protection against Covid-19 and its mutants for
several months after a single injection. It could also be
administered to people identified as Covid-19 contact cases to
protect them.
About the clinical safety study
Study title
Exploratory phase 1, randomized,
double-blind trial assessing the pharmacokinetic profile, safety
and tolerability of a regime of continuous daily administration of
Ivermectin to healthy volunteers
Participants
3 successive cohorts of 8 healthy
volunteers (one cohort per dose)
Administration
Daily dose of Ivermectin or placebo taken
orally for 4 weeks by each cohort
Doses tested
Cohort 1: 200 μg/kg (day 1) + 50 μg/kg
daily (day 2 to 28)
Cohort 2: 200 μg/kg (day 1) + 75 μg/kg
daily (Day 2 to 28)
Cohort 3: 200 μg/kg (day 1) + 100 μg/kg
daily (day 2 to 28)
Authorization of clinical trials
MHRA (Medicines & Healthcare products
Regulatory Agency – United Kingdom)
Study period
September 2020 – March 2021
About MedinCell
MedinCell is a clinical stage pharmaceutical 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. 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. Based in Montpellier, MedinCell
currently employs more than 140 people representing over 25
different nationalities.
This press release may contain forward-looking statements,
especially on the Company’s progress of its clinical trials.
Although the Company believes that its expectations are based on
reasonable assumptions, any statements other than statements of
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1 Jacques Descotes, Medical Safety of Ivermectin», March 2021
(www.medincell.com/ivermectin)
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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 / Mathilde Bohin Investor
relations medincell@newcap.eu +33 (0)1 44 71 98 53
NewCap Nicolas Merigeau Media relations medincell@newcap.eu +33
(0)1 44 71 94 98
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