Initiation of the Phase 3 study for the second long-acting injectable antipsychotic using MedinCell’s technology (program mdc-TJK)
24 Janeiro 2023 - 03:12PM
Business Wire
The Phase 3 study conducted in the U.S. will assess the
efficacy and safety of the first subcutaneous long-acting
Injectable (LAI) formulation of olanzapine for the treatment of
patients with schizophrenia.
MedinCell’s partner Teva, who finances and pilots the
regulatory development of the product (TEV-44749), has just
published details of the study protocol on clinicaltrials.gov
(https://clinicaltrials.gov/ct2/show/NCT05693935?term=Teva&recrs=ab&phase=2&draw=2&rank=9).
Enrollment of the first patients is expected in the coming
days.
mdc-TJK follows mdc-IRM (LAI risperidone), the first
subcutaneous antipsychotic based on MedinCell’s technology
currently under regulatory review by the U.S. FDA, with a launch
target set for H1 2023.
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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version on businesswire.com: https://www.businesswire.com/news/home/20230124005960/en/
MedinCell David Heuzé Head of Communications
david.heuze@medincell.com NewCap Louis-Victor Delouvrier/Alban
Dufumier Investor Relations medincell@newcap.eu NewCap Nicolas
Merigeau Media Relations medincell@newcap.eu
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