Initiation of the Phase 3 Study for the Second Long-acting Injectable Antipsychotic Using MedinCell’s Technology (Program mdc-TJK)
24 Janeiro 2023 - 2:08PM
Business Wire
Regulatory News:
MedinCell (Paris:MEDCL):
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/20230124005885/en/
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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