MedinCell: mdc-TJK's (Teva's codename: TEV-44749) Phase 1 study pharmacokinetics to be presented for the first time by Teva at SIRS 2023 (May 11-15, 2023, Toronto, Canada)
04 Maggio 2023 - 6:26PM
Business Wire
An original presentation describing pharmacokinetic
characteristics of an investigational long-acting subcutaneous
formulation of olanzapine (mdc-TJK or TEV-44749) will be
communicated by MedinCell’s partner Teva Pharmaceuticals at the
2023 Schizophrenia Investigational Research Society (SIRS) later
this month.
Data to be presented comes from a 127-participant phase 1
clinical study evaluating, among other things, the pharmacokinetics
of single ascending doses of mdc-TJK (TEV-44749) in healthy
volunteers and single and multiple once-monthly doses in patients
with schizophrenia or schizoaffective disorder. After injection,
mdc-TJK (TEV-44749) reached a therapeutic concentration within a
day and maintained it throughout the 28-day dosing interval.
mdc-TJK (TEV-44749) is the second antipsychotic based on
MedinCell’s BEPO® technology. The pharmacokinetic analysis to be
presented at SIRS informed the doses of the pivotal Phase 3
clinical study initiated in January 2023 by Teva. MedinCell is
eligible for development milestones, royalties on net sales, and
future commercial milestones.
“These findings confirm the power of our technology to reach
targeted therapeutic profile, said Christophe Douat, CEO of
MedinCell. Now we are awaiting the safety and efficacy results of
the ongoing Phase 3 study. If favorable, they may allow patients
with schizophrenia to finally benefit from an easy-to-use
olanzapine long-acting injectable treatment. It remains a huge
unmet medical need for patients with more severe symptoms of
schizophrenia.”
MedinCell and Teva announced on April 28th, 2023 that UZEDY™,
the first product based on MedinCell’s proprietary BEPO technology
(licensed to Teva under the name SteadyTeq™) obtained U.S. FDA
approval and will be available for schizophrenia patients in the
coming weeks. Several presentations related to studies that
supported the regulatory development and the approval of UZEDY will
also be communicated at SIRS 2023 by Teva.
UZEDY and mdc-TJK (TEV-44749) are part of MedinCell’s growing
portfolio that includes other breakthrough treatments, all of which
aim at offering innovative therapeutic options that may ensure
patient adherence and provide other benefits that address unmet
medical need.
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MedinCell David Heuzé Head of Communications
david.heuze@medincell.com +33 (0)6 83 25 21 86
NewCap Alban Dufumier / Louis-Victor Delouvrier 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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