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.