mdc-TJK has the potential to be the first long-acting injectable of olanzapine with a favorable safety profile
MedinCell’s partner, Teva Pharmaceuticals, highlighted mdc-TJK as one of their three promising late-stage assets poised to accelerate growth during their Investor Day on May 18, 2023 (replay and presentation available here)1
mdc-TJK is the second product developed by Teva based on BEPO® (licensed under the name SteadyTeq™ to Teva), MedinCell’s long-acting injectable technology, which has a proven safety profile as established with UZEDY™ (FDA approved on April 28, 2023)
As announced on May 4, 2023, MedinCell’s partner Teva Pharmaceuticals communicated an original presentation describing pharmacokinetic characteristics of an investigational long-acting subcutaneous formulation of olanzapine (mdc-TJK) at the 2023 Schizophrenia Investigational Research Society (SIRS) on Friday, May 12.
Data came from a 127-participant phase 1 clinical study evaluating, among other things, the pharmacokinetics of single ascending doses of mdc-TJK in healthy volunteers and single and multiple once-monthly doses in patients with schizophrenia or schizoaffective disorder.
mdc-TJK exhibited favorable characteristics of an extended-release profile:
- Reaching clinically relevant therapeutic olanzapine plasma concentrations (≥ 10 ng/mL) within a 1 to 2 day and maintaining them during the 28-day dosing interval
- At steady-state conditions over a 28 dosing interval, the systemic exposure of mdc-TJK at doses 318, 425 and 531 mg were comparable to oral daily corresponding doses 10 mg, 15 mg, and 20 mg respectively
- No burst or uncontrolled rise in olanzapine plasma concentrations following mdc-TKJ subcutaneous administration was observed
The results of this study supported dose selection of mdc-TJK in the ongoing Phase 3.
The phase 3 study is designed to establish both efficacy and safety, including to identify PDSS (post-injection delirium/sedation syndrome) event occurrence. Both MedinCell and Teva believe that BEPO® technology and subcutaneous administration will allow olanzapine LAI to have a favorable safety profile.
Richard Malamut MD, CMO of MedinCell, comments: “We are hopeful that the safety profile of mdc-TJK will be favorable compared to other long-acting injections available for olanzapine. With the long-acting product already available, patients have to be monitored for 3 hours after injection because of risk of PDSS. An improved long-acting injectable of olanzapine could answer a significant unmet medical need.”
“We are very excited to see both UZEDY™ and mdc-TJK highlighted as having the potential to drive long-term growth of Teva at their recent investor day presentation.”, adds Christophe Douat, CEO of MedinCell.
mdc-TJK is the second antipsychotic (following approval of UZEDY™) based on MedinCell’s BEPO® technology. MedinCell is eligible for development milestones, royalties on net sales, and future commercial milestones.