Teva and Medincell Report Positive Phase 3 Results for Monthly Injectable Schizophrenia Treatment

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., in partnership with Medincell, has announced positive results from the Phase 3 Subcutaneous OLAnzapine extended-Release Injection Study (SOLARIS) trial for TEV-‘749. This study is focused on evaluating TEV-‘749 in adult patients with schizophrenia. The results have shown that TEV-‘749 met its primary endpoint, achieving significant reductions in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo.

TEV-‘749, developed by Teva, is a once-monthly subcutaneous long-acting injection of olanzapine, utilizing Medincell's SteadyTeq™ technology. This proprietary copolymer technology ensures a controlled release of olanzapine, a widely prescribed second-generation antipsychotic in the U.S.

In the study, TEV-‘749 showed meaningful and statistically significant improvements in PANSS total score from baseline to week 8. The changes were -9.71 points, -11.27 points, and -9.71 points for high, medium, and low dose groups, respectively, all with adjusted P-values of less than 0.001. Key secondary endpoints, including the Clinical Global Impressions – schizophrenia (CGI-S) and Personal and Social Performance Scale (PSP) total score, were also statistically significant after adjusting for multiplicity. Importantly, no cases of post-injection delirium/sedation syndrome (PDSS) have been reported so far.

Schizophrenia, a chronic and severely debilitating mental disorder, affects approximately 3.5 million people in the U.S. It disrupts how individuals think, feel, and behave. Currently, there is no long-acting olanzapine treatment for schizophrenia that does not carry the risk of PDSS, a sudden onset of delirium or sedation following treatment. PDSS has been linked to intramuscular injections of long-acting olanzapine, making the results of this study particularly significant.

Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva, highlighted the significance of these findings, noting the potential of TEV-‘749 as an effective long-acting treatment option for schizophrenia. He emphasized the chronic nature of schizophrenia and the importance of consistent medication to manage the disease, potentially easing the burden on patients and their caregivers.

The PANSS is a comprehensive tool used to assess schizophrenia symptoms, encompassing Positive Scale, Negative Scale, and General Psychopathology Scale. Each item is rated from 1 to 7, with higher scores indicating greater severity. The primary efficacy endpoint of the SOLARIS study was based on the change in PANSS total score from baseline to week 8.

Christoph Correll, MD, Professor of Psychiatry at the Zucker School of Medicine and co-ordinating investigator for the SOLARIS study, expressed optimism about the development of long-acting treatment options for schizophrenia. He noted that most patients experience multiple relapses, underscoring the need for innovative treatments like TEV-‘749.

Christophe Douat, CEO of Medincell, echoed this sentiment, highlighting the importance of continued innovation in treatment options for schizophrenia. He emphasized the strong partnership between Medincell and Teva, which leverages pioneering long-acting technology for patient benefit.

Further efficacy and safety findings from the SOLARIS study will be presented at a medical meeting later this year. The long-term safety and incidence of PDSS are also being evaluated in the ongoing SOLARIS open-label study, with data expected in the second half of 2024.

TEV-‘749 remains investigational and is not yet approved by any regulatory authority. The SOLARIS study aims to provide comprehensive data on the efficacy, safety, and tolerability of this potential new treatment for schizophrenia.