Teva Pharmaceuticals, the U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), has announced encouraging new data from the Phase 3 SOLARIS trial on TEV-‘749, a subcutaneous extended-release injection for schizophrenia. In the study’s acute treatment phase (Period 1), TEV-‘749 significantly improved social functioning and quality of life in adults with schizophrenia, as measured by multiple validated scales over eight weeks. The safety profile of TEV-‘749 was consistent with existing oral olanzapine formulations, showing no new safety concerns and no reports of post-injection delirium/sedation syndrome (PDSS). The data, along with early Phase 1 results on TEV-‘749’s pharmacokinetics, were presented at the 2024 Psych Congress held October 29 – November 2 in Boston, MA.
Schizophrenia, a complex condition that impacts quality of life and social interactions, may benefit from treatments like TEV-‘749 that address these aspects directly. “For people living with schizophrenia, improving social functioning and quality of life beyond symptom control is essential,” said Dr. Eric Hughes, Executive Vice President of Global R&D and Chief Medical Officer at Teva. “Additionally, real-world studies on UZEDY® are helping healthcare professionals understand the social challenges faced by people with schizophrenia, such as housing instability and food insecurity. These studies underscore Teva’s commitment to meeting patient needs.”
The SOLARIS trial includes an initial eight-week, randomized, double-blind, placebo-controlled phase (Period 1), followed by a 48-week open-label safety phase (Period 2). Results from the acute phase indicated:
- Social Functioning: The Personal and Social Performance Scale scores improved significantly from baseline to week 8 for TEV-‘749 doses (318mg, 425mg, and 531mg) compared to placebo (p < 0.05). Statistically significant improvements were also noted by week 4 for the 318mg dose.
- Quality of Life: Scores on the Schizophrenia Quality of Life Scale improved significantly at all doses by week 8, with changes of -3.99 (318mg), -5.39 (425mg), and -5.65 (531mg) compared to placebo (p < 0.05).
- Additional Quality Measures: TEV-‘749 425mg showed improvements in the EuroQoL-5 Dimensions-3 Levels, an exploratory quality-of-life measure, compared to placebo.
Previously reported efficacy data from SOLARIS also showed that TEV-‘749 significantly reduced PANSS (Positive and Negative Syndrome Scale) scores across all doses by week 8, meeting the study’s primary endpoint (p < 0.0001). TEV-‘749’s safety profile aligns with other approved oral olanzapine formulations, and no PDSS cases have been reported.
Teva additionally presented findings from in vitro studies and Phase 1 data, confirming TEV-‘749’s controlled-release properties, with no burst release of olanzapine upon plasma contact, potentially reducing PDSS risks. “Given the diverse social backgrounds of patients with schizophrenia, real-world data on treatments like UZEDY and investigational options like TEV-‘749 help us consider these aspects in treatment plans,” noted Dr. Christoph Correll, Professor of Psychiatry at the Zucker School of Medicine.
Teva also reported real-world analyses on UZEDY (risperidone), its extended-release injectable risperidone for adults with schizophrenia. Approved by the FDA in April 2023, UZEDY has shown high adherence rates and offers insights into unmet social needs among patients:
- Patient Demographics: Among UZEDY users, 41% were covered by Medicaid, 8% by Medicare, and 40% had dual coverage.
- Social Determinants of Health: Among 189 patients with SDOH data, many faced low educational attainment, poverty, food insecurity, limited healthcare access, and housing instability (44%).
- Adherence: 69% achieved high adherence (≥80% days covered), with UZEDY commonly used after second-generation oral antipsychotics.
TEV-‘749, an investigational once-monthly subcutaneous formulation of olanzapine, is not yet approved for any use. Its safety and efficacy remain under investigation.
