Teva Shares Positive Phase III Data of Schizophrenia Injectable TEV-'749
Results showed significantly improved social functioning and quality of life across three different doses.
Teva has shared results from the Phase III SOLARIS (NCT05693935) clinical trial of TEV-'749 in adult patients diagnosed with schizophrenia. The subcutaneous long-acting injectable demonstrated significant improvements in social functioning and quality of life among participants. Additional findings from the study were presented at Psych Congress 2024 in Boston, MA.1
In a press release, Eric Hughes, MD, PhD, executive vice president of global R&D and chief medical officer at Teva said, “For people living with schizophrenia receiving treatment, outside of symptom control, potential improvements in social functioning and quality of life are of fundamental importance, so we are delighted to share these encouraging TEV-'749 results. Similarly, the real-world studies evaluating UZEDY will help enable healthcare professionals to better understand the impact of unmet social needs—like housing instability and food insecurity—may have on people living with schizophrenia and their treatment. These efforts reflect Teva’s continued commitment to help address the needs of people living with schizophrenia, as we continue to center our research on the patient.”
The SOLARIS study is comprised of two parts. Period 1, which this new data emerged from, is an 8-week, randomized, double-blind, placebo-controlled trial in patients aged 18-64 years. Period 2 is an open-label safety period of up to 48 weeks.
In Period 1, three different doses (318 mg, 425 mg, and 531 mg) of TEV-'749 were evaluated. Across all of them, the injectable significantly improved social functioning and quality of life by week 8 compared to placebo.
Christoph Correll, MD, professor of psychiatry at the Zucker School of Medicine, Hempstead, NY added, “My patients with schizophrenia have a wide range of social backgrounds and experiences, so it’s important that healthcare professionals are able to consider real-world data that incorporate these aspects of life as we consider appropriate treatment options like UZEDY. In regard to TEV-'749 and the potential lack of PDSS, we may soon be able to offer schizophrenia treatment for patients taking daily oral olanzapine with a long-acting injectable option that may reduce the risk of this potentially life-threatening side effect. This is an important advancement for those who may benefit from a long-acting treatment approach.”
Earlier in September, Teva shared positive efficacy, safety, and tolerability results from SOLARIS. TEV-'749 met the primary endpoint, displaying significant improvements in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 8.2
In an earlier press release, Correll said, “Developing a long-acting olanzapine formulation that poses potentially no risk of PDSS is crucial in preventing these dangerous episodes that otherwise limit the use of olanzapine to daily oral options. With no PDSS observed in the SOLARIS trial to date, these data add to the growing body of evidence that TEV-‘749 may one day serve as an important treatment option for patients and healthcare providers who rely on olanzapine and also have needs or preferences that require a long-acting option.”
References
1. Teva Presents Latest Schizophrenia Treatment Research, Including Phase 3 SOLARIS Trial Results Demonstrating Improvements in Social Functioning and Quality of Life in Adults Receiving TEV-'749 (olanzapine) a Subcutaneous Long-Acting Injectable as well as Results of Real-World Analyses of UZEDY® (risperidone). News release. Teva. November 1, 2024. Accessed November 4, 2024. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2024/Teva-Presents-Latest-Schizophrenia-Treatment-Research-Including-Phase-3-SOLARIS-Trial-Results-Demonstrating-Improvements-in-Social-Functioning-and-Quality-of-Life-in-Adults-Receiving-TEV-749-olanzapine-a-Subcutaneous-Long-Acting-Injectable-as-well-as/default.aspx
2. Teva Presents New Phase 3 Efficacy, Safety and Tolerability Data from SOLARIS Trial Evaluating TEV-‘749 (olanzapine) as a Once-Monthly Subcutaneous Long-Acting Injectable for Adult Patients Diagnosed with Schizophrenia. News release. Teva. September 21, 2024. Accessed November 4, 2024. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2024/Teva-Presents-New-Phase-3-Efficacy-Safety-and-Tolerability-Data-from-SOLARIS-Trial-Evaluating-TEV-749-olanzapine-as-a-Once-Monthly-Subcutaneous-Long-Acting-Injectable-for-Adult-Patients-Diagnosed-with-Schizophrenia/default.aspx
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