Phase 3 Data Shows TEV-‘749 Injection Improves Social Function in Schizophrenia

Results from the phase 3 Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS) showed TEV-‘749 significantly improved the social functioning and quality of life in adult patients with schizophrenia.¹

Teva Pharmaceuticals announced this new, positive data on social functioning and quality of life on November 1, 2024, at Psych Congress 2024 in Boston. This adds to the previously announced efficacy results, with Tev-‘749 meeting its primary endpoint: statistically significant mean differences in the change in Positive and Negative Syndrome Scale (PANSS) total scores from baseline to week 8 (P < .0001). Tev-‘749 also demonstrated its safety profile was comparable to other approved oral formulations of olanzapine.

Additionally, Teva presented the findings from 5 other schizophrenia studies, including the real-world analysis of risperidone (UZEDY) which showed high adherence rates in adults with schizophrenia who have unmet social needs including limited education, food security, and experience with poverty.

Findings of the SOLARIS Trial

In SOLARIS, an 8-week, randomized (1:1:1 ratio), double-blind, placebo-controlled, TEV-‘749, a long-acting injectable, brought significant improvement in social functioning and quality of life in patients aged 18 – 64 years with schizophrenia.

The improvement was demonstrated across 3 doses (TEV’749 318 mg, 425 mg, and 531 mg) compared with placebo in the mean difference in change from week 4 to baseline in the Personal and Social Performance Scale (P < .05). The mean difference in change to week 4 was statistically significant for TEV-‘749 318 mg (P < .05) but numerically greater for TEV-‘749 425 mg and 531 mg, compared with placebo.

TEV-‘749 at doses of 318, 425, and 531 mg had significantly greater improvement in Schizophrenia Quality of Life Scores than placebo (P < .05), with mean differences in change from baseline to week 8 of -3.99, -5.39, and -5.65, respectively. Moreover, changes from baseline to week 8 in EuroQoL-5 Dimensions-3 Levels, the exploratory endpoint, were numerically greater at week 8 with TEV-‘749 at the 425 mg dose compared with placebo.

Teva also presented data from vitro studies that compared TEV-‘749 with currently marketed intramuscular olanzapine long-acting injectables for the risk of PDSS and a phase 1 trial evaluating the pharmacokinetic characteristics of TEV-‘749. The trial on pharmacokinetic characteristics showed that the administration route and drug delivery technology may affect the risk of PSS development.

“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,” said Christoph Correll, MD, a psychiatry professor from Zucker School of Medicine, Hempstead, NY, in a statement. “This is an important advancement for those who may benefit from a long-acting treatment approach.”

Results of Real-World Analyses with Risperidone

Real-world analyses revealed high adherence rates of risperidone in 715 adults with schizophrenia who had unmet social needs.

Risperidone, an extended-release injectable for subcutaneous use every 1 to 2 months for the treatment of schizophrenia in adults, was approved by the US Food and Drug Administration (FDA) in April 2023.² Analyzes evaluated social determinants of health and patterns of adherence in adults receiving risperidone.¹

Among the participants, 41% were covered by Medicaid, 8% by Medicare, and 40% by dual coverage. Out of the 189 patients who had available data on SDOH, more than half had low educational attainment, lived in poverty, had food insecurity, and had limited access to healthcare. More than a quarter, but less than half, (44%) were impacted by housing instability.

In total, 69% of participants adhered to risperidone. Despite the high adherence, a lines of therapy analysis showed risperidone was used as a first-line treatment option for 12% of participants. Patients prescribed risperidone often received an oral second-generation antipsychotic first.

“…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,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva, in a statement. “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.”

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). Globe Newswire. November 1, 2024. https://www.globenewswire.com/en/news-release/2024/11/01/2973519/0/en/Teva-Presents-Latest-Schizophrenia-Treatment-Research-Including-Phase-3-SOLARIS-Trial-Results-Demonstrating-Improvements-in-Social-Functioning-and-Quality-of-Life-in-Adults-Receivi.html. Accessed November 5, 2024.}
2. ^{Walter, K. FDA Approves Risperidone for Adults with Schizophrenia. HCPLive. https://www.hcplive.com/view/fda-approves-risperidone-adults-schizophrenia. Accessed November 5, 2024.}