Teva Pharmaceuticals has announced positive phase 3 data for TEV-'749, a long-acting injectable, demonstrating significant improvements in social functioning and quality of life for adult patients with schizophrenia. The findings, presented at Psych Congress 2024, build upon previously reported efficacy results showing statistically significant reductions in Positive and Negative Syndrome Scale (PANSS) total scores.
SOLARIS Trial Results
The SOLARIS trial, an 8-week, randomized, double-blind, placebo-controlled study, evaluated TEV-'749 in patients aged 18-64 with schizophrenia. Participants were assigned in a 1:1:1 ratio to receive TEV-'749 at doses of 318 mg, 425 mg, or 531 mg, or placebo.
The study's results indicated a significant improvement in social functioning and quality of life with TEV-'749 compared to placebo. Specifically, the mean difference in change from week 4 to baseline in the Personal and Social Performance Scale (PSP) was statistically significant (P < .05) for the 318 mg dose. While the 425 mg and 531 mg doses showed numerically greater improvements compared to placebo, they did not reach statistical significance at week 4.
Furthermore, TEV-'749 at all three doses (318, 425, and 531 mg) demonstrated significantly greater improvement in Schizophrenia Quality of Life Scores (SQLS) than placebo (P < .05). The mean differences in change from baseline to week 8 were -3.99, -5.39, and -5.65, respectively. An exploratory endpoint, changes from baseline to week 8 in EuroQoL-5 Dimensions-3 Levels, were numerically greater at week 8 with TEV-'749 at the 425 mg dose compared with placebo.
Additional Findings and Risperidone Adherence
Teva also presented data from in vitro studies comparing TEV-'749 with currently marketed intramuscular olanzapine long-acting injectables regarding the risk of Post-injection Delirium/Sedation Syndrome (PDSS). A phase 1 trial evaluating the pharmacokinetic characteristics of TEV-'749 suggested that the administration route and drug delivery technology could influence the risk of PDSS 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 separate analysis of risperidone (UZEDY), a real-world study involving 715 adults with schizophrenia revealed high adherence rates. The analysis evaluated social determinants of health and adherence patterns in adults receiving risperidone. Results showed that 69% of participants adhered to risperidone, despite many facing social challenges such as low educational attainment, poverty, food insecurity, and limited access to healthcare.
"...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.
