The Phase 3 SOLARIS trial, evaluating TEV-749 in adult patients with schizophrenia, has met its primary endpoint by demonstrating clinically meaningful and statistically significant reductions in the Positive and Negative Syndrome Scale (PANSS) total score across all dose groups compared to placebo. TEV-749, utilizing Medincell's SteadyTeq™ technology, offers a controlled steady release of olanzapine, aiming to provide a safer long-acting treatment option without the risk of PDSS, a condition associated with the intramuscular injection of long-acting olanzapine.
Key findings from the trial include:
- Mean differences in change in the PANSS total score from baseline to week 8 were -9.71 points, -11.27 points, and -9.71 points for the high, medium, and low dose groups, respectively, compared to placebo.
- The study also showed statistically significant improvements in key secondary endpoints, including the Clinical Global Impressions – schizophrenia (CGI-S) and Personal and Social Performance Scale (PSP) total scores.
- No cases of PDSS have been reported to date, with additional safety data being collected as part of the long-term follow-up SOLARIS study.
Schizophrenia is a chronic, progressive, and severely debilitating mental disorder affecting approximately 3.5 million people in the U.S. The development of TEV-749 represents a significant advancement in the treatment of schizophrenia, offering a potential new option for patients seeking long-acting injectable treatments with a lower risk of adverse effects.
The SOLARIS study is a multinational, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy, safety, and tolerability of olanzapine extended-release injectable suspension for subcutaneous use in patients with schizophrenia. The trial's positive results underscore the potential of TEV-749 as an innovative treatment option that could improve the lives of patients and their families by providing a more manageable and effective approach to schizophrenia treatment.
Additional efficacy and safety findings from the Phase 3 SOLARIS study are expected to be presented at a medical meeting later this year, with the long-term safety of TEV-749 and incidence of PDSS being further evaluated in the ongoing SOLARIS open-label study.
