Phase 3 SOLARIS Trial Demonstrates Potential of TEV-‘749 in Schizophrenia

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Teva Pharmaceuticals and Medincell shared new results from the efficacy portion of the phase 3 subcutaneous olanzapine extended-release injection study (SOLARIS) trial evaluating TEV-‘749 in adult patients with schizophrenia compared with placebo. TEV-‘749 met its primary endpoint, achieving clinically meaningful and statistically significant reductions across all TEV-‘749 dose groups compared with placebo in the Positive and Negative Syndrome Scale (PANSS) total score from baseline after 8 weeks.¹

TEV-‘749 steadily releases olanzapine—the most prescribed second generation antipsychotic for schizophrenia in the US—via SteadyTeq, which is a copolymer technology proprietary to Medincell.

“These encouraging results from the efficacy portion of our phase 3 SOLARIS trial demonstrate the potential of TEV-‘749 to be an effective long-acting treatment option for schizophrenia and further show our dedication to advancing innovative science in mental health and beyond,” said Eric Hughes, MD, PhD, chief medical officer at Teva. “Schizophrenia can be a devastating disease for both the people struggling with it as well their families. Schizophrenia is often a chronic life-long disease, but by using medication consistently, people can find the treatment help they deserve. This also has the potential to reduce the burden for not only themselves, but their caregivers and loved ones as well.”

SOLARIS—a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study—evaluated the efficacy, safety, and tolerability of TEV-‘749 injectable suspension for subcutaneous use in patients aged 18-65 years with schizophrenia. In period 1 of the study, or the first 8 weeks, approximately 675 patients were randomized to receive a subcutaneous injection of once-monthly TEV-‘749 in a low, medium, or high dose, or placebo in a 1:1:1:1 ratio. In period 2, up to 48 weeks, patients who completed period 1 were randomized and equally allocated to 1 of the 3 TEV-‘749 treatment groups. The end-of-treatment and follow-up visits will be conducted 4 and 8 weeks after the last treatment dose, respectively.

The SOLARIS study’s primary objective was to evaluate the efficacy of TEV-‘749 in adult patients with schizophrenia; key secondary objectives included further evaluating the efficacy of TEV-‘749 based on additional parameters in adult patients with schizophrenia, and evaluating the safety and tolerability of TEV-‘749.

TEV-‘749 met its primary endpoint across all 3 dosing groups, with mean difference in change in PANSS total score from baseline to week 8 of -9.71 points (high dose), -11.27 points (medium dose), and -9.71 points (low dose) versus placebo. Key secondary endpoints of Clinical Global Impressions – schizophrenia and Personal and Social Performance Scale) total score were also statistically significant after adjusting for multiplicity. Long-acting olanzapine treatment options available for schizophrenia carry the risk of postinjection delirium/sedation syndrome (PDSS); however, no cases of PDSS have been reported yet with TEV-‘749, even after administration of approximately 80% of the target injection number.

“These data reinforce the potential of TEV-‘749 as a subcutaneous long-acting injectable by using a proven molecule with an established long-acting delivery system,” said Christoph Correll, MD, professor of psychiatry at the Zucker School of Medicine, Hempstead, NY and SOLARIS study coordinating investigator. “Most patients with schizophrenia will experience one or more relapses throughout their treatment journeys, so I very much welcome the development of new and innovative long-acting treatment options that may better fit into their lives.”

Additional efficacy and safety findings from the SOLARIS study are planned for presentation at a medical meeting later this year. The long-term safety of TEV-‘749 and incidence of PDSS are also being evaluated in the SOLARIS open-label study (period 2) with safety data topline readout expected in the second half of 2024.

"The positive news from the phase III SOLARIS trial continues to encourage ongoing innovation in treatment options for those living with schizophrenia. We are thrilled to be part of this journey with Teva through a strong partnership that allows us to leverage our pioneering long-acting technology for the benefit of patients,” said Christophe Douat, CEO of Medincell.

Another product developed by Teva Pharmaceuticals and Medincell, Uzedy (risperidone) extended-release injectable suspension, which is approved by the US Food and Drug Administration for the treatment of schizophrenia in adults, also uses SteadyTeq technology for controlled, steady release.² 

References

1. Teva and Medincell announce positive phase 3 efficacy results from SOLARIS trial evaluating TEV-‘749 (olanzapine) as a once-monthly subcutaneous long-acting injectable in adults with schizophrenia. News release. May 8, 2024. https://www.businesswire.com/news/home/20240508123809/en/Teva-and-Medincell-Announce-Positive-Phase-3-Efficacy-Results-from-SOLARIS-Trial-Evaluating-TEV-‘749-olanzapine-as-a-Once-Monthly-Subcutaneous-Long-Acting-Injectable-in-Adults-with-Schizophrenia

2. O’Brien E. FDA approves long-acting treatment for schizophrenia in adults. Psychiatric Times. May 1, 2023. https://www.psychiatrictimes.com/view/fda-approves-long-acting-treatment-for-schizophrenia-in-adults