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
- The study met its primary endpoint achieving clinically meaningful and statistically significant reductions across all TEV-‘749 dose groups versus placebo in the Positive and Negative Syndrome Scale (PANSS) total score, a widely used assessment tool for schizophrenia symptom severity
- TEV-‘749 was well tolerated, with no incidence of post-injection delirium/sedation syndrome (PDSS) observed to date: additional safety data is being collected as part of the long-term follow-up SOLARIS study
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TEV-‘749 is being developed by Teva as a once-monthly subcutaneous long-acting injection of olanzapine with the use of SteadyTeq™ technology, a copolymer technology proprietary to
Medincell
TEV-‘749 met its primary endpoint across all three dosing groups, with mean difference in change in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 8 of -9.71 points, -11.27 points, and -9.71 points versus placebo for the high, medium, and low dose groups, respectively. These differences from placebo were clinically meaningful and statistically significant with adjusted P-values of <0.001 for each comparison. Key secondary endpoints of CGI-S (Clinical Global Impressions – schizophrenia) and PSP (Personal and Social Performance Scale) total score were also statistically significant after adjusting for multiplicity. No cases of PDSS have been reported to date, after administration of approximately 80% of the target injection number.
An estimated 3.5 million people are currently diagnosed with schizophrenia in the
“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
The PANSS is composed of 3 subscales: Positive Scale, Negative Scale, and General Psychopathology Scale. Each subscale is rated with 1 to 7 points ranging from absent to extreme. Each of the 30 items is accompanied by a specific definition as well as detailed anchoring criteria for all seven rating points. These seven points represent increasing levels of psychopathology, as follows: 1- absent 2- minimal 3- mild 4- moderate 5- moderate severe 6- severe 7- extreme; the PANSS overall total score ranges from 30 to 210, with a higher score indicating greater symptom severity. The primary efficacy endpoint was measured by change from baseline to week 8 against the PANSS total score.
“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
"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
Additional efficacy and safety findings from the Phase 3 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.
TEV-‘749 is an investigational once-monthly subcutaneous long-acting injection of the 2nd generation antipsychotic olanzapine and is not approved by any regulatory authority for any use and its safety and efficacy are not established.
About Subcutaneous OLAnzapine Extended-Release Injection Study (SOLARIS)
SOLARIS is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety, and tolerability of olanzapine extended-release injectable suspension for subcutaneous use as a treatment in patients (ages 18-65 years) with schizophrenia. For period one of the study (first 8 weeks), 675 patients were randomized to receive a subcutaneous injection of once-monthly TEV-‘749 (low, medium or high dose) or placebo in a 1:1:1:1 ratio. For period two, which will last for up to 48 weeks, patients who completed period one were randomized and equally allocated to one of the three TEV-‘749 treatment groups. The end-of-treatment and follow-up visits will be at 4 and 8 weeks after administration of the last treatment dose, respectively. The primary objective of the Phase 3 SOLARIS study was to evaluate the efficacy of TEV-‘749 in adult patients with schizophrenia. A key secondary objective was to further evaluate the efficacy of TEV-‘749 based on additional parameters in adult patients with schizophrenia. A secondary objective that is still ongoing through period two of the study is to evaluate the safety and tolerability of TEV-‘749 in adult patients with schizophrenia.
About Schizophrenia
Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts.2 Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability.2,3,4 Approximately 1% of the world’s population will develop schizophrenia in their lifetime, and 3.5 million people in the
About Teva
About
Note: TEV-‘749 is referenced as mdc-TJK in Medincell’s documentation and corporate website.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop olanzapine LAI (TEV-‘749) for the treatment of adults with schizophrenia; our ability to achieve successful results from the efficacy portion of the Phase 3 trial for olanzapine LAI (TEV-‘749); our ability to achieve successful results from the safety portion of the Phase 3 trial for olanzapine LAI (TEV-‘749); our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generic medicines; the effectiveness of our patents and other measures to protect our intellectual property rights; and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2024, and in our Annual Report on Form 10-K for the year ended
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1 NPA TRx - MAT
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3 Velligan DI, Rao S. The epidemiology and global burden of schizophrenia. J Clin Psychiatry. 2023;84(1):MS21078COM5. https://doi.org/10.4088/JCP.MS21078COM5.
4 Wander C. (2020). Schizophrenia: opportunities to improve outcomes and reduce economic burden through managed care. The American journal of managed care, 26(3 Suppl), S62–S68. https://doi.org/10.37765/ajmc.2020.43013
5 Emsley, R., & Kilian, S. (2018). Efficacy and safety profile of paliperidone palmitate injections in the management of patients with schizophrenia: an evidence-based review. Neuropsychiatric disease and treatment, 14, 205–223.
6 Emsley, R., Chiliza, B., Asmal, L. et al. (2013) The nature of relapse in schizophrenia. BMC Psychiatry 13, 50.
7 Andreasen, N. C., et al. (2013). Relapse duration, treatment intensity, and brain tissue loss in schizophrenia: a prospective longitudinal MRI study. The American journal of psychiatry, 170(6), 609–615.
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