Positive SOLARIS Trial Outcome for TEV-‘749: A Monthly Long-Acting Schizophrenia Treatment

Teva Pharmaceuticals and Medincell have reported positive results from the Phase 3 trial of TEV-‘749, a novel treatment for schizophrenia. The study showcased TEV-‘749's efficacy in reducing symptoms of the disorder, as measured by the Positive and Negative Syndrome Scale (PANSS). The treatment, which employs Medincell's proprietary SteadyTeq™ technology for a steady, controlled release of olanzapine, proved to be well-tolerated with no cases of post-injection delirium/sedation syndrome (PDSS) reported.

The trial involved nearly 675 patients who were randomly assigned to receive either a subcutaneous injection of TEV-‘749 or a placebo. The results indicated that all three dosing groups of TEV-‘749 showed significant improvement over placebo, with adjusted P-values of less than 0.001 for each comparison. The primary efficacy endpoint was a change from baseline to week 8 against the PANSS total score. The treatment also demonstrated statistically significant improvements in secondary endpoints.

Schizophrenia, a chronic and debilitating mental disorder, affects an estimated 3.5 million people in the U.S. and is characterized by symptoms such as delusions, hallucinations, and cognitive impairment. Currently, there is no long-acting olanzapine treatment for schizophrenia without the risk of PDSS, a serious side effect associated with intramuscular injections of the medication.

Eric Hughes, Teva's Executive Vice President of Global R&D and Chief Medical Officer, stated that the results are promising for TEV-‘749 as an effective long-acting treatment for schizophrenia. He emphasized Teva's commitment to advancing mental health treatments. Christoph Correll, a professor of psychiatry and the study's co-ordinating investigator, highlighted the importance of developing innovative long-acting treatment options to prevent relapses in patients with schizophrenia.

Christophe Douat, CEO of Medincell, expressed enthusiasm about the partnership with Teva and the potential benefits of their long-acting technology for patients. Additional findings from the SOLARIS study are expected to be presented at a medical conference later in the year, with further safety data anticipated in the second half of 2024.

TEV-‘749 is an investigational monthly subcutaneous injection of olanzapine and is not yet approved for use. The SOLARIS trial is a multinational, multicenter study assessing the efficacy, safety, and tolerability of the treatment in adults with schizophrenia. The study has two phases; the first 8 weeks evaluated efficacy, and the second phase, lasting up to 48 weeks, is assessing long-term safety and PDSS incidence.

Teva Pharmaceutical Industries Ltd. is a global leader in pharmaceuticals, known for its broad portfolio and commitment to innovation and generic medicine development. Medincell is a biopharmaceutical company specializing in developing long-acting injectable drugs across various therapeutic areas, with a focus on improving patient compliance and the effectiveness of treatments.

Schizophrenia is a severe mental disorder affecting cognitive and emotional processes, with a lifetime prevalence of about 1% globally. It typically emerges in late adolescence to early adulthood and is marked by periods of remission and relapse, often necessitating hospitalization. The disorder can lead to significant healthcare costs due to nonadherence to treatment, high discontinuation rates, and repeated hospitalizations.