Teva's Long-Acting Schizophrenia Drug Achieves Key Study Goal

Teva Pharmaceuticals has announced promising results from a Phase III clinical trial evaluating its long-acting formulation of the antipsychotic drug olanzapine, known as TEV-'749, for adults with schizophrenia. These positive outcomes seem to affirm Royalty Pharma's recent investment in this once-monthly treatment. The findings also support Teva's decision to secure external funding to expedite the drug's development, having initially anticipated data from the SOLARIS trial in the latter half of the year.

The clinical study commenced with the randomisation of 675 adults diagnosed with schizophrenia, who received either a subcutaneous injection of TEV-'749 at varying doses or a placebo for an 8-week period. Participants who successfully completed this phase were then re-randomised to one of the TEV-'749 doses for an extended duration of up to 48 weeks.

Currently, Eli Lilly offers olanzapine in a once-daily oral form under the brand name Zyprexa. However, Teva has highlighted that other long-acting versions of olanzapine pose a risk of post-injection delirium/sedation syndrome (PDSS). Earlier this year, Teva’s CEO Richard Francis emphasized TEV-'749 as a crucial element of the company's growth strategy.

The SOLARIS study results demonstrated that TEV-'749 successfully met its primary endpoint, as evidenced by a significant and clinically meaningful reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to the placebo. Specifically, the mean difference in PANSS score from baseline to week 8 was -9.71 points, -11.27 points, and -9.71 points for the high, medium, and low dose groups of TEV-'749, respectively.

In addition to meeting the primary endpoint, TEV-'749 also achieved statistical significance in key secondary endpoints, including the Clinical Global Impressions – schizophrenia (CGI-S) and the Personal and Social Performance Scale (PSP) total score, after adjusting for multiplicity. Crucially, TEV-'749 was well tolerated by patients, with no reported cases of PDSS following the administration of approximately 80% of the target number of injections.

Further results from the SOLARIS trial will be disclosed at an upcoming medical conference later this year. Additional top-line data focusing on long-term safety and the incidence of PDSS are expected by the year's second half. TEV-'749 represents the second product developed by Teva using MedinCell's copolymer technology, SteadyTeq, which facilitates the sustained release of olanzapine at therapeutic levels over a month-long dosing interval.

Overall, these findings provide a strong foundation for the continued development and potential future approval of TEV-'749, offering a new, long-acting therapeutic option for adults with schizophrenia. The successful outcomes from the SOLARIS study not only validate the drug's efficacy and safety profile but also highlight the potential advantages of a monthly dosing regimen, thus contributing to Teva's strategic growth in the pharmaceutical landscape.