Teva’s long-acting schizophrenia drug hits main goal of pivotal study
08 May 2024
Clinical ResultPhase 3
Teva’s long-acting formulation of the atypical antipsychotic olanzapine met the primary endpoint of a Phase III study in adults with schizophrenia, appearing to justify Royalty Pharma’s recent bet on the once-monthly treatment. The positive results also support Teva’s move to bring in external funding to accelerate development of the therapy, dubbed TEV-'749, having previously not expected data from the SOLARIS trial until the second half.
The study initially randomised 675 adults with schizophrenia to receive a subcutaneous injection of TEV-‘749 at one of three once-monthly doses or placebo for 8 weeks. Patients who complete this portion of the trial are then randomised to receive one of the doses of TEV-‘749 for up to a further 48 weeks.
Eli Lilly currently markets olanzapine in a once-daily oral formulation as Zyprexa, while Teva noted that other long-acting versions of the therapy carry a risk of post-injection delirium/sedation syndrome (PDSS). Richard Francis, chief executive of the Israeli drugmaker, highlighted TEV-‘749 earlier this year as one of several assets key to its growth strategy.
No incidence of PDSS
Results from SOLARIS demonstrated that TEV-‘749 met its primary endpoint as measured by a clinically meaningful and statistically significant change in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo. Teva said that the mean difference from baseline to week 8 was -9.71 points, -11.27 points and -9.71 points versus placebo for the high, medium and low TEV-‘749 dose groups, respectively.
Meanwhile, Teva noted that key secondary endpoints of Clinical Global Impressions – schizophrenia (CGI-S) and Personal and Social Performance Scale (PSP) total score were also statistically significant after adjusting for multiplicity. The company added that TEV-‘749 was well tolerated, with no incidence of PDSS observed after administration of approximately 80% of the target injection number.
Further results from SOLIRIS will be presented at a medical meeting later this year, while top-line data on long-term safety and the incidence of PDSS are expected in the second half. TEV-‘749 is the second product developed by Teva that uses MedinCell's copolymer technology SteadyTeq, which allows for sustained release of olanzapine at a therapeutic dose over the full one-month dosing interval.
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