Positive efficacy results reported in phase 3 study of schizophrenia injectable

Key takeaways:

• Tev-‘749 is a subcutaneous injectable for adults with schizophrenia.
• Long-term safety will be evaluated in the SOLARIS open-label study, with data expected in the second half of 2024.

Teva Pharmaceuticals and Medincell have announced positive efficacy results from the phase 3 SOLARIS clinical trial evaluating an investigational, monthly subcutaneous injectable in adults with schizophrenia.

According to a joint press release, results showed that Tev-‘749 met its primary

endpoint as measured by a change in the Positive and Negative Syndrome Scale (PANSS) total score in the multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study that evaluated safety, efficacy and tolerability of olanzapine extended-release injectable suspension for subcutaneous administration.

In the study’s first interval, 675 individuals were randomized on a 1:1:1:1 basis to receive a subcutaneous injection of once-monthly Tev-‘749 (low, medium or high dose) or placebo for 8 weeks.

The primary endpoint was met across all three dosing groups, with mean difference in PANSS change from baseline to week 8 of -9.71 points, -11.27 points, and -9.71 points for each group, respectively, compared to placebo.

Key secondary endpoints of CGI-S Clinical Global Impressions – schizophrenia (CGI-S) and Personal and Social Performance Scale total score were also statistically significant. No cases of post-injection delirium/sedation syndrome have been reported to date, after administration of approximately 80% of the target injection number.

Tev-‘749 utilizes SteadyTeq, Medincell’s proprietary copolymer technology, developed to provide a controlled steady release of olanzapine, per the release.

“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,” Eric Hughes, MD, PhD, executive vice president of global research and development and chief medical officer at Teva, said in the release.

Teva and Medincell additionally stated that further efficacy and safety findings from SOLARIS are expected to be presented at a meeting to be determined later this year.