Teva said Wednesday morning that its schizophrenia drug succeeded in a Phase 3 trial with signs of a differentiated safety profile versus standard of care.
The Phase 3 SOLARIS trial set TEV-‘749 — a once-monthly subcutaneous version of atypical antipsychotic olanzapine — against placebo in adults with schizophrenia. The drug, which is being developed by Teva, is delivered using Medincell’s extended release technology.
TEV-‘749 met the trial’s primary endpoint of statistically significant reductions in the Positive and Negative Syndrome Scale (PANSS) total score versus placebo at eight weeks, according to a press release. The drug also hit key secondary endpoints, including Clinical Global Impressions – schizophrenia (CGI-S) total score and Personal and Social Performance Scale (PSP) total score “after adjusting for multiplicity.”
The candidate has no post-injection delirium/sedation syndrome (PDSS) seen to date. There are no long-acting olanzapine treatments available for schizophrenia that do not come with a risk of PDSS, which is characterized by sudden and unexpected delirium or sedation within the first few hours of getting treatment, Teva said.
In November, Teva inked a deal with Royalty Pharma in which it could receive $100 million to complete SOLARIS, with the partners having the option to raise that amount to $125 million. The Israeli company is set to pay Royalty back within five years of FDA approval, plus low- to mid-single digit royalties.
As for Medincell, the French biotech’s long-acting injectable technology was recently the subject of an April deal with AbbVie involving $35 million upfront. The agreement includes up to $1.9 billion in milestones and is focused on the development of up to six preclinical LAI programs across different therapeutic areas.