Gedeon Richter's Cariprazine (RGH-188) drug has demonstrated positive top-line results from the two Phase III clinical trials in patients with acute exacerbation of schizophrenia.
Cariprazine is an orally active, potent dopamine D3-preferring D3/D2 receptor partial agonist, and is under development for the treatment of bipolar depression.
The phase III multinational multicentre double-blind placebo controlled parallel-group fixed-dose study demonstrated the efficacy and safety of Cariprazine, and whether eligible patients met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria and had a Positive And Negative Syndrome Scale (PANSS) total score between 80 and 120 at screening and baseline.
In the fixed-dose trial, a total of 617 patients aged between 18 and 60 years were randomised to treatment arms including 3mg/d Cariprazine, 6mg/d Cariprazine, 10mg/d aripiprazole or placebo given once daily for six weeks.
The protocol-specified primary endpoint includes the change from baseline to week six in the PANSS total score for the individual Cariprazine treatment groups compared to placebo treatment using a mixed-effects model for repeated measures (MMRM) analysis.
PANSS total score was improved at every time point starting at week one for the Cariprazine 6mg/d group and week three onwards for the Cariprazine 3mg/d group, the fixed-dose study showed.
The phase III fixed-flexible dose study is a multinational, multicentre double-blind placebo controlled parallel-group study intended to assess the efficacy and safety of Cariprazine and if patients with acute exacerbation of schizophrenia met the DSM-IV-TR criteria for schizophrenia and had a PANSS total score between 80 and 120 at screening and baseline.
A total of 446 patients between 18 and 60 years old were randomised by the study to one of the following treatment arms: 3-6mg/d Cariprazine, 6-9mg/d Cariprazine, or placebo given once daily for six weeks.
In the fixed-flexible dose trial, the primary endpoint is the change from baseline to week six in the PANSS total score for each Cariprazine treatment group compared to placebo treatment using the MMRM analysis.
The improvement in PANSS total was significant at every time point, starting at week one for the Cariprazine 6-9mg/d group and week two onwards for the Cariprazine 3-6mg/d group.