Phase 2b study of RG2417 for the treatment of bipolar depression

Repligen reported that it has completed enrollment of patients in its Phase 2b clinical trial of RG2417 in patients with bipolar depression. This study is a double-blind, placebo-controlled trial with 175 patients at 29 clinical sites throughout the United States. The primary objective of this study is to assess the safety and efficacy of RG2417 on the symptoms of bipolar depression by demonstrating a greater improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) score of the patients receiving RG2417 when compared to placebo over the 8-week treatment period.  Additional secondary and exploratory objectives include improvements in the Clinical Global Impression Scale, difference in the end of study MADRS scores, and a lack of increase in mania as measured by the Young’s Mania Rating Scale.

RG2417 is an oral formulation of uridine, a molecule that is one of the four basic components of ribonucleic acid (RNA).  

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