Phase 2b Study of RG2417 for Bipolar Depression

Repligen announced results from its Phase 2b study of RG2417 for bipolar depression. This study was a double-blind, placebo-controlled trial in which 175 patients were enrolled at 29 study sites, and randomized on a 1:1 basis to receive either RG2417 or a placebo twice a day for eight weeks. The primary efficacy endpoint evaluated symptoms of depression. Secondary endpoints included the Clinical Global Impression scale, subset analysis of patients based on prior episodes of depression, responder rates and remission rates.  Study results did not demonstrate a statistically significant improvement in the symptoms of depression in all patients receiving RG2417 when compared to placebo over the eight-week treatment period.

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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