FDAnews
www.fdanews.com/articles/100911-repligen-reports-positive-phase-iia-results-of-rg2417

Repligen Reports Positive Phase IIa Results of RG2417

November 9, 2007

Repligen reported positive results from a Phase IIa clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar disorder.

In the multicenter study, 84 patients received either RG2417 or placebo twice daily for six weeks. The objective of the study was to assess the safety and efficacy of RG2417 on the symptoms of bipolar depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) and the Clinical Global Impression of Change in Bipolar Disorder scale (CGI-BP-C).

Over the six-week treatment period, patients on RG2417 experienced statistically significant improvement in the symptoms of depression when compared with those taking placebo on the MADRS and a strong trend toward improvement on the CGI-BP-C, Repligen said.