Repligen Announces Completion of Patient Enrollment in Phase 2b Clinical Trial of RG2417 for Bipolar Depression
WALTHAM, Mass., Sept. 30 /PRNewswire-FirstCall/ -- Repligen Corporation (Nasdaq: RGEN) reported today that it has completed enrollment of patients in its Phase 2b clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar depression. This study is a double-blind, placebo-controlled trial designed to assess the efficacy of 8 weeks of treatment with RG2417 or a placebo on the symptoms of bipolar depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). The study enrolled 175 patients at 29 clinical sites within the United States, and we expect to report top-line results in the first quarter of 2011.
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 MADRS score of the patients receiving RG2417 when compared to placebo over the 8-week treatment period. Patients were initially screened for a score of bipolar depression symptoms of greater than 20 on the MADRS and subsequently confirmed to meet the criteria for bipolar depression using an alternate diagnostic tool to ensure that patients have the appropriate diagnosis for inclusion in the study. Evaluations for symptoms of depression are conducted at baseline and then weekly using the MADRS, a standardized, rater-administered scale, which has been used for numerous drug trials in bipolar disorder. In addition to the MADRS ratings, patients conduct a weekly self-assessment of their symptoms, which is used to cross check the fidelity of the MADRS raters. 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.
The average baseline MADRS of the 175 patients