Repligen Announces Plans to Initiate a Phase 2b Trial for RG2417 in Bipola...( Reports Full Assessment of Da...),Health

Reports Full Assessment of Data from Positive Phase 2a Trial

WALTHAM, Mass., June 12 /PRNewswire-FirstCall/ -- Repligen Corporation (Nasdaq: RGEN) today announced that based on feedback from the Food and Drug Administration, the Company plans to initiate a Phase 2b clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar disorder later this year. This will be a multi-center, parallel arm placebo-controlled, clinical trial in which approximately 150 patients with bipolar disorder will receive either RG2417 or a placebo twice a day for eight-weeks. This study is designed to assess the efficacy and safety of RG2417 on the symptom of depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). Gary S. Sachs, M.D., founder and director of the Bipolar Clinic and Research Program at the Massachusetts General Hospital and an Associate Professor of Psychiatry at the Harvard Medical School will be the Principal Investigator of this study.

Repligen previously reported positive initial results from a Phase 2a clinical trial of RG2417 in patients with bipolar disorder. We have now completed our assessment of the data and have found that patients with a history of more frequent symptoms demonstrated greater improvements when treated with RG2417 than patients without a history of frequent symptoms. For example, patients with more than 5 episodes of depression over their entire life (n=50) demonstrated greater improvements in their symptoms of depression compared to patients with 5 or fewer lifetime episodes of depression. From weeks 2-6 of treatment, the patients with more than 5 lifetime episodes of depression who received RG2417 had an average improvement on MADRS of 5.5 points over place
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