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news.Repligen has announced that, based on feedback from the FDA, the company plans to initiate a Phase IIb clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar disorder, later in 2008.
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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.
The Phase IIb 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 Sachs, founder and director of the Bipolar Clinic and Research Program at the Massachusetts General Hospital, will be the principal investigator of this study.
Walter Herlihy, president and CEO of Repligen, said: “The safety and efficacy results of our previous study of RG2417 strongly support further evaluation in patients with bipolar disorder. We are very pleased to have someone with Gary’s expertise to lead the next phase of our clinical development program.”