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news.Repligen, a biopharmaceutical company, has initiated a Phase IIb clinical trial to evaluate the use of RG2417, an oral formulation of uridine, in patients with bipolar depression.
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This Phase IIb study is a multi-center, randomized, double-blind, placebo-controlled clinical trial in which approximately 150 patients with bipolar depression will receive either RG2417 or placebo twice daily for eight weeks.
This study is designed to assess the safety and efficacy of RG2417 as measured by the Montgomery-Asberg depression rating scale (MADRS) and the clinical global impression of change in bipolar disorder scale. The study will be conducted at approximately 20 clinical sites within the US.
The trial is designed to confirm and extend the results obtained in a positive Phase IIa clinical trial of RG2417 in which 83 patients with bipolar disorder received either RG2417 or placebo twice daily for six weeks.
The Phase IIa trial demonstrated a statistically significant reduction in the symptoms of depression in patients receiving RG2417 when compared to placebo on the MADRS (p=0.01) and on the CGI-BP-C (p=0.044) over the six-week course of the study.
Walter Herlihy, president and CEO of Repligen, said: “Current therapies used to treat bipolar depression are often ineffective and may have significant side effects, resulting in bipolar depression as an area of high unmet medical need. We look forward to confirming our prior results with RG2417 in bipolar depression in this larger proof-of-concept clinical trial.”