RG2417: Clinical Trials in Bipolar Depression
Repligen is currently conducting a Phase 2b clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar depression. This Phase 2b study is a multi-center, randomized, double-blind, placebo-controlled study in which approximately 150 patients with bipolar depression will receive either RG2417 or a placebo for 8 weeks. Patients will be evaluated for the safety and effectiveness of RG2417 on the symptoms of bipolar depression.
In 2008, Repligen completed a 6-week, Phase 2a clinical trial of a RG2417 in 83 patients with bipolar disorder. The Phase 2a trial demonstrated a statistically significant reduction in the symptoms of depression in patients receiving RG2417 when compared to placebo. The data also demonstrated that RG2417 was safe and well tolerated.
About Bipolar Disorder
Bipolar disorder, also known as manic depression is an illness marked by extreme changes in mood, thought, energy and behavior in which a person's mood can alternate between the "poles" of mania (highs) and depression (lows). Bipolar disorder affects more than two million adults in the United States and is usually diagnosed in late adolescence or early adulthood. Bipolar disorder is a chronic illness associated with substantial morbidity and mortality, ranking worldwide behind only unipolar depression and alcohol abuse among psychiatric illnesses for related disabilities and overall economic burden of illness. The lifetime financial burden of bipolar disorder in the United States is about $625,000 per patient, depending on resistance to treatment and persistence of symptoms. Although lithium and anticonvulsants such as valproic acid have substantially improved the prognosis of bipolar disorder, many individuals are unable to tolerate treatment-related side effects, and incomplete clinical response, relapse, and recurrence remain common clinical problems. For more information about bipolar disorder, please visit the National Institutes of Mental Health's website.
About RG2417 (Uridine) for Neurological Disorders and Neurodegeneration
Uridine is a biological compound essential for the synthesis of DNA, RNA and numerous other factors essential for cell metabolism. Uridine is synthesized by the power plant of the human cell known as the mitochondria. Research indicates that mitochondrial dysfunction is involved in bipolar disorder, which suggests that uridine may be useful in this disease.