In this multi-center, dose escalating study, 80 patients will receive either RG2417 or a placebo for six weeks. Patients will be evaluated for the safety and effectiveness of RG2417 on the symptoms of bipolar depression. The study is being conducted under a development agreement with the Stanley Medical Research Institute, from whom Repligen will receive funding.
“Bipolar depression is a serious chronic illness and treatment is challenging due to the potential for induction of mania, a common side effect of standard treatment with antidepressants,” said Walter Herlihy, president and CEO of Repligen. “If this proof of principle study shows evidence that RG2417 improves the symptoms of bipolar depression without inducing mania, it has the potential to be an important new therapy in an area of significant unmet medical need.”
Repligen previously completed a 6-week phase I clinical trial of a prodrug of uridine (RG2133) in patients with bipolar disorder or major depression. The results demonstrated that administration of RG2133 in this patient population appeared to be safe, did not induce mania, and provided early evidence of a clinical effect of the drug.
Uridine is a biological compound essential for the synthesis of DNA and RNA, the basic hereditary material found in all cells, and numerous other factors essential for cell metabolism. Uridine is synthesized by the power plant of the human cell known as the mitochondria. The rationale for uridine therapy in neuropsychiatric disorders is supported by preclinical and clinical research.