Under the agreement, Repligen will receive funding for a phase I clinical trial to assess the oral bioavailability of the company’s proprietary formulation of uridine. This phase I study is expected to enroll patients in Q2 2005 and follows Repligen’s preliminary findings in animal models and patients that uridine may be useful in treating the depressive symptoms of bipolar disorder.
“We are very pleased to receive this grant from The Stanley Medical Research Institute, a world leader in the support and development of new drugs for bipolar disorder and schizophrenia,” stated Walter Herlihy, president and CEO of Repligen. “If this study is successful, we look forward to extending this partnership through phase II studies in patients with bipolar disorder.”
In 2004, Repligen completed a six-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.