Repligen Corporation has announced that it has exclusively licensed worldwide rights for the use of uridine in the treatment of patients with bipolar disorder from McLean Hospital.
The use of uridine in the treatment of patients with bipolar disorder is currently the subject of a patent application and upon issue, the patent will remain in force until 2025 prior to any regulatory extensions. Under the terms of the license agreement, McLean will receive an upfront payment, development milestones and royalties upon successful commercialization of uridine for bipolar disorder. McLean Hospital is the largest psychiatric facility of Harvard Medical School and maintains the largest research program of any private, U.S. psychiatric hospital. Repligen is developing RG2417, an oral formulation of uridine, as a treatment for the depressive symptoms of bipolar disorder based on positive results of a previously reported Phase 2a clinical trial.
"Bipolar disorder affects more than two million adults in the United States," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. "Treatment of the symptoms of bipolar depression remains an area of significant unmet medical need, as current therapies are ineffective and result in numerous side effects. We look forward to completion of our ongoing proof-of-concept clinical trial which could provide a new approach to the treatment of bipolar depression."
Repligen is currently conducting a Phase 2b clinical trial of RG2417 designed to confirm and extend the positive results obtained in a Phase 2a clinical trial which demonstrated that RG2417 was well tolerated and resulted in a statistically significant improvement in the symptoms of bipolar depression over the six-week treatment period compared to placebo. The ongoing Phase 2b clinical trial is a 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 impact of RG2417 on the symptoms of bipolar depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) and the Clinical Global Impression of Change in Bipolar Depression Scale (CGI-BP-C). This study is being conducted at approximately 20 clinical sites within the United States.
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 and depression. 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 $600,000 per patient, depending on resistance to treatment and persistence of symptoms. Although several therapies are approved for the treatment of bipolar disorder, many individuals are unable to tolerate treatment-related side effects, and incomplete clinical response, relapse and recurrence remain common clinical problems.