Repligen Corporation announced that the company has initiated a phase-2b clinical trial to evaluate the use of RG2417, an oral formulation of uridine, in patients with bipolar depression. This phase-2b study is a multi-centre, 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 (CGI-BP-C).

The study will be conducted at approximately 20 clinical sites within the United States. The Principal Investigator of this study is Gary S Sachs, founder and director of the Bipolar Clinic and Research Programme at the Massachusetts General Hospital and an Associate Professor of Psychiatry at the Harvard Medical School.

"Episodes of depression are the most frequent and long-lived symptom of bipolar disorder and account for the majority of the disease impairment. 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," said Walter C Herlihy, president and chief executive officer of Repligen. "We look forward to confirming our prior results with RG2417 in bipolar depression in this larger proof-of-concept clinical trial."

The trial is designed to confirm and extend the results obtained in a positive phase-2a clinical trial of RG2417 in which 83 patients with bipolar disorder received either RG2417 or placebo twice daily for six weeks. The phase-2a 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. The data also demonstrated that RG2417 was safe and well tolerated. This study was partially supported by the Stanley Medical Research Institute, the largest non profit provider of funding for research on schizophrenia and bipolar disorder in 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 alternates between the 'poles' of mania (highs) and depression (lows).

Repligen Corporation is a biopharmaceutical company focused on the development of novel therapeutics for neurological disorders.