Reports Full Assessment of Data from Positive Phase 2a Trial
WALTHAM, Mass., June 12 /PRNewswire-FirstCall/ -- Repligen Corporation (Nasdaq: RGEN) today announced that based on feedback from the Food and Drug Administration, the Company plans to initiate a Phase 2b clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar disorder later this year. This will be a multi-center, parallel arm placebo-controlled, clinical trial in which approximately 150 patients with bipolar disorder will receive either RG2417 or a placebo twice a day for eight-weeks. This study is designed to assess the efficacy and safety of RG2417 on the symptom of depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). Gary S. Sachs, M.D., founder and director of the Bipolar Clinic and Research Program at the Massachusetts General Hospital and an Associate Professor of Psychiatry at the Harvard Medical School will be the Principal Investigator of this study.
Repligen previously reported positive initial results from a Phase 2a clinical trial of RG2417 in patients with bipolar disorder. We have now completed our assessment of the data and have found that patients with a history of more frequent symptoms demonstrated greater improvements when treated with RG2417 than patients without a history of frequent symptoms. For example, patients with more than 5 episodes of depression over their entire life (n=50) demonstrated greater improvements in their symptoms of depression compared to patients with 5 or fewer lifetime episodes of depression. From weeks 2-6 of treatment, the patients with more than 5 lifetime episodes of depression who received RG2417 had an average improvement on MADRS of 5.5 points over placebo (p<0.001), compared to all patients in the study receiving RG2417 who had an average improvement on MADRS of 3.0 points over placebo (p=0.01) as previously reported. This result may reflect the difficulty in accurately diagnosing bipolar disorder in the absence of frequent symptomatology and will be used in the design and execution of the next study.
"The safety and efficacy results of our previous study of RG2417 strongly support further evaluation in patients with bipolar disorder," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. "We are very pleased to have someone with Gary's expertise to lead the next phase of our clinical development program."
The previously reported Phase 2a study was a multi-center study in which 83 patients received either RG2417 or a placebo twice a day for six-weeks. Patients in the RG2417 and placebo groups were well matched in their symptoms at baseline with the exception of mania for which the RG2417 group mania score was significantly higher (p=0.01). The objective of the study was to assess the safety and efficacy of RG2417 on the symptoms of bipolar depression as measured by the co-primary endpoints, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Clinical Global Impression of Change in Bipolar Disorder scale (CGI-BP-C). Patients were evaluated at baseline and then weekly using these standardized tools to assess change in their symptoms. Over the six-week treatment period, the study demonstrated a statistically significant improvement in the symptoms of depression in the patients receiving RG2417 when compared to placebo on the MADRS (p=0.01) and on the CGI-BP-C (p=0.044).
A complete review of the data suggests that RG2417 was well tolerated. This study was conducted under a development agreement with the Stanley Medical Research Institute, the largest nonprofit provider of funding for research on schizophrenia and bipolar disorder in the United States.
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 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 $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.
About The Stanley Medical Research Institute
The Stanley Medical Research Institute (SMRI) is a nonprofit organization that supports research on the causes and treatment of schizophrenia and bipolar disorder (manic-depressive illness), both through work carried out in its own laboratories and through support of researchers worldwide who are working on these diseases. SMRI is the largest nonprofit provider of research funding for schizophrenia and bipolar disorder in the United States and has provided over $200 million in funding since 1989.
About Repligen Corporation
Repligen Corporation is a biopharmaceutical company focused on the development of novel therapeutics for diseases that affect the central nervous system. In addition, we are the world's leading supplier of recombinant Protein A, the sales of which partially fund the advancement of our development pipeline while supporting our financial stability. Repligen's corporate headquarters are located at 41 Seyon Street, Building #1, Suite 100, Waltham, MA 02453. Additional information may be requested from http://www.repligen.com.
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