WALTHAM, Mass., Nov. 6 /PRNewswire-FirstCall/ -- Repligen Corporation (Nasdaq: RGEN) announced today 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-center, 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, 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.
"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 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 alternates between the "poles" of mania (highs) and depression (lows). 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 average lifetime financial burden of bipolar disorder in the United States is about $625,000 per patient. 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, lack of compliance in taking medication, and relapse remain common clinical problems.
About Repligen Corporation
Repligen Corporation is a biopharmaceutical company focused on the development of novel therapeutics for neurological disorders. 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.
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements in this release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, statements regarding current or future financial performance and position, management's strategy, plans and objectives for future operations, plans and objectives for product development, plans and objectives for present and future clinical trials and results of such trials, plans and objectives for regulatory approval, litigation, intellectual property, product development, manufacturing plans and performance such as the anticipated growth in the monoclonal antibody market and our other target markets and projected growth in product sales, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: the success of current and future collaborative relationships, the market acceptance of our products, our ability to compete with larger, better financed pharmaceutical and biotechnology companies, new approaches to the treatment of our targeted diseases, our expectation of incurring continued losses, our uncertainty of product revenues and profits, our ability to generate future revenues, our ability to raise additional capital to continue our drug development programs, the success of our clinical trials, our ability to develop and commercialize products, our ability to obtain required regulatory approvals, our compliance with all Food and Drug Administration regulations, our ability to obtain, maintain and protect intellectual property rights for our products, the risk of litigation regarding our intellectual property rights, our limited sales and manufacturing capabilities, our dependence on third-party manufacturers and value added resellers, our ability to hire and retain skilled personnel, our volatile stock price, and other risks detailed in Repligen's filings with the Securities and Exchange Commission. Repligen assumes no obligation to update any forward-looking information contained in this press release or with respect to the announcements described herein.
|SOURCE Repligen Corporation|
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