Repligen Reports Positive Phase 2a Clinical Trial Results of RG2417 for Symptoms of Bipola...( WALTHAM Mass. Nov. 8 /- Repligen ...),Health

WALTHAM, Mass., Nov. 8 /PRNewswire-FirstCall/ -- Repligen Corporation (Nasdaq: RGEN) today announced positive results from a Phase 2a clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar disorder. This was a multi-center study in which 84 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=0.03) and a strong trend toward improvement on the CGI-BP-C (p=0.06).

Secondary observations from the study included a statistically significant decrease in mania score as determined using the Young Mania Rating Scale (YMRS) for mania (p=0.01), in the patients receiving RG2417 over the aggregate six-week treatment period when compared to placebo. Preliminary 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 an
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