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Repligen previously reported positive initial results from a Phase 2aclinical trial of RG2417 in patients with bipolar disorder. We have nowcompleted our assessment of the data and have found that patients with ahistory of more frequent symptoms demonstrated greater improvements whentreated with RG2417 than patients without a history of frequent symptoms. Forexample, patients with more than 5 episodes of depression over their entirelife (n=50) demonstrated greater improvements in their symptoms of depressioncompared to patients with 5 or fewer lifetime episodes of depression. Fromweeks 2-6 of treatment, the patients with more than 5 lifetime episodes ofdepression who received RG2417 had an average improvement on MADRS of 5.5points over placebo (p<0.001), compared to all patients in the study receivingRG2417 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 inaccurately diagnosing bipolar disorder in the absence of frequentsymptomatology and will be used in the design and execution of the next study.
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"The safety and efficacy results of our previous study of RG2417 stronglysupport further evaluation in patients with bipolar disorder," stated WalterC. Herlihy, President and Chief Executive Officer of Repligen Corporation."We are very pleased to have someone with Gary's expertise to lead the nextphase of our clinical development program."
The previously reported Phase 2a study was a multi-center study in which83 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 symptomsat baseline with the exception of mania for which the RG2417 group mania scorewas significantly higher (p=0.01). The objective of the study was to assessthe safety and efficacy of RG2417 on the symptoms of bipolar depression asmeasured by the co-primary endpoints, the Montgomery-Asberg Depression RatingScale (MADRS) and the Clinical Global Impression of Change in Bipolar Disorderscale (CGI-BP-C). Patients were evaluated at baseline and then weekly usingthese standardized tools to assess change in their symptoms. Over thesix-week treatment period, the study demonstrated a statistically significantimprovement in the symptoms of depression in the patients receiving RG2417when 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 StanleyMedical Research Institute, the largest nonprofit provider of funding forresearch on schizophrenia and bipolar disorder in the United States.
About Bipolar Disorder
Bipolar disorder, also known as manic depression is an illness marked byextreme changes in mood, thought, energy and behavior in which a person's moodcan alternate between the "poles" of mania and depression. Bipolar disorderaffects more than two million adults
