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Repligen bipolar drug fails in study

An oral form of uridine being developed by Repligen as a potential treatment for bipolar depression failed to show efficacy in a late-stage clinical trial

An oral form of uridine being developed by Repligen as a potential treatment for bipolar depression failed to show efficacy in a late-stage clinical trial.

The drug, currently known as RG2417, did not deliver any improvement in the symptoms of depression compared to placebo during the eight-week phase IIb study in the 125 subjects who were enrolled at commercial clinical trial sites.

However, Repligen noted that a preliminary analysis indicates that in the 50 patients in the study enrolled through academic medical centres, the active drug showed a clinically meaningful improvement on the Montgomery-Asberg Depression Rating Scale (MADRS) compared to placebo from weeks two through eight.

The study also showed that RG2417 was safe and well-tolerated.

"While we are disappointed with the top-line results of the study, we plan to conduct further evaluation of the data, including the observation of differences between the patients treated in academic and commercial sites, to determine if there is a path forward with RG2417," Repligen president and CEO Walter C Herlihy said in a statement.

However, the CEO added that in the short term, Repligen plans to focus on completing a phase III trial for its pancreatic imaging agent RG1068, with results expected to be announced next month. The product is a synthetic human secretin intended to improve visualisation of the ducts of the pancreas when used in combination with magnetic resonance imaging to help in the diagnosis and treatment of pancreatitis.

Herlihy said the company will also concentrate on advancing its lead compounds for Friedreich's ataxia and for spinal muscular atrophy into the clinic "while maintaining a low cash burn and a strong balance sheet."

The phase IIb trial compared RG2417 to placebo administered twice a day for eight weeks. Evaluations for symptoms of depression were conducted at baseline and then weekly using the MADRS, as well as weekly self-assessments conducted by the patients.

The trial had been intended to confirm and extend the positive results of a phase IIa clinical trial in which 83 patients with bipolar disorder received either RG2417 or placebo twice daily for six weeks. That trial showed a statistically significant reduction in the symptoms of depression in patients receiving RG2417 compared to placebo.

8th March 2011

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