Repligen starts phase 2 clinical trial of RG2417 for bipolar depression

By Elaine Rigoli

Tampa, Fla., March 9 - Repligen Corp. announced Thursday that the company has started a phase 2 clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar depression.

This phase 2 study is a multi-center, dose-escalating study in which 80 patients will receive either RG2417 or a placebo for six weeks, according to a company news release.

This study is being conducted under a development agreement with the Stanley Medical Research Institute, under which Repligen will receive about $1 million in funding.

The Stanley Medical Research Institute is the largest nonprofit provider of funding for research on schizophrenia and bipolar disorder in the United States, according to the release.

"Bipolar depression is a serious chronic illness and treatment is challenging due to the potential for induction of mania, a common side effect of standard treatment with antidepressants," Walter C. Herlihy, president and chief executive officer, said in a statement.

"If this proof of principle study shows evidence that RG2417 improves the symptoms of bipolar depression without inducing mania, it has the potential to be an important new therapy in an area of significant unmet medical need."

Repligen previously completed a six-week phase 1 clinical trial of a prodrug of uridine (RG2133) in patients with bipolar disorder or major depression, the release said.

The results demonstrated that administration of RG2133 in this patient population appeared to be safe, did not induce mania and provided early evidence of a clinical effect of the drug. The trial evaluated 19 patients and was carried out by investigators at McLean Hospital, the largest psychiatric clinical care, teaching and research affiliate of Harvard Medical School.

Repligen is a biopharmaceutical company with corporate headquarters in Waltham, Mass.

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