Thursday, November 6, 2008

Repligen moves bipolar depression drug to Phase 2b trials

By Mass High Tech Staff

Waltham biopharmaceutical firm Repligen Corp. has begun a Phase 2b clinical trial of its bipolar depression treatment, RG2417, company officials reported.

The eight-week Phase 2b clinical trial consists of 150 patients diagnosed with bipolar depression receiving either RG2417 or a placebo twice daily for the trial term. The trial is intended to determine the safety of the drug. Conducted at 20 locations, the trial will measure results based on the Montgomery-Asberg Depression Rating Scale and the Clinical Global Impression of Change in Bipolar Disorder Scale.

The drug, an oral form of uridine, showed positive results in the Phase 2a clinical trial that successfully lowered symptoms of depression in patients taking RG2417. The Phase 2a trial consisted of a six-week, 83-patient test that supported patient safety associated with the drug.

In September, Repligen (Nasdaq: RGEN) announced that it had received $1.125 million in research grants to develop tools to help create new treatments for the rare neurodegenerative disease Friedreich’s ataxia. The Muscular Dystrophy Association awarded Repligen $1 million and the Friedreich’s Ataxia Research Foundation and the National Ataxia Foundation combined to give $125,000, according to Repligen officials. The company said it planned to use the funds to develop and prepare drug candidates for clinical trials and also develop biomarkers to monitor the effect of the drugs.

For the second quarter in 2008, Repligen reported a net gain of $8.3 million on total revenue for the quarter of $13.7 million.