Repligen Corporation has reported results from a Phase IIb clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar depression.
The study did not show a statistically significant improvement in the symptoms of depression in patients treated with RG2417 when compared to placebo over the eight-week treatment period.
RG2417 was well tolerated, without any serious adverse events related to drug treatment.
A preliminary analysis revealed that the subset of 50 patients enrolled through academic medical centres showed a clinically meaningful improvement on the Montgomery-Asberg Depression Rating Scale score from weeks two through eight when compared to placebo.
Similar results were observed with several of the secondary endpoints.
The double-blind, placebo-controlled trial enrolled 175 patients at 12 academic and 17 commercial study sites.
The patients were randomised in a 1:1 ratio to receive either RG2417 or a placebo twice a day for eight weeks.
Repligen Corporation president and chief executive officer Walter Herlihy said the company plans 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.
