Roche Holding AG (USOTC:RHHBY) said Wednesday that sefaxersen met the primary endpoint in a Phase III trial evaluating the treatment in patients with IgA nephropathy.
The IMAGINATION study showed a statistically significant reduction in proteinuria compared with placebo at 37 weeks, according to the Swiss pharmaceutical company.
Proteinuria, or excess protein in the urine, is a marker used in assessing IgA nephropathy, a disease affecting the kidneys.
Roche Cites Potential of Sefaxersen
Roche said the results indicated what it described as “best-in-class potential” for sefaxersen in IgA nephropathy.
The company did not provide detailed efficacy figures in the information released Wednesday.
The safety and tolerability profile observed in the Phase III study was consistent with previously reported data, Roche said, with no new safety signals identified.
Results to Be Presented at Medical Meeting
Roche plans to present the interim IMAGINATION data at an upcoming medical meeting.
The company also intends to share the findings with health authorities as it considers the next steps for the treatment.
Roche did not provide a timetable for potential regulatory submissions.