The NEFIGAN Trial of Pharmalink AB’s Nefecon®, a drug for the treatment of primary IgA nephropathy, was stopped early because the drug fully met its primary efficacy endpoint at a planned interim analysis, according to news from BioSpace.com.
The interim analysis, conducted by the Data & Safety Monitoring Board (DSMB), showed that Nefecon treatment, with both both treatment groups combined, resulted in a highly-significant improvement in the mean reduction in the urine protein/creatinine ratio (UPCR) during the nine-month treatment period, as compared to a placebo. These results will help determine an optimal dose of Nefecon for a Phase 3 registration trial.
The NEFIGAN Trial is a Phase 2b randomized double-blinded, placebo-controlled clinical trial assessing the safety and efficacy of two different doses of Nefecon. The trial was conducted in 62 centers in 10 European countries and originally was intended to recruit 90 patients. Over-recruitment increased this to more than 150 patients.
“Meeting the primary endpoint of the NEFIGAN Trial with such high significance and at this interim analysis is a tremendous result and major milestone for Pharmalink,” says Johan Häggblad, Ph.D., managing director of Pharmalink, said in a BioSpace.com report. “The NEFIGAN Trial was conducted with excellent efficiency, and the fact that the patient recruitment target was also exceeded so rapidly indicates the clear unmet medical need for new treatments for IgA nephropathy patients.”
“IgA nephropathy is the most common inflammatory renal disease and in real need of new treatment options,” adds Bengt Fellström, MD, PhD, professor of nephrology at Uppsala University Hospital, Sweden, and principal nvestigator of the NEFIGAN Trial. “Existing options are insufficient to prevent a significant proportion of patients from progressing to renal failure, with a devastating impact on patients’ quality of life. No current therapies address the root cause of the disease, which makes the results from the NEFIGAN Trial all the more encouraging.”
Enrolled patients will conclude the treatment phase by the end of April and complete the three-month follow-up phase of the study, according to BioSpace. Results are expected in the third quarter of 2015.