Pharmalink has completed recruitment of patients into a Phase IIb NEFIGAN study of its orphan drug product, Nefecon. Pharmalink expects to announce top-line results in mid-2015.
The Phase IIb study is a multi-center, randomized, double-blinded placebo-controlled clinical trial designed to assess the efficacy and safety of two different doses of Nefecon in 90 IgA nephropathy patients at risk of end-stage renal failure, despite optimized standard-of-care therapy. The study is being conducted in 62 renal centers in ten European countries.
The primary efficacy objective of the study is to investigate whether patients on Nefecon achieve a larger mean reduction in proteinuria compared to patients on placebo.
Randomized patients are treated for nine months following a six-month run-in phase in which standard-of-care therapy is optimized. The study will enable an optimal dose of Nefecon to be selected for a Phase III registration trial.
Alex Mercer, Clinical Development Director of Pharmalink, said: “The response to this study from renal disease specialists across Europe has been outstanding and to complete recruitment within one year in this rare disease is a sign of the great interest the study has generated. This enthusiasm bodes well for the future as we advance Nefecon towards marketing approval. If the highly promising results we have seen in earlier studies are confirmed in NEFIGAN, we trust that Nefecon can become an effective new treatment for IgA nephropathy patients at risk of renal failure.”
Bengt Fellström, MD, PhD, Professor of Medicine at Uppsala University Hospital, Sweden and Principal Investigator of the NEFIGAN study, added: “IgA nephropathy is a disease with a high unmet medical need. Progression to renal failure has a terrible impact on patients’ quality of life and is a high burden to health care systems. A new medicine for early treatment with the potential to stop disease progression and minimize any further loss of renal function would be very welcome news to patients and clinicians alike. I am delighted at the response we have had from the renal disease community to this study, which has led to its rapid recruitment, and now look forward to the results in due course.”