Pharmalink AB, a Swedish specialty pharma company, today announces it has initiated a Phase IIb study with Nefecon® (Nefigan) in patients with primary IgA nephropathy at risk of developing end-stage renal disease. Nefecon is an enteric formulation of a locally acting corticosteroid that down-regulates the inflammatory process in the kidneys through suppression of the gastrointestinal immune system.
The study is a multi-center, randomized, double-blinded placebo controlled study to evaluate the efficacy and safety of two different doses of Nefecon in 90 primary IgA nephropathy patients at risk of end-stage renal disease. The first patient was recently enrolled in the clinical trial, which will be conducted at approximately 50 participating centers across 10 European countries. The primary objective will be to investigate whether patients on Nefecon have a larger mean reduction in proteinuria compared to patients on placebo. Pharmalink expects to announce top line results in the first half of 2015.
Nefecon showed positive results in an open-labelled Phase IIa trial evaluating safety and efficacy with 16 patients at trial centers in Sweden. The final results of the study demonstrated a significant and clinically meaningful effect in the primary endpoint: reduction in proteinuria. Significant results were also seen in secondary endpoints: reduction of serum creatinine and increase in glomerular filtration rates. Furthermore, Nefecon was well tolerated with few or no-drug related side effects.
IgA nephropathy is an orphan condition and Nefecon is aimed at providing patients with IgA nephropathy a disease modifying medication.
Alex Mercer , Clinical Development Director at Pharmalink, said: "IgA nephropathy is a disease with a high unmet medical need and no approved treatments available on the market today. Progression to renal failure has a terrible impact on patients' quality of life and is a high burden to health care systems. Pharmalink hopes to bring a new medicine to patients for early treatment, halting disease progression and further loss of renal function. We look forward to confirming the highly promising results we have seen so far with Nefecon and to advancing the product in this pivotal phase IIb trial."