Sweden-based Pharmalink has commenced its Nefecon Phase IIb study in patients with primary IgA nephropathy with the possibility of developing end-stage renal disease.
Nefecon, an enteric formulation of a locally acting corticosteroid, is designed to down-regulate the inflammatory process in the kidneys by inhibiting the gastrointestinal immune system.
Pharmalink clinical development director Alex Mercer said no approved treatments are available on the market today for IgA nephropathy, 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," Mercer said.
"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."
The multi-centre, randomised study is designed to assess the efficacy and safety of two different doses of Nefecon in 90 primary IgA nephropathy patients with the risk of developing an end-stage renal disease.
Double-blinded placebo controlled study’s primary objective is to assess if patients on Nefecon have a larger mean reduction in proteinuria compared to patients on placebo.
The company expects the top line results from the study in the first half of 2015.
Nefecon demonstrated positive safety and efficacy profile and was well tolerated in the open-labelled Phase IIa trial involving 16 patients at trial centres in Sweden.