Pharmalink AB announced today that it has completed its open Phase II trial evaluating the efficacy and safety of Nefecon® in IgA nephropathy, a glomerulonephritis leading to end-stage renal disease. Nefecon is an enteric formulation of a locally acting corticosteroid which downregulates the inflammatory process in the kidneys through suppression of the gut immune system.
Sixteen patients at trial centers in Sweden were treated for six months followed by a three month follow up period. Full results will be presented at the World Congress of Nephrology 2009, 22-26 May in Milan (Smerud et al, Enteric Budesonide Ameliorates Albuminuria and Glomerular Filtration Rate in IgA Nephropathy Patients) and at the satellite meeting, IgA Nephropathy, 26-28 May in Stresa, Italy.
“It is very gratifying to have completed this important stage in the development of Nefecon,”
said Johan Häggblad, Managing Director of Pharmalink.
“We hope to bring a new licensed treatment where other therapies have failed and will now focus on preparing for pivotal trials and on seeking a development partner to bring Nefecon through Phase III and to the market.”
Nefecon is being co-developed by Pharmalink and Archimedes Development Ltd (“Archimedes”) a subsidiary of Archimedes Pharma Ltd under a partnership agreed in January 2004 to bring the product candidate to proof-of-concept. The concept underlying the renal disease product candidate Nefecon is a patented invention by Professors Bengt Fellström and Roger Hällgren at Uppsala University, Sweden. It is delivered using Archimedes’ proprietary TARGIT® drug delivery technology which enables the localized delivery of drugs to the lower small intestine or colonic regions of the gut. Archimedes is providing access to the TARGIT platform and providing all trial supplies of Nefecon. Pharmalink is responsible for the management of the clinical trials.