Sweden-based specialty pharmaceutical company Pharmalink 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. Approximately 16 patients at trial centers in Sweden were treated for six months followed by a three month follow up period.
According to Pharmalink, 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.
Nefecon is being co-developed by Pharmalink and Archimedes Development, a subsidiary of Archimedes Pharma under a partnership agreed in January 2004 to bring the product candidate to proof-of-concept.
Nefecon is delivered using Archimedes’s 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.
Johan Haggblad, managing director of Pharmalink, said: It is very gratifying to have completed this important stage in the development of Nefecon. 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.