Nefecon is an oral small molecule product which downregulates the inflammatory process in the kidneys.
Nefecon is being co-developed by Pharmalink and Archimedes Pharma under a partnership agreed in January 2004 to bring the product candidate to proof-of-concept.
Nefecon 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.
Pharmalink previously announced global patent coverage and results from a planned interim analysis of an ongoing open Phase II trial which was designed to evaluate the efficacy and safety of Nefecon in IgA nephropathy, a glomerulonephritis leading to end-stage renal disease.
Pharmalink MD Johan Haggblad said that the orphan drug designation granted by the FDA is very encouraging for their team as they now look to start executing on activities leading up to registration trials.