Starch-wrapped steroid for kidney disease begins Phase IIb

Pharmalink's Nefecon (PL-56), a steroid drug packaged in an oral starch-based delivery system, has started a Phase IIb trial in patients with the kidney disease primary IgA nephropathy who run the risk of developing kidney failure.

Based on Archimedes Pharma's Targit drug delivery technology, Nefecon delivers the corticosteroid budesonide to the small intestine and colon, where it suppresses the immune system in the gut and reduces the inflammation behind the kidney damage. The Phase IIb study will involve about 50 centers across 10 European countries, and early results are expected in the first half of 2015.

Nefecon is in development to treat the 40% of patients with IgA nephropathy who have the most aggressive form of the disease and are at the greatest risk of end stage renal disease (ESRD), which has a major impact on quality of life and is expensive to treat. IgA nephropathy is an orphan disease and there are currently no approved drugs for it.

In a Phase IIa trial of Nefecon, the drug significantly reduced levels of proteinuria and serum creatinine, and increased glomerular filtration rates.

Pharmalink focuses on drug repurposing and reformulation to reduce risk and cut costs in drug development, as well as get drugs to the market more quickly.

- read the press release