Pharmalink announces that positive results and analyses from the completed Phase 2b trial of its oral drug candidate Nefecon in primary IgA nephropathy (IgAN) patients have been published online in The Lancet.
This is the first time the full results from this trial have been published in this format. In the paper, clinical data are presented that demonstrate the clear potential of Nefecon, a novel, targeted-release formulation of the corticosteroid budesonide, as a new treatment for patients with primary IgAN (a progressive inflammatory kidney disease). More specifically, the trial (known as the NEFIGAN Trial) met its primary endpoint and concluded that the use of Nefecon, in addition to standardized rigorous blood pressure control (optimized RAS blockade), reduced proteinuria and stabilized estimated glomerular filtration rate (eGFR) in patients at risk of developing end-stage renal disease (ESRD). Both of these effects are indicative of a reduced risk of future progression to ESRD.
Pharmalink is preparing to start pivotal Phase 3 studies of Nefecon in this indication.
“We are delighted with the results from the NEFIGAN Trial that have been published in the prestigious Lancet journal. These results have encouraged us in our considerations and preparations for a pivotal Phase 3 registration trial of Nefecon in primary IgAN patients. We thank all the investigators and patients who contributed to this clinical trial and look forward to advancing our clinical development plans with this exciting drug candidate,” said Johan Häggblad, CEO of Pharmalink.