Pharmalink AB (www.pharmalink.se), a specialty pharma company focused on orphan and niche products, announces that its IND for Nefecon is now open with the US Food & Drug Administration (FDA).
Nefecon is a new oral modified-release capsule of the corticosteroid, budesonide, in clinical development by Pharmalink for the treatment of patients with IgA nephropathy (IgAN) at risk of developing end-stage renal disease (ESRD), despite optimized RAS blockade.
The safety and efficacy of Nefecon is currently under evaluation in a prospective, randomized, double-blinded, placebo-controlled Phase 2b study (NEFIGAN Trial, www.nefigan.net) in 150 patients being conducted at more than 60 centres in ten European countries. Headline results of the NEFIGAN Trial are expected during Q3 2015. Nefecon has Orphan Drug Designation.
Heather Cook, Regulatory Affairs Director of Pharmalink, said: “The opening of the IND for Nefecon in the US is an important step in the development of this potential new therapy for IgAN patients. Recent data presented at American Society of Nephrology’s Kidney Week last November confirmed that these patients remain at risk of progression to ESRD despite optimized RAS inhibition, highlighting the need for new treatment options. Should the NEFIGAN Trial produce positive results later this year, reinforcing our earlier Phase 2a study findings, then we are confident in the potential of Nefecon to become a valuable new treatment for IgAN patients.”