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news.Sweden-based specialty pharma company Pharmalink has announced that its investigational new drug (IND) application for Nefecon is now open with the US Food and Drug Administration (FDA).
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Nefecon is a new oral modified-release capsule of the corticosteroid, budesonide, being developed to treat patients with IgA nephropathy (IgAN) at risk of developing end-stage renal disease (ESRD), despite optimized RAS blockade.
The company is currently evaluating the safety and efficacy of Nefecon in a prospective, randomized, double-blinded, placebo-controlled Phase IIb trial in 150 patients and is being carried out at more than 60 centers in ten European countries.
According to the company, headline results of the Nefigan Trial are expected to be reported during the third quarter of 2015.
Pharmalink regulatory affairs director Heather Cook 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."
IgAN is the most common form of glomerulonephritis and is characterized by deposits, predominantly containing polymeric IgA antibody, in the kidney that cause inflammation and renal damage.