STOCKHOLM, May 31, 2017 /PRNewswire/ --
Pharmalink AB, a specialty pharma company, is pleased to announce that its recent publication in The Lancet on the positive Phase 2b trial of Nefecon® in primary IgA nephropathy (IgAN) patients, has been selected for presentation at the upcoming European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) conference (Madrid, Spain; June 3-6, 2017).
The Phase 2b trial (known as the NEFIGAN trial), will be presented in a special session co-hosted by The Lancet by lead author Bengt Fellström, MD, PhD, Professor of Nephrology at Uppsala University Hospital and Principal Investigator of the NEFIGAN Trial.
Title: Effects of a novel targeted release formulation of budesonide vs. placebo in IgA nephropathy: The NEFIGAN randomised clinical trial.
Session: The Lancet/ERA-EDTA Symposium
Date: Sunday, June 4, 2017
Time: 15:15-16:45 CET
Location: Hall 10.A
Prof. Fellström will give a second presentation of results from the NEFIGAN trial at the conference.
Title:Proteinuria reduction in IgA nephropathy by Nefecon, a targeted release formulation of budesonide - results from the NEFIGAN trial
Date: Tuesday, June 6, 2017
Time: 8.00-9.30 CET
Location: Sala Neptuno
About Pharmalink AB
Pharmalink is a specialty pharmaceutical company developing high value products for patients with significant unmet medical needs. With a highly experienced, dynamic management team, Pharmalink draws on its extensive experience of pharmaceutical development and marketing to efficiently identify and progress valuable and de-risked products. Visit http://www.pharmalink.se for further information.
Nefecon® is an investigational treatment for patients with primary IgA nephropathy (primary IgAN) at risk of developing ESRD. Nefecon® has successfully completed a randomized, placebo-controlled Phase 2b study in 149 primary IgAN patients (full analysis set) at risk of developing ESRD, under standardized rigorous blood pressure control with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin II receptor blocker (ARB). A Phase 3 registration trial is being planned.
Nefecon® is an oral, targeted-release and locally acting formulation of the potent corticosteroid, budesonide, that down-regulates the disease process in the kidney through suppression of the gastrointestinal immune system thus exploiting the pivotal role the gastrointestinal tract plays in the overall immune response. Promising results indicate that treatment with Nefecon® may provide clinical benefits to primary IgAN patients at risk of progressing to ESRD, and provide an alternative to dialysis and transplantation. Nefecon® has received orphan drug designation in primary IgAN by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
About the NEFIGAN trial
The NEFIGAN trial was randomized, double-blinded, and placebo-controlled in male and female patients (aged ≥18 years) with primary IgAN and overt proteinuria considered at risk of progressing to end-stage renal disease (ESRD). The trial was conducted at 62 sites across 10 European countries between November 2012 and June 2015. Data from 149 patients constituted the final analysis set, from a total of 249 patients screened.
About IgA Nephropathy
IgA nephropathy (IgAN) is the most common form of glomerulonephritis (inflammation of the kidney glomeruli). The disease is characterized by deposits, predominantly containing polymeric IgA antibody, in the kidney that cause inflammation and renal damage.
IgAN can occur at any age, but the clinical onset is commonly during the second or third decades of life. It has been estimated that up to 40% of patients with primary IgAN progress to renal failure, often referred to as ESRD within 5-30 years following diagnosis. This patient population is estimated to at least 200,000 in major markets.
Patients suffering renal failure require dialysis or kidney transplantation. Primary IgAN accounts for 10% of renal transplants among patients with primary glomerulonephritis in the US and between 7-20% of patients in Europe and Australia in long-term dialysis and renal transplantation programs.