Pharmalink AB, a specialty pharma company focused on orphan and niche products, announces that clinical results from the initial run-in phase of its Phase IIb clinical study with Nefecon® will be presented in a poster during Kidney Week 2014, the annual meeting of the American Society of Nephrology (ASN). The abstract of the presentation is published on the ASN website (click here), and details are below. ASN Kidney Week, the world’s largest nephrology meeting, will take place 11- 16 November in Philadelphia, PA.
Nefecon is a new oral modified-release capsule formulation of the corticosteroid, budesonide, in 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, placebo-controlled study (NEFIGAN Trial). Patients entering the study undertake a six-month Run-in Phase during which standard-of-care therapy [angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin II receptor I blocker (ARB)] is optimized according to KDIGO guidelines*. Run-in phase data from patients completing the Run-in Phase will be presented.
Alex Mercer, Clinical Development Director of Pharmalink, said:
“The data from the Run-in Phase of the NEFIGAN Trial show that IgAN patients remain at risk of progression to ESRD despite optimized standard-of-care therapy, and highlight the need for new treatment options. This need is recognized in the renal disease community and we have been delighted with the positive and enthusiastic engagement from key opinion leaders in the area around the NEFIGAN Trial. This support has enabled Pharmalink to complete enrolment into the study and remain on track to report headline results in Q3 2015 as planned.”
Poster title: The NEFIGAN Trial: A Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NEFECON® in IgA Nephropathy Patients at Risk of Developing ESRD: Preliminary data from the Run-in Phase
Poster board #: TH-PO442
Session Title: Glomerular and Tubulointerstitial Disease: Clinical Trials and Outcomes
Session Date, Time: Thursday, 11/13/2014, 10:00 AM – 12:00 PM
*KDIGO – Kidney Disease Improving Global Outcomes kdigo.org/