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news.Pharmalink has enrolled first patient in the Phase IIb study designed to assess Nefecon in primary IgA nephropathy patients with the chance to develop an end-stage renal disease.
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The multi-centre, randomised study will evaluate the efficacy and safety of two different doses of Nefecon, an enteric formulation of a locally acting corticosteroid.
Primary objective of the trial is to analyze if patients administered with Nefecon demonstrate a larger mean reduction in proteinuria compared to placebo group patients.
Pharmalink clinical development director Alex Mercer said no approved treatments are available on the market today for IgA nephropathy, a disease with a high unmet medical need.
"Pharmalink hopes to bring a new medicine to patients for early treatment, halting disease progression and further loss of renal function," Mercer added.
"We look forward to confirming the highly promising results we have seen so far with Nefecon and to advancing the product in this pivotal phase IIb trial."
Company expects to report the top line results from the double-blinded placebo controlled study in the first half of 2015.