Pharmalink AB announced today highly promising results from a planned interim analysis of an ongoing open Phase II trial which is designed to evaluate the efficacy and safety of Nefecon® in IgA nephropathy, a glomerulonephritis leading to end-stage renal disease. Nefecon® is an oral small molecule product which downregulates the inflammatory process in the kidneys. It is being co-developed by Pharmalink and Archimedes Pharma under a partnership agreed in January 2004 to bring the product candidate to proof-of-concept.
“We are encouraged to see that the ten patients evaluated so far show results consistent with efficacy of the drug,”
said Johan Häggblad, Managing Director of Pharmalink.
“These patients, who have failed in other therapies, completed a six month treatment course without disease progression.”
The interim study results, although not yet conclusive, suggest a stabilization of the disease with some cases progressing towards remission. Nefecon® is well tolerated with few or no side-effects. Endpoints studied were proteinuria, serum creatinine, glomerular filtration rate as well as parameters indicative of drug mechanism-related side effects. Patients were treated for six months followed by a three months follow up period.
The concept underlying the renal disease product candidate Nefecon® is a patented invention by Professors Bengt Fellström and Roger Hällgren at Uppsala University (Sweden). It is delivered using Archimedes Pharma’s proprietary TARGIT® drug delivery technology enabling the delivery of drugs to the ileocaecal region of the gut. Archimedes is providing access to the TARGIT® platform and providing all trial supplies of Nefecon®. Pharmalink is responsible for the management of the clinical trials.
“It is gratifying to see that the Nefecon concept is working as intended, delivering the active ingredient in a topical fashion to the ileocaecal region of the gut and stabilizing the disease,” said inventor Professor Bengt Fellström.
“We are looking forward to completing this trial and moving on to Phase III studies.”
On behalf of the partnership, Pharmalink is actively seeking a development partner to bring Nefecon® through Phase III and to the market.