Date: 2014-01-13
Type of information: Completion of patient enrollment
phase: 2b
Announcement: completion of patient recruitment
Company: Pharmalink (Sweden)
Product: Nefecon® (Nefigan - budesonide)
Action
mechanism: Nefecon® is an enteric formulation of a locally acting corticosteroid, budesonide, that down-regulates the inflammatory process in the kidneys through suppression of the gastrointestinal immune system.
Disease: primary IgA nephropathy
Therapeutic area: Renal diseases - Rare diseases - Kidney diseases
Country: 10 European countries (Belgium, Czech Republic, Denmark, Finland, Germany, Italy, the Netherlands, Spain, Sweden, UK)
Trial
details: The study is a multi-center, randomized, double-blinded placebo controlled study to evaluate the efficacy and safety of two different doses of Nefecon® in 90 primary IgA nephropathy patients at risk of end-stage renal disease. The study is being conducted in 62 renal centers in ten European countries. The primary efficacy objective of the study is to investigate whether patients on Nefecon® achieve a larger mean reduction in proteinuria compared to patients on placebo. Randomized patients are treated for nine months following a six-month run-in phase in which standard-of-care therapy is optimized. The study will enable an optimal dose of Nefeconto be selected for a Phase III registration trial.
Latest
news: Nefecon® showed positive results in an open-labelled Phase IIa trial evaluating safety and efficacy with 16 patients at trial centers in Sweden. The final results of the study demonstrated a significant and clinically meaningful effect in the primary endpoint: reduction in proteinuria. Significant results were also seen in secondary endpoints: reduction of serum creatinine and increase in glomerular filtration rates. Furthermore, Nefecon® was well tolerated with few or no-drug related side effects.* On January 13, 2014, Pharmalink AB, a specialty pharma company focused on orphan and niche products, has announced it has completed recruitment of patients into a Phase IIb NEFIGAN study of its orphan drug product, Nefecon®. Pharmalink expects to announce top-line results in mid-2015.
* On December 18, 2012, Pharmalink has initiated a Phase IIb study with Nefecon® (Nefigan) in patients with primary IgA nephropathy at risk of developing end-stage renal disease. The first patient was recently enrolled in the clinical trial. The primary objective will be to investigate whether patients on Nefecon® have a larger mean reduction in proteinuria compared to patients on placebo. Pharmalink expects to announce top line results in the first half of 2015.
Nefecon® is a patented invention by Professors Bengt Fellström and Roger Hällgren at Uppsala University (Sweden) and was acquired by Pharmalink in 2004. Nefecon® is delivered using the proprietary TARGIT® drug delivery technology which enables the localized delivery of drugs to the lower small intestine or colonic regions of the gastrointestinal tract
