Date: 2015-01-21
Type of information: Submission of a clinical trial application
phase: 1
Announcement: Submission of a clinical trial application
Company: Pharmalink (Sweden)
Product: Nefecon®
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: USA
Trial details:
Latest
news: * On January 21, 2015, Pharmalink AB, a specialty pharma company focused on orphan and niche products, announced that its IND for Nefecon® is now open with the FDA. Nefecon® is a new oral modified-release capsule of the corticosteroid, budesonide, in clinical 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, double-blinded, placebo-controlled Phase 2b study in 150 patients being conducted at more than 60 centers in ten European countries. Headline results of the NEFIGAN Trial are expected during Q3 2015 (http://www.nefigan.net/). Nefecon® has Orphan Drug Designation.
