Positive Phase 2b ICONA Interim Results for icosabutate in NASH Patients

Icosabutate demonstrates potent anti-inflammatory, anti-fibrotic and antioxidant properties, and shows improvement in cardio-metabolic risk profile

  • Interim readout based on the first 90 patients treated for 16 weeks
  • Once-daily oral icosabutate showed dose-dependent, significant, and clinically meaningful improvements in all liver function chemistry, and inflammatory and fibrotic biomarkers with a remarkable reduction of over 50% in hsCRP
  • Lipid profile and glycemic control showed significant improvements
  • Blinded safety data show a benign safety profile reviewed regularly by the DSMB

January 08, 2021 03:00 AM Eastern Standard Time

AMSTERDAM–(BUSINESS WIRE)–NorthSea Therapeutics B.V., (‘NST’) a Dutch biotech company developing novel and innovative therapies for NASH (Non-alcoholic Steatohepatitis) and other metabolic, inflammatory, and fibrotic diseases based on its SEFA (Structurally Engineered Fatty Acid) technology, today announced a positive interim readout of its ICONA Phase 2b study.

The ICONA study (ICOsabutate in NASH) aims to randomise 264 patients to one of three different treatment groups: placebo, icosabutate 300 mg once daily, or icosabutate 600 mg once daily, with a treatment period of 52 weeks. The study’s primary endpoint is resolution of NASH without worsening of fibrosis, based on changes in liver biopsy parameters compared to baseline after 52 weeks.