BioCentury
ARTICLE | Clinical News

sterna's SB012 meets in Phase IIa data for UC

March 2, 2018 1:09 AM UTC

sterna biologicals GmbH & Co. KG (Marburg, Germany) said intrarectal SB012 met the primary endpoint of improving disease activity from baseline to day 28 as measured by total Mayo Score vs. placebo in the Phase IIa SECURE trial to treat moderate to severe ulcerative colitis (UC). SB012 reduced total Mayo Score from baseline to day 28 by 1.9 points vs. 1 point for placebo (p=0.044). At day 56, SB012 reduced total Mayo Score from baseline by 3.4 points (p=0.016 compared to baseline). SB012 was well tolerated. Data were presented at the European Crohn's and Colitis Organisation meeting in Vienna.

The double-blind, German trial enrolled 20 patients to receive placebo or once-daily SB012 for 28 days. Secondary endpoints include total Mayo Score at day 56, endoscopic Mayo score, pharmacokinetics and safety...