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Equinox (APD334) is an oral, selective antimony alcohol 1-phosphate regulator used to treat immunomediated inflammatory diseases and is currently in the research and development stage.
this Phase 2, Double Blind, Parallel Group study aims to assess the efficacy and safety of equsimod in patients with moderate to severe active ulcerative colitis (UC), the results of which were published online in Gastroenterology.
from 15 October 2015 to 14 February 2018, researchers included improved Mayo Clinic Scores (MCSs) (stool frequency, rectal bleeding and endoscopy results) at 4-9 points, endoscopy scores≥ Adult outpatients with ≥2 points, rectal bleeding score ≥1 points) were randomly assigned to a daily group of 1mg of equmod (n s 52), ethimod 2mg (n s 50) or placebo (n s 54) for 12 weeks.
end point is to improve mcS from baseline to week 12.
secondary endpoint includes the proportion of patients who have improved the mirror (sub-score of 1 or less) from baseline to week 12.
results showed that in week 12, the Icsimod 2 mg group reached the primary and secondary endpoints.
Iqusimod 2 mg resulted in a significant increase in the average improvement of the improved MCS compared to the placebo (difference from placebo, 0.99 points; 90% confidence interval, 0.30-1.68; P - .0) 09), Iqusimod 1 mg increased the average improvement of the improved MCS by 0.43 points from the baseline compared to the placebo (90% confidence interval, from 0.24 to an increase of 1.11; P . . . 15).
41.8 percent of patients who received 2mg of ethmodes and 17.8 percent of patients who received a placebo improved endoscopic results (P . . . 003).
most adverse events were mild to moderate, and three patients had short, asymptomatic, low-level room blocking.
, the results showed that in patients with moderate to severe active ulcerative colitis, 2 mg of equsimod improved clinical and endoscopic results.
is yet to be further developed clinically.
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