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Equinox (APD334) is an oral, selective arginol 1-phosphate-subject regulator that is being developed for immunomediated inflammatory diseases.
This Phase 2, Proof of Concept, Double-Blind, Parallel Group study assessed 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.
study put the improved Mayo Clinic score (MCSs) (stool frequency, rectal bleeding and endoscopy results) at 4-9 points, endoscopy score at 2 or above, rectal bleeding score at 1 or More than one adult outpatient was randomly assigned to a daily group of 1 mg (n s 52), ethmod 2 mg (n s 50) or a placebo (n s 54) for 12 weeks.
the study was conducted at 87 centres in 17 countries from 15 October 2015 to 14 February 2018.
end point is an increase in the average improvement of the improved MCS from baseline to week 12.
secondary endpoint includes the proportion of patients with mirror improvement (sub-score of 1 or less) from baseline to week 12.
the study was statistically able to draw conclusions about the main endpoints, the paper reported exploratory endpoints, including clinical remission.
results showed that in week 12, the Iccimod 2 mg group reached the main and all secondary end points.
compared to placebos, Equsimod 2 mg significantly increased the average improvement of improved MCS from the baseline (difference from placebo, 0.99 points; 90% confidence interval, 0.30-1.68; P . 009), Equsimod 1 mg increased the average improvement of the improved MCS by 0.43 points more than the baseline (90% confidence interval, 0.24 to 1.11 increase; labeled P . . . 15).
41.8 percent of patients who received 2mg of ethmode and 17.8 percent of patients who received a placebo had endoscopic improvements (P . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
most adverse events are mild to moderate.
three patients developed short, asymptomatic, low-level room blocking and spontaneous remission, all of which showed evidence of room blocking before Equmod was exposed.
, the results showed that in patients with moderate to severe active ulcerative colitis, equsimod 2 mg improved clinical and endoscopic results more effectively than placebo.
to be further clinically developed.
.