InDex Pharmaceuticals Publishes Post-hoc Analysis of the COLLECT Study
InDex Pharmaceuticals Publishes Post-hoc Analysis of the COLLECT Study |
[19-October-2018] |
STOCKHOLM, October 19, 2018 /PRNewswire/ -- InDex Pharmaceuticals Holding AB (publ) today announced the publication of a post-hoc analysis of COLLECT study data. COLLECT was a clinical study of the Toll-like receptor 9 (TLR9) agonist cobitolimod, a first-in-class treatment for patients with moderate to severe ulcerative colitis (UC). The paper, published in the October issue of the peer-reviewed journal Digestive and Liver Disease (DLD), presents the clinical effect of cobitolimod on patient-reported outcomes (PRO) defined endpoints and in different patient subgroups defined by disease activity or anti-TNFα therapy exposure. In the COLLECT study, 131 patients with moderate to severe active UC and an inadequate response to conventional therapy received either cobitolimod or placebo, in addition to standard of care therapies. The study was conducted at 38 sites in seven European countries. The main results including primary and secondary endpoints were previously published in the Journal of Crohn's and Colitis in November 2016. 104 patients with available e-diary data were included in a post-hoc analysis, out of which 70 had been treated with cobitolimod and 34 with placebo. Symptomatic remission, defined as absence of blood in stool and a mean daily stool frequency <4, based on e-diary records was achieved at week 4 in 17.1% of cobitolimod vs. 5.9% of placebo treated patients (p=0.13), at week 8 in 35.7% of cobitolimod vs. 17.6% of placebo treated patients (p=0.07), and at week 12 in 38.6% of cobitolimod vs. 17.6% of placebo treated patients (p=0.04). As expected, symptomatic remission rates in the cobitolimod and placebo group were smaller for anti-TNFα experienced patients, but with a similar relative effect-size compared to anti-TNFα naïve patients. In addition, clinical efficacy was in general higher in patients with moderate compared to severe disease, which is in line with what has been reported for other therapies in this indication. The data have previously been presented at the United European Gastroenterology Week (UEGW), the Digestive Disease Week (DDW) and the annual congress of the European Crohn's and Colitis Organisation (ECCO). "The post-hoc analysis shows that cobitolimod is able to induce symptomatic remission in clinically relevant subgroups of UC patients," said Peter Zerhouni, CEO of InDex Pharmaceuticals. "We are pleased that our results continue to meet considerable interest from the scientific community as we continue the work of taking cobitolimod through the ongoing phase IIb dose optimisation study CONDUCT." The publication has the title "Clinical efficacy of the Toll-like receptor 9 agonist cobitolimod using patient-reported-outcomes defined clinical endpoints in patients with ulcerative colitis", and the publication can be found at www.dldjournalonline.com, Atreya R et al. Dig Liver Dis. 2018 Oct;50(10): 1019-1029. Contact InDex Pharmaceuticals: Cobitolimod in brief InDex Pharmaceuticals in brief InDex is based in Stockholm, Sweden. The company's shares are traded on Nasdaq First North Stockholm. Redeye AB is the company's Certified Adviser. For more information, please visit www.indexpharma.com This information was brought to you by Cision http://news.cision.com The following files are available for download:
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Company Codes: ISIN:SE0008966295, NASDAQ-MF:INDEX |
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