InDex Pharmaceuticals admits last patient in Phase IIb Study CONDUCT evaluating cobitolimod for ulcerative colitis.
M2 PHARMA-June 26, 2019-InDex Pharmaceuticals admits last patient in Phase IIb Study CONDUCT evaluating cobitolimod for ulcerative colitis
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Pharmaceutical company InDex Pharmaceuticals Holding AB (publ) said on Tuesday that it has enrolled its last ulcerative colitis patient under the dose optimisation cobitolimod study CONDUCT.
With top line results expected to be available in 8-10 weeks, the CONDUCT study has enrolled a total of 213 patients at 91 clinics in 12 European countries and investigates three different dose strengths and two different dose frequencies of cobitolimod, added the company.
The company added the CONDUCT is a randomised, double blind, placebo-controlled phase IIb study that will investigate three different dose strengths of cobitolimod: 30 mg, 125 mg and 250 mg given twice, at baseline and at week three. Also, 125 mg given four times, at baseline and each week until week three.
In conjunction, the primary endpoint of the CONDUCT study is induction of clinical remission at week six defined by modified Mayo sub scores, with a rectal bleeding score of 0, a stool frequency score of 0 or 1 and an endoscopy score of 0 or 1. The patients will be followed for a total of ten weeks, disclosed the company.
According to the company, cobitolimod is a Toll-like receptor 9 (TLR9) agonist, which can provide an anti-inflammatory effect locally in the large intestine, which may induce mucosal healing and relief of the clinical symptoms in ulcerative colitis.
Ulcerative colitis is a chronic disease caused by inflammation of the large intestine and the symptoms are characterised by blood- and mucus-mixed diarrhea, frequent stools, abdominal pain, fever, weight loss and anemia.
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|Date:||Jun 26, 2019|
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