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  • 21 June 2017
    InDex Pharmaceuticals enrolls first patient in the phase IIb study CONDUCT with cobitolimod

    InDex Pharmaceuticals Holding AB (publ) today announced that the first patient has been enrolled in the clinical study CONDUCT – a phase IIb dose optimisation study with the drug candidate cobitolimod. Cobitolimod is a first in class immunotherapeutic, which is being developed for the treatment of moderate to severe active ulcerative colitis.

    The CONDUCT study will include 215 patients with left-sided moderate to severe active ulcerative colitis at 90 sites in 12 countries. It is a randomised, double blind, placebo-controlled study for evaluating cobitolimod’s efficacy and safety in inducing clinical remission compared to placebo. The dose optimisation study investigates three different dose strengths of cobitolimod and two different dose frequencies.

    “This is an important milestone for InDex and represents another step towards our mission of providing more effective and safer drugs for this unmet medical need. SEK 250 million was raised in our IPO in October 2016, primarily to finance the CONDUCT study, and we are delivering according to plan”, said Peter Zerhouni, CEO of InDex Pharmaceuticals.

    “The goal of CONDUCT, while maintaining cobitolimod’s excellent safety profile, is to show a substantially higher efficacy than in previous studies, and also in comparison with what has been reported both for drugs on the market and other compounds in late stage clinical development for moderate to severe active ulcerative colitis”, he concluded.

    The study is conducted in collaboration with the leading global biopharmaceutical services company PAREXEL. Study drug for the complete study has been manufactured at APL in Sweden. The objective is to have top line results from the study in the fourth quarter of 2018.

    “It is highly satisfying that the study is now up and running. Despite modern treatment options, a significant percentage of patients with moderate to severe active ulcerative colitis do not respond to available medical therapies, or will eventually develop loss of response to treatments or suffer from severe side effects. I see a great need for new effective and safe therapeutic options for these patients”, said Professor Raja Atreya of the University of Erlangen-Nürnberg in Germany, who enrolled the first patient and is the principle investigator of the CONDUCT study.

    “With its novel and unique mechanism of action I believe that cobitolimod has great potential as a future alternative to the biological drugs used today. Cobitolimod has shown promising results in clinical studies to date. By optimising the dosing regimen in the CONDUCT study the therapeutic effect may be even higher”, he concluded.

    Professor Walter Reinisch at the Medical University of Vienna and Medical Advisor in the study added, “Ulcerative colitis is a chronic disabling disorder that has a very negative impact on a patient’s quality of life. Cobitolimod represents a novel and promising approach to targeted treatment of the colonic inflammation. Its local application is intended to result in low risk of systemic side-effects, but a quick onset of action, both highly valued benefits by patients”.