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InDex Pharmaceuticals receives FDA clearance to start the phase III study CONCLUDE with cobitolimod

August 24, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that the U.S. Food and Drug Administration (FDA) has given clearance to start the phase III clinical study CONCLUDE in the United States. The study will evaluate the efficacy and safety of the first-in-class TLR9 agonist cobitolimod for the treatment of moderate to severe left-sided ulcerative colitis.“The United States is the largest pharmaceutical market in the world, and to receive clearance from the FDA  to start the phase III study CONCLUDE with cobitolimod is an important milestone for InDex,” said Peter

InDex Pharmaceuticals Holding AB (publ) interim report January – March 2020

FDA and EMA endorse the advancement of cobitolimod into phase III studies“The positive responses from the regulators is an important external validation of our study results and cobitolimod’s potential,” says Peter Zerhouni, CEO of InDex Pharmaceuticals. Period January – March 2020 · Net sales amounted to SEK 0.0 (0.0) million · Operating loss amounted to SEK –24.0 (–17.2) million · Result after tax amounted to SEK –24.0 (–17.2) million, corresponding to SEK –0.27 per share (–0.25) before and after dilution · Cash flow from operating activities amounted to SEK –21.9 (–18.4)

InDex Pharmaceuticals advances cobitolimod further towards phase III following successful interactions with FDA and EMA

April 16, 2020 – InDex Pharmaceuticals Holding AB (publ) today announced that the company has received positive responses from FDA and EMA regarding phase III development of the company's TLR9 agonist cobitolimod, for the treatment of moderate to severe ulcerative colitis. The company is continuing its phase III preparations, including efforts to secure financing.Following the phase IIb study CONDUCT meeting its primary endpoint in August 2019, dialogues were initiated with FDA and EMA respectively, for the further development of cobitolimod. These processes have now been completed and both

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