InDex Pharmaceuticals receives first regulatory approval to start the phase III study CONCLUDE with cobitolimod
STOCKHOLM, July 21, 2021 /PRNewswire/ -- InDex Pharmaceuticals Holding AB (publ) today announced that the Swedish Medical Products Agency (MPA) has given approval to start the phase III clinical study CONCLUDE in Sweden. 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.
"We are very pleased to have received approval from the MPA to start the phase III study CONCLUDE with cobitolimod, and we plan to initiate patient recruitment in Sweden and other countries after the summer," said Peter Zerhouni, CEO of InDex Pharmaceuticals. "This first regulatory approval to start the phase III study marks a significant step towards providing a new type of treatment to patients suffering from ulcerative colitis, which is a debilitating disease with an enduring unmet medical need".
CONCLUDE is a global phase III study that will be conducted at several hundred clinics in over 30 countries. The process of applying for and obtaining approval from the relevant authorities in the participating countries is ongoing. It is a randomised, double-blind, placebo-controlled, clinical study to evaluate cobitolimod as a novel treatment for patients with moderate to severe left-sided ulcerative colitis.
The induction study will include 440 patients, and the primary endpoint will be clinical remission at week 6. Apart from the dosing 250 mg x 2, which was the highest dose and the one that showed the best efficacy in the phase IIb study CONDUCT, the phase III study will also evaluate a higher dose, 500 mg x 2, in an adaptive study design. Patients responding to cobitolimod in the induction study will be eligible to continue in a one-year maintenance study, where they will be treated with either cobitolimod or placebo.
For more information:
Cobitolimod in brief
InDex Pharmaceuticals in brief
InDex is based in Stockholm, Sweden. The company's shares (ticker INDEX) are traded on Nasdaq First North Growth Market. Redeye AB with email address firstname.lastname@example.org and phone number +46 8 121 576 90 is the company's Certified Adviser. For more information, please visit www.indexpharma.com.
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SOURCE Index Pharmaceuticals
Company Codes: ISIN:SE0008966295, Stockholm:INDEX