Business Insights

InDex Pharmaceuticals strengthens the clinical development organization in preparation of the start of the phase III study CONCLUDE with cobitolimod

InDex Pharmaceuticals Holding AB today announced that two new employees have been appointed in the clinical development organisation in preparation of the start of the phase III study CONCLUDE with cobitolimod.

Anders Bröijersén is joining InDex as Senior Medical Director Clinical Operations and Johan Levin as Project Manager Clinical Operations.

Anders Bröijersén is a medical doctor and PhD with 15 years of experience in Clinical Development, Medical Affairs and Drug Safety at leading pharmaceutical companies such as Boehringer Ingelheim and MSD. Anders joins InDex from Sobi where he currently serves as Medical Director, Global Pharmacovigilance & Patient Safety.

Johan Levin is a trained nurse and has more than 20 years of experience in Clinical Development at leading pharmaceutical companies and clinical research organizations (CROs) such as MSD and Covance. He currently works as senior Clinical Research Associate (CRA) at PRA Health Sciences.

"I am pleased that InDex has been able to attract two highly qualified new employees and welcome Anders and Johan to the team," said Peter Zerhouni, CEO of InDex Pharmaceuticals. "We are expanding the organisation in preparation of the start of our global phase III study CONCLUDE with cobitolimod to be able to be active towards the study sites in collaboration with our CRO. This was a successful model for patient recruitment in our previous study CONDUCT."

The phase III study CONCLUDE with cobitolimod will include 440 patients and be conducted at several hundred clinics in over 30 countries. 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.

Cobitolimod 
Cobitolimod is a first-in-class Toll-like receptor 9 (TLR9) agonist that 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. Cobitolimod met the primary endpoint in the phase IIb study CONDUCT and demonstrated an outstanding combination of efficacy and safety. The results have been published in the reputable medical journal, The Lancet Gastroenterology & Hepatology. Data from four previous completed placebo-controlled clinical trials support the efficacy and safety demonstrated in the CONDUCT study.

InDex Pharmaceuticals
InDex is a pharmaceutical development company focusing on immunological diseases where there is a high unmet medical need for new treatment options. The company's lead asset is the drug candidate cobitolimod, which is in late stage clinical development for the treatment of moderate to severe ulcerative colitis – a debilitating, chronic inflammation of the large intestine. InDex has also developed a platform of patent protected discovery stage substances, so called DNA based ImmunoModulatory Sequences (DIMS), with the potential to be used in the treatment of various immunological diseases.

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