August 25, 2021
We are now close to the start of the phase III study CONCLUDE to evaluate cobitolimod as a new treatment for patients with moderate to severe left-sided ulcerative colitis. It is a global clinical study which will include 440 participants and 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, and in July we received the first regulatory approval to start the study from the Swedish MPA and yesterday from the US FDA.
We will initiate patient recruitment when the clinics are up and running again after the summer as the healthcare situation has started to normalise. Together with our CRO we are finalising the practical preparations.
To strengthen our clinical development organisation, we have hired two new employees, Anders Bröijersén as Senior Medical Director Clinical Operations and Johan Levin as Project Manager Clinical Operations. Both have long and broad experience of clinical development and conducting clinical studies. I am pleased that we have been able to attract two such qualified employees and welcome Anders and Johan to the team. Much of their time will be devoted to support the clinics in the study as ambassadors for InDex and the CONCLUDE study, which was a successful model for patient recruitment in our previous study CONDUCT.
In parallel with the phase III study, we will conduct a smaller clinical pharmacokinetic study (PK study) with cobitolimod in Sweden. We have received approval from the Swedish MPA to start also this study. The purpose of the study is to evaluate the systemic uptake of cobitolimod, and the data will support future regulatory applications for market approval of cobitolimod. Previous preclinical and clinical studies have shown that the systemic uptake of cobitolimod is very limited, which likely contributes to the excellent safety profile. This is a significant advantage compared to the current systemically administered drugs for ulcerative colitis that can cause severe off-target effects.
Besides cobitolimod for ulcerative colitis, InDex has a preclinical portfolio of more than 150 DNA-based ImmunoModulatory Sequences (DIMS), of which we are testing a selected number of candidates in models of other inflammatory diseases. In April, a new European patent was granted that provides protection for 19 different DIMS substances. This patent has previously been granted in the US and Canada, and we are very pleased that also the European Patent Office confirms the novelty of our DIMS platform.
In June, we had the Annual General Meeting and although we had postponed it as much as possible, we were unfortunately not able to welcome the shareholders to a physical meeting this year either. On September 2, I will present the company at the Pareto Securities Healthcare Conference, which will be held virtually also this year.
Soon I hope we can start meeting each other in person again and I look forward to welcoming the first patient in the phase III study CONCLUDE.
Peter Zerhouni, CEO of InDex Pharmaceuticals