February 23, 2023
I joined InDex in January and was met by a highly motivated, committed, and knowledgeable team. 2022 may have been a year of changes in the company, but that has not affected the engagement of the team! At the end of January, we got confirmation that it would not be possible to off-set the slow start to Induction Study 1 in our CONCLUDE phase III program that was seen in 2022. A delay was communicated, and we will revert in Q4 2023 with an updated overall timeline that will include our major milestones on our development journey, including top-line results of Induction Study 1. We also announced that the dose selection milestone is now expected to occur in Q4 2023.
Although we flagged for the slower than expected start-up of Induction Study 1 in our Q3 report, it is naturally a disappointment that we did not catch up to meet our initial timeline. However, the excellent potential and key strengths of cobitolimod remain unchanged. We have complete focus on increasing the speed of site and patient recruitment and look forward to seeing the results of our action plan bear fruit in 2023. We are particularly happy that clinics in the Ukraine are now up and running and highly engaged. Our first patients from the Ukraine were randomized into Induction Study 1 early 2023. For more information to investors on patient recruitment and the actions we have taken to speed up the process, please visit https://www.indexpharma.com/en/presentations/
In the beginning of October, InDex participated as an exhibitor at the United European Gastroenterology Week (UEGW) in Vienna, the largest scientific meeting for gastroenterologists in Europe. There was a considerable interest in cobitolimod and our CONCLUDE program, with many visitors at our booth, both from clinics already participating in our study and from new clinics expressing interest to join. Given the EMA’s safety committee recommendation of new measures for the use of JAK inhibitors due to their risk of severe side effects in October 2022, we see a clear interest and need for safer treatment options for patients.
In 2023, we look forward to announcing the results of our PK Study which is on plan to report in Q1. The purpose of the study is to evaluate the systemic uptake of cobitolimod. The results will include PK data from 7 patients with moderate to severe ulcerative colitis treated with doses of 500 mg of cobitolimod administered rectally.
We are also geared up for the ECCO (European Crohn’s and Colitis Organisation) congress taking place in Copenhagen in early March 2023 where we will be present with a booth and have several key meetings set up with investigators participating in our CONCLUDE program.
I look forward to a productive 2023 with fruitful interactions with health care professionals, potential partners and investors.
Jenny Sundqvist, CEO