November 24, 2021

We have now several clinics activated in the phase III study CONCLUDE and look forward to enrol the first patient in the near term. We are pushing hard to get more and more clinics ready to enrol patients as we receive regulatory approval to start the study in the respective countries. We have already approval in the US, Sweden, Hungary, and France, and expect approval in several more countries in the coming weeks.

CONCLUDE is a global clinical study, which will include 440 participants to evaluate cobitolimod as a new treatment for patients with moderate to severe left-sided ulcerative colitis. The study will be conducted at several hundred clinics in over 30 countries.

The pandemic continues to affect the start-up of new clinical studies in that the clinics report resource constraints and a need to prioritize their regular care and to manage the backlog. Once our study is up and running, we expect to reach the planned patient recruitment rate.

There continues to be a lot of news coming out of the field of ulcerative colitis. It was quite dramatic in September when the FDA updated their safety warnings for JAK inhibitors as a class. The FDA added serious heart-related events, cancer, blood clots, and death to the already boxed warnings of JAK inhibitors. They also limited all approved uses to patients who have failed TNF blockers. FDA’s decision firmly positions the JAK inhibitors as a last line treatment in ulcerative colitis. It is a reminder that a product’s safety profile is very important, and good news for cobitolimod that has demonstrated an excellent safety profile to date. Overall, the competitive landscape has clearly evolved in cobitolimod’s favour over the last 18 months.

We recently got a new patent for cobitolimod granted in the US, which is the most important pharmaceutical market in the world. This new patent provides protection for the 250 mg dose, which was successful in the phase IIb study CONDUCT and is now included in phase III. The patent will provide an exclusivity period until May 2038, with the possibility of up to 5 years term extension after market approval. It is a good example of our IP strategy to build a thicket of patents around cobitolimod. We continue to file new patent applications in the light of advances in the formulation and clinical development of cobitolimod, to provide exclusivity beyond the term of InDex’s already granted patents.

I am excited that we are close to enrol the first patient in the phase III study and I hope you will tune in to our upcoming investor presentations at HC Andersen Capital today and Erik Penser Bank tomorrow.

Peter Zerhouni, CEO of InDex Pharmaceuticals