August 23, 2023
Q2 this year was dominated by our exciting license agreement with Viatris Japan that we signed on May 31. Viatris is a global pharmaceutical company with over 37,000 employees in >165 countries. Viatris was formed in 2020 through the combination of Mylan and Upjohn. Gastroenterology is one of Viatris Japan’s three key therapy areas in which they have a solid knowledge and presence. This will enable us to jointly maximize the potential of cobitolimod. We are thrilled to start our collaborative journey with Viatris Japan and work together to significantly improve the lives of patients suffering from ulcerative colitis.
Our active outreach strategy for the Japanese market was based on the unique decision by the Japanese regulatory authority (PMDA) in August 2022 to allow us to include Japanese patients in our phase III program without conducting a pharmacokinetic study on Japanese patients beforehand. This decision is testimony to the PMDA’s comfort with the safety profile of cobitolimod. Discussions with potential partners were further accelerated when we, in mid-March 2023, reported positive results from our pharmacokinetic study in Sweden confirming a low systemic uptake of cobitolimod. Even though it was a small-scale open-label study, it was encouraging that 4 out of 7 patients achieved clinical remission at week 6. From that point on, discussions with Viatris intensified, resulting in a common belief in cobitolimod’s potential.
The license agreement gives Viatris Japan the right to register and commercialize cobitolimod in Japan for the treatment of ulcerative colitis. An upfront fee of USD 10 million was received the day after signing the agreement. In addition, the deal includes development and sales milestone payments of up to USD 40 million and up to double-digit percentage royalties based on net product sales.
On May 9, we provided a general business update on InDex and our phase III program CONCLUDE. This was very well received by those who participated. If you did not have the chance to participate, you can see the presentations on https://www.redeye.se/video/event-presentation/905259/index-pharmaceuticals-businessupdate-may-9-2023?embed.
Looking forward to Q3, we are expecting to have recruited 30% of patients in Induction Study 1. This is the percentage needed to perform the dose selection analysis to be announced in Q4. I’m happy to say that our efforts to speed up our phase III program are paying off and we are proceeding according to plan towards the dose selection milestone.
There are two pieces of information that this milestone will give us:
1. Whether or not we can continue our phase III program as planned.
2. What dose (250 or 500 mg) of cobitolimod should be used for the remainder of the program.
Out of the above, the first one is by far the most important decision. Our goal is to launch a treatment that provides at least comparable efficacy to already approved drugs (10-15% delta in clinical remission) but doing so with a unique safety profile.
Cobitolimod has the potential to become the first advanced therapy for moderate to severe left-sided ulcerative colitis with no serious adverse safety concerns. This would make us truly exceptional and would be our key selling point. As such, if we get the news to proceed with the study and that no safety concerns have been noted, we would be truly satisfied, irrespective of what dose is chosen.
It’s important to point out the dose selection milestone is a blinded analysis. No efficacy data will be available to InDex nor to investigators or patients.
Upon finishing a highly successful Q2, I’m looking forward to an exciting second half of the year and working effectively towards our next milestone.
Jenny Sundqvist, CEO