Positive results from pharmacokinetic study with cobitolimod

“We are very excited that the pharmacokinetic study could confirm a low systemic uptake of the higher dose of 500 mg cobitolimod, and that it was well tolerated with no serious adverse events reported in the study,” said Jenny Sundqvist, CEO of InDex Pharmaceuticals. “One of the potential benefits of a locally acting treatment in the colon is low systemic exposure, and with these results we can add another building block to support our excellent safety profile.”

Period January – March 2023

  • Net sales amounted to SEK 0.0 (0.0) million
  • Operating loss amounted to SEK –44.3 (–18.9) million
  • Result after tax amounted to SEK –41.8 (–18.9) million, corresponding to SEK –0.08 per share (–0.04) before and after dilution
  • Cash flow from operating activities amounted to SEK –23.1 (–18.4) million

All comparative amounts in brackets refer to the outcome during the corresponding period 2022.

Significant events during the quarter

  • InDex updated the timeline of Induction Study 1 of the phase III program CONCLUDE with cobitolimod

Significant events after the reporting period

  • No significant events have occurred after the reporting period

Other events

  • InDex attended the annual congress of the European Crohn’s and Colitis Organisation (ECCO) in Copenhagen
  • InDex announced positive results from a pharmacokinetic (PK) study with cobitolimod

CEO statement

As I write this, spring has finally made its entrance in Sweden and the first quarter of 2023 has come to an end. My first quarter as CEO of InDex Pharmaceuticals. As I reflect, it’s been three busy and eventful months.

At the end of January, we announced a slower than expected start to the Induction Study 1 of our phase III program CONCLUDE with cobitolimod. The dose selection milestone is now expected in Q4 this year and, at that time, we will also comment on how this has affected the overall timeline of the development program. This is naturally disappointing, but the entire company, in close collaboration with our CRO, Parexel, is still fully focused on actions to increase recruitment speed in the study. To date, we are tracking well against our revised plan, and we hope to continue this momentum over the summer months as well. We are solely determined on just getting it done! We have an open and frequent dialogue with investigators around the world in the 30 countries participating in our study. And I must send a special shout out to our Ukrainian clinics who are displaying such commitment and resilience despite tough circumstances.

In March, we announced the results of our phase Ib pharmacokinetic (PK) study. The aim of the study was to measure the systemic uptake of cobitolimod. Our hope was to further solidify cobitolimod’s excellent safety profile by showing a low systemic uptake both during flare and remission. The study results are required as part of the market authorization file to be submitted upon successful completion of our phase III program. The study was conducted with the highest dose of cobitolimod used in the phase III program, 500 mg. Not only did the study confirm the low systemic uptake of cobitolimod, adding another building block to our excellent safety profile; but we also noted that 4 out of 7 patients went into remission. Although we cannot draw any efficacy conclusions from this result, given that it’s an open label study with very few patients, it’s an encouraging sign.

I would also like to comment on the team at InDex after having worked together for three months. It’s not a company like all others. Sure, most companies claim to be entrepreneurial, innovative, engaged, be built on a team culture and always put the patients first. And so do we. I don’t mean to discredit any of these values, they are important and critical for success, however, I’ve noted genuine warmth, support and joy at InDex – and I truly appreciate that. This is hard to find, and it makes going to work so much more enjoyable and gratifying. I’m a true believer that you should enjoy your job. If you do, you’re much more likely to deliver and succeed.

As a last note, I would like to thank all investors who contribute with their feedback and thoughts on our communications. It’s very helpful to hear what you appreciate and what you’d like to know more about. Keeping in line with regulations and best practice, I will do my utmost to be clear and transparent in all communications moving forward.

Jenny Sundqvist, CEO

For more information:
Jenny Sundqvist, CEO
Phone: +46 8 122 038 50
E-mail: [email protected]

Johan Giléus, deputy CEO and CFO
Phone: +46 8 122 038 50
E-mail: [email protected]

The full report is attached as a PDF and is available on the company’s website https://www.indexpharma.com/en/financial-reports/

This information is information that InDex Pharmaceuticals Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (MAR). The information was submitted for publication through the agency of the contact person set out above at 8:00 CET on May 24, 2023.

This is an English translation of the Swedish press release. In case of discrepancies between the English translation and the Swedish press release, the Swedish press release shall prevail.

InDex Pharmaceuticals in brief
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 being evaluated in the phase III program CONCLUDE as a novel 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.

InDex is based in Stockholm, Sweden. The company’s shares (ticker INDEX) are traded on Nasdaq First North Growth Market Stockholm. Redeye AB is the company’s Certified Adviser. For more information, please visit www.indexpharma.com.