STOCKHOLM, Oct. 5, 2023 /PRNewswire/ — InDex Pharmaceuticals Holding AB (publ) will attend the United European Gastroenterology Week (UEGW), one of the world’s leading gastroenterology congresses. UEGW is taking place October 14-17, 2023 in Copenhagen.

InDex Pharmaceuticals will be present at booth #C3-84 in the exhibition hall at the Bella Center. InDex’s team members will be available on site to provide information about cobitolimod and the ongoing phase III program CONCLUDE, which is evaluating the Toll-like receptor 9 agonist cobitolimod, as a potential novel treatment for moderate to severe left-sided ulcerative colitis. In addition, InDex’s team member will take the opportunity to meet Investigators of Induction Study 1 in the CONCLUDE program and to have meetings with the company’s key external advisors.

The positive results from the pharmacokinetic (PK) study with cobitolimod was selected by UEGW as one of the best abstracts for poster presentation and will be presented by principal investigator Professor Per Hellström on October 15 at 10:30 CET on Poster Stage 1, during the moderated poster session: “Medical therapy of IBD: Facts and challenges.”

“As one of the leading gastroenterology conferences in the world, UEGW is a great opportunity for us to interact with investigators, potential partners and the key external experts in our advisory boards,” said Jenny Sundqvist, CEO of InDex Pharmaceuticals. “The fact that the positive results from the PK-study with cobitolimod was selected as one of the best abstracts for poster presentation at UEGW, shows that there is a great interest in cobitolimod within the field.”

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]

Publication

The information was submitted for publication through the agency of the contact person set out above at 12:10 CET on October 5, 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.

About the CONCLUDE program

The phase III program CONCLUDE is evaluating cobitolimod as a novel treatment for patients with moderate to severe left-sided ulcerative colitis and consists of two sequential induction studies which both feed into a maintenance study, in which patients who have responded to cobitolimod as induction therapy, receive maintenance treatment with cobitolimod or placebo for approximately one year. Induction Study 1 will include approximately 440 patients and is evaluating two doses, 250 mg and 500 mg, given at baseline and week 3, in an adaptive study design. When 30% of the patients have completed Induction Study 1 with eligible data for the primary endpoint at week 6, an analysis will be performed to select the best dose of 250 mg and 500 mg cobitolimod. The analysis will be conducted by a DMC (Data Monitoring Committe) consisting of independent experts in the field, who will, based on pre-specified criteria, recommend which dose to continue with. In addition, the DMC will review the data for safety and futility. To maintain the integrity of the phase III program, the analysis will be completely blinded to InDex, patients and investigators. InDex will only receive information on which dose out of 250 mg and 500 mg cobitolimod that the DMC has recommended and whether the phase III program can proceed. Following the dose selection, new patients entering the study will be treated with the selected dose of cobitolimod or placebo. Upon a positive read-out of Induction Study 1, InDex plans to initiate Induction Study 2.

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.

Information in this press release is intended for investors.

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