Press releases

InDex Pharmaceuticals discontinues cobitolimod phase III program

· Independent Data Monitoring Committee (DMC) advises that cobitolimod is unlikely to meet the primary endpoint upon completion of Induction Study 1
· More information regarding next steps will be provided once a thorough analysis of the data from Induction Study 1 has been completed

21 November, 2023 – InDex Pharmaceuticals Holding AB (publ) (“InDex Pharmaceuticals”) today announces that an independent DMC has completed the planned dose selection analysis including safety review and assessment for futility in Induction Study 1 of the phase III program CONCLUDE. The DMC advises that cobitolimod is unlikely to meet the primary endpoint upon completion of Induction Study 1. The advice to stop the study was not based on safety concerns.

October 30, 2023 – InDex Pharmaceuticals Holding AB (publ) today announced the composition of the Nomination Committee for the 2024 Annual General Meeting. The responsibility of the Nomination Committee is to present to the 2024 Annual General Meeting proposals regarding election of the Chairman of the Board and other members of the Board, fees and any other remuneration to the members of the Board as well as election and remuneration of the auditors.

October 20, 2023 – InDex Pharmaceuticals Holding AB (publ) today announced that a new method of use patent for the drug candidate cobitolimod has been granted by the Korean Intellectual Property Office. The patent provides protection for the use of cobitolimod in the treatment of inflammatory bowel disease.

October 11, 2023 – InDex Pharmaceuticals Holding AB (publ) today announced that 30% of patients have completed the final visit in Induction Study 1 of the phase III program CONCLUDE, which is evaluating cobitolimod as a novel treatment for patients with moderate to severe, left-sided ulcerative colitis. The outcome of the cobitolimod dose selection analysis will be presented in Q4 this year according to plan.

October 5, 2023 – 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.

License agreement signed with Viatris Japan

August 22, 2023 – InDex Pharmaceuticals Holding AB (publ) today announced that the positive results from the pharmacokinetic (PK) study with cobitolimod in patients with moderate to severe ulcerative colitis will be presented at one of the leading gastroenterology conferences, the United European Gastroenterology Week (UEGW). The abstract was selected as one of the best abstracts for poster presentation and is therefore also chosen to be presented orally in one of the moderated poster sessions.

August 2, 2023 – InDex Pharmaceuticals Holding AB (publ) today announced that a new formulation patent for the drug candidate cobitolimod has been granted by the European Patent Office. The patent provides protection of the enema formulation of cobitolimod, that is currently under evaluation in the ongoing phase III program CONCLUDE.

May 31, 2023 – InDex Pharmaceuticals Holding AB (publ) will hold an investor call in light of today’s press release announcing the company’s license agreement. The investor call will take place on June 1, 2023 at 15:00 CET via MS Teams.

May 31, 2023 – InDex Pharmaceuticals Holding AB (publ) (“InDex”) today announced that a license agreement has been signed with Viatris Pharmaceutical Japan Inc. (“Viatris Japan”) to register and commercialize cobitolimod in Japan for the treatment of ulcerative colitis. Cobitolimod is a TLR9 agonist which is being evaluated in the global phase III program CONCLUDE, as a novel treatment for moderate to severe ulcerative colitis. The agreement including milestones is worth up to USD$50m, excluding royalties.

May 24, 2023 – The annual general meeting in InDex Pharmaceuticals Holding AB (publ) was held on Wednesday 24 May 2023. The following resolutions, amongst others, were passed at the general meeting.

Positive results from pharmacokinetic study with cobitolimod

April 26, 2023 – InDex Pharmaceuticals Holding AB (publ) invites investors, analysts and media to attend a live business update during which Jenny Sundqvist, CEO, and the InDex Pharmaceuticals leadership team will share insights and updates on the company’s mission to improve the lives of patients suffering from immunological diseases. Focus will be on the ongoing phase III program CONCLUDE with the company’s lead asset, cobitolimod – a potential new medication for patients with ulcerative colitis.

N.B. This English text is an unofficial translation of the Swedish original of the notice to attend the annual general meeting. In case of any discrepancies between the Swedish and English language versions, the Swedish version shall prevail.

April 19 2023 – Shareholders in InDex Pharmaceuticals Holding AB, reg. nr 559067-6820 (the “Company”), are hereby summoned to the Annual General Meeting on Wednesday May 24, 2023 at 17.00 (CET) at Setterwalls Advokatbyrå’s offices at Sturegatan 10 in Stockholm. Registration for the meeting commences at 16.30 (CET).

April 12, 2023 – InDex Pharmaceuticals Holding AB (publ) today publishes the Annual Report for 2022. The Annual Report is attached as a PDF and is available on the company’s website, https://www.indexpharma.com/en/financial-reports/.

March 15, 2023 – InDex Pharmaceuticals Holding AB (publ) today announced positive results from a pharmacokinetic (PK) study with cobitolimod in patients with moderate to severe ulcerative colitis. The systemic uptake was limited both for patients with active disease and in clinical remission. For the first time patients have been treated with doses of 500 mg, and in line with previous studies cobitolimod was well tolerated.

February 27, 2023 – InDex Pharmaceuticals Holding AB (publ) today announced that the company will attend the annual congress of the European Crohn’s and Colitis Organisation (ECCO), March 1-4, 2023 in Copenhagen. ECCO is the largest forum for specialists in inflammatory bowel disease globally.

PK Study fully recruited

February 14, 2023 – InDex Pharmaceuticals Holding AB (publ) is today making a presentation with CEO Jenny Sundqvist available in light of the press release issued January 27, 2023 regarding the updated timeline of the CONCLUDE program.

January 27, 2023 – InDex Pharmaceuticals Holding AB (publ) today announced an update in the timing of the dose selection in the ongoing phase III study CONCLUDE with the drug candidate cobitolimod. The outcome of the dose selection is expected to be available Q4 2023. At that point in time InDex will have finalised the assessments of consequences on the overall development timeline including topline results in CONCLUDE.