Press releases

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.

The Board has appointed Jenny Sundqvist as new CEO

October 26, 2022 – InDex Pharmaceuticals Holding AB (publ) today announced the composition of the Nomination Committee for the 2023 Annual General Meeting. The responsibility of the Nomination Committee is to present to the 2023 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 10, 2022 – InDex Pharmaceuticals Holding AB (publ) today announced that the Board of Directors has named Jenny Sundqvist as new CEO. Jenny comes from a position as Chief Commercial Officer at Isofol Medical AB and has broad experience from leading positions within the pharmaceutical industry. Johan Giléus, who has been acting CEO since April 2022, will continue as CFO in the company.

October 5, 2022 – InDex Pharmaceuticals Holding AB (publ) today announced that the company will be exhibiting at the United European Gastroenterology Week (UEGW) October 8-11, 2022 in Vienna. UEGW is the largest scientific meeting for gastroenterologists in Europe.

PMDA supports InDex’s development plan for cobitolimod in Japan

16 August, 2022 – InDex Pharmaceuticals Holding AB (publ) today announced that the company has received positive feedback from the Japanese regulatory authority, the Pharmaceuticals and Medical Devices Agency (PMDA), regarding the clinical development plan for a future marketing authorization application for the company’s TLR9 agonist cobitolimod, for the treatment of moderate to severe left-sided ulcerative colitis. The PMDA has accepted enrolment of Japanese ulcerative colitis patients in the second global phase III induction study, without performing specific Japanese studies prior to study start.

July 13, 2022 – InDex Pharmaceuticals Holding AB (publ) today announced that a new method of use patent for the drug candidate cobitolimod has been granted by the European Patent Office (EPO). The patent provides additional protection for the use of cobitolimod in the treatment of inflammatory bowel disease.

June 1, 2022 – The annual general meeting in InDex Pharmaceuticals Holding AB (publ) was held on Wednesday 1 June 2022. The following resolutions, amongst others, were passed at the general meeting:

Full focus on the phase III study CONCLUDE with cobitolimod

May 12, 2022 – InDex Pharmaceuticals Holding AB (publ) today announced that the company will be exhibiting at the Digestive Disease Week (DDW) May 21-24, 2022 in San Diego. DDW is the world’s premier meeting for healthcare professionals, researchers and industry in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

May 2, 2022 – InDex Pharmaceuticals Holding AB (publ) today announced that the company has appointed Eva Arlander as Chief Development Officer. Eva will also be part of the management team, together with acting Chief Executive Officer and Chief Financial Officer Johan Giléus, Chief Medical Officer Anders Bröijersén and Chief Scientific Officer Charlotte Admyre.

28 April 2022 – Shareholders in InDex Pharmaceuticals Holding AB, reg. nr 559067-6820 (the “Company”), are hereby summoned to the Annual General Meeting on Wednesday 1 June, 2022 at 17.00 (CET) through advance voting. Attendance at the meeting is only possible via postal ballot.

April 11, 2022 – InDex Pharmaceuticals Holding AB (publ) today announced that after more than seven years as CEO, Peter Zerhouni has decided to leave his position. The company’s CFO Johan Giléus has been appointed acting CEO while a new CEO is being recruited, and he will also continue as CFO.

April 8, 2022 – InDex Pharmaceuticals Holding AB (publ) today publishes the Annual Report for 2021. The Annual Report is attached as a PDF and is available on the company’s website, https://www.indexpharma.com/en/financial-reports/.

March 13, 2022 – InDex Pharmaceuticals Holding AB (publ) is planning for self-commercialisation of the drug candidate cobitolimod in the US with strategic collaborations in other regions. Launch is expected in 2027, with the potential for annual sales to reach more than USD 1 billion, in moderate to severe left-sided ulcerative colitis. An in-depth presentation of the strategy and market potential, together with the execution of the phase III study CONCLUDE with cobitolimod will be provided at InDex’s Capital Markets Day, tomorrow March 14, 15.00-17.00 CET.

March 7, 2022 – InDex Pharmaceuticals Holding AB (publ) invites investors, analysts and media to a Capital Markets Day on March 14, 2022. The Capital Markets Day will be held in Krügersalen at Kapitel 8, Tändstickspalatset, Västra Trädgårdsgatan 15 in Stockholm. The presentations will start at 15.00 CET with registration from 14.30 CET.

First patient enrolled in the phase III study CONCLUDE

February 15, 2022 – InDex Pharmaceuticals Holding AB (publ) invites investors, analysts and media to a Capital Markets Day on March 14, 2022. The Capital Markets Day will be held in Krügersalen at Kapitel 8, Tändstickspalatset, Västra Trädgårdsgatan 15 in Stockholm. The presentations will start at 15.00 CET with registration from 14.30 CET.

February 13, 2022 – InDex Pharmaceuticals Holding AB (publ) today announced that Chief Operating Officer Pernilla Sandwall has decided to leave the company to become CEO of WntResearch. She will continue in her current role until the end of April. The process to recruit her successor will be initiated immediately.

December 8, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that the first patient has been enrolled in the clinical pharmacokinetic study (PK study) with cobitolimod. The purpose of the study is to evaluate the systemic uptake of cobitolimod in local treatment of colonic inflammation.

November 24, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that the first patient has been enrolled in the pivotal phase III study CONCLUDE. The study will evaluate the efficacy and safety of the first-in-class TLR9 agonist cobitolimod as a novel treatment for patients with moderate to severe left-sided ulcerative colitis.

Ready to initiate patient recruitment in phase III study CONCLUDE

November 16, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that a new method of use patent for the drug candidate cobitolimod has been granted by the Canadian Intellectual Property Office (CIPO). The patent provides additional protection for the use of certain dosage regimens of cobitolimod for treating chronic active ulcerative colitis in patients that are not responding or are intolerant to anti-inflammatory therapy.

November 10, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced the composition of the Nomination Committee for the 2022 Annual General Meeting. The responsibility of the Nomination Committee is to present to the 2022 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.

November 9, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that a new method of use patent for the drug candidate cobitolimod has been granted by the United States Patent and Trademark Office (USPTO). The patent provides protection for the use of certain dosage regimens of cobitolimod for treating inflammatory bowel disease, including the 250 mg dose which was successful in the phase IIb study CONDUCT.

November 8, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that CEO Peter Zerhouni will present the company at Redeye Life Science Day 2021 on November 11 at 09.00 CET. The presentation will be livestreamed and can be followed at https://www.redeye.se/events/815899/redeye-life-science-day-2021.

First regulatory approvals to start the phase III study CONCLUDE

August 24, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that the U.S. Food and Drug Administration (FDA) has given clearance to start the phase III clinical study CONCLUDE in the United States. The study will evaluate the efficacy and safety of the first-in-class TLR9 agonist cobitolimod for the treatment of moderate to severe left-sided ulcerative colitis.

August 23, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that two new employees have been appointed in the clinical development organisation in preparation of the start of the phase III study CONCLUDE with cobitolimod.

August 19, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that the company will conduct a clinical pharmacokinetic study (PK study) with cobitolimod in Sweden. The Swedish Medical Products Agency has given approval to start the study.

July 21, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that the Swedish Medical Products Agency (MPA) has given approval to start the phase III clinical study CONCLUDE in Sweden. The study will evaluate the efficacy and safety of the first-in-class TLR9 agonist cobitolimod for the treatment of moderate to severe left-sided ulcerative colitis.

June 3, 2021 – The annual general meeting in InDex Pharmaceuticals Holding AB (publ) was held on Thursday June 3, 2021. The following resolutions, amongst others, were passed at the general meeting:

May 31, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that patient recruitment for the phase III study CONCLUDE is planned to initiate after the summer. The study will evaluate the efficacy and safety of the drug candidate cobitolimod for the treatment of moderate to severe left-sided ulcerative colitis.

May 27, 2021 – InDex Pharmaceuticals Holding AB (publ) today announced that CEO Peter Zerhouni will present the company at Redeye Growth Day 2021 on June 2 at 8.50 CET. The presentation will be livestreamed and can be followed at https://www.redeye.se/events/808637/redeye-growth-day-2021.

The crucial pieces of the puzzle in place for the start of phase III

May 4, 2021 – Shareholders in InDex Pharmaceuticals Holding AB, reg. nr 559067-6820 (the “Company”), are hereby summoned to the Annual General Meeting on Thursday 3 June, 2021 at 17.00 (CET) through advance voting. Attendance at the meeting is only possible via postal ballot.

April 23, 2021 – InDex Pharmaceuticals Holding AB (publ) today publishes the Annual Report for 2020. The Annual Report is attached as a PDF and is available on the company’s website, https://www.indexpharma.com/en/financial-reports-and-presentations/.

November 18, 2019 – InDex Pharmaceuticals Holding AB (publ) today announced that CEO Peter Zerhouni will present the company at Redeye Life Science Day at ROOTS@Downtown Camper by Scandic, Drottninggatan 28 in Stockholm at 08:35 CET and at Avanza Börsdag at Operaterrassen, Karl XII:s torg in Stockholm at 11:15 CET on November 19. Both presentations will be livestreamed.

Novel formulation for oral administration of cobitolimod

August 9, 2017 – InDex Pharmaceuticals Holding AB (publ) today announced that the US Food and Drug Administration (FDA) has granted orphan-drug designation for the drug candidate cobitolimod for treatment of ulcerative colitis in pediatric patients.

April 27, 2017 – Shareholders in InDex Pharmaceuticals Holding AB, reg. nr 559067-6820, are hereby summoned to the Annual General Meeting on Tuesday, May 30, 2017 at 5:00 p.m. (CET) at the company´s premises, Tomtebodavägen 23a in Stockholm, Sweden. Registration for the meeting begins at 4:30 p.m.

Initial public offering and listing on Nasdaq First North Stockholm Period July – September 2016  Revenues amounted to MSEK 0.0 (0.0)  Operating result amounted to MSEK -6.6 (-7.5)  Result after…

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August 19, 2016 – The Board of InDex Pharmaceuticals today announced its intention to proceed with an Initial Public Offering of the drug development company on Nasdaq First North during the autumn. A new share issue in order to raise capital for the development of the company’s lead drug candidate – cobitolimod – is planned in connection with the listing.

July 13, 2016 – InDex Pharmaceuticals AB today announced the publication of the results from COLLECT, a clinical study of the Toll-like receptor 9 (TLR9) agonist cobitolimod as a first-in-class treatment for patients with moderate to severe ulcerative colitis (UC). The paper, published in the peer-reviewed Journal of Crohns and Colitis (JCC), supports the potential of cobitolimod as a novel treatment for moderate to severe active ulcerative colitis.

May 23, 2016 – InDex Pharmaceuticals AB today announced it has been granted 1.825 million SEK from Sweden´s innovation agency Vinnova to develop new, more effective and safer treatments for inflammatory diseases. Of 535 applications and 84 funded projects, InDex received one of the largest grants.

March 7, 2016 – InDex Pharmaceuticals AB today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application to initiate a phase IIb study with its lead drug candidate cobitolimod (Kappaproct®) in patients with moderate to severe ulcerative colitis (UC).

February 10, 2016 – InDex Pharmaceuticals AB today announced that the World Health Organization (WHO) has recommended cobitolimod as the International Nonproprietary Name (INN) for Index´s lead drug candidate Kappaproct®, which is a first-in-class Toll-like receptor (TLR) 9 agonist in late-stage clinical development for moderate to severe ulcerative colitis.

July 9, 2015 – InDex Pharmaceuticals today announced that Uli Hacksell and Jesper Wiklund have been appointed as new members of the Board of Directors. Professor Hacksell and Mr Wiklund together bring to InDex over 40 years of senior management experience from the life sciences industry in drug development, commercial operations, and business development.

June 30, 2015 – InDex Pharmaceuticals today announced the termination of a license agreement with Almirall S.A. relating to the drug candidate Kappaproct® for the treatment of ulcerative colitis. Under the agreement, which was signed in March 2014, Almirall licensed exclusive rights to Kappaproct® for the European market. Upon termination of the agreement, InDex regains all worldwide development and commercialization rights for Kappaproct®, which is in late-stage clinical development.

February 5th, 2015 – InDex Pharmaceuticals today announced that the Board of Directors has named Peter Zerhouni as new CEO. Peter Zerhouni comes from a position as CEO at Diamyd Medical AB where he has been instrumental in bringing the company’s business and clinical trials forward. He will succeed Jesper Wiklund, who has led the company since 2011.

February 3rd, 2015 – InDex Pharmaceuticals today announced that results from COLLECT, a clinical study of the toll-like receptor 9 (TLR9) agonist Kappaproct as an add-on therapy for patients with moderate to severe, chronic active Ulcerative Colitis, will be subject to an oral presentation at the 10th Congress of the European Crohn’s and Colitis Organisation (ECCO). The congress is to be held in Barcelona, Spain on February 18-21, 2015.

June 27, 2014 – InDex Pharmaceuticals today reported top-line results from the double blind, placebo-controlled clinical study COLLECT. The aim of the COLLECT study was to investigate the therapeutic potential of the Toll-like receptor 9 agonist Kappaproct as an add-on therapy for patients with moderate to severe, chronic active Ulcerative Colitis.

Patients treated with Kappaproct showed statistically significant improvement on symptomatic remission (blood in stool, number of stools), registration remission (clinical remission with concurrent endoscopic remission) and the rate of colectomy. The rate of clinical remission (Rachmilewitz Index) was high in both the Kappaproct and the control group and no statistically significant difference was observed on this measure. Kappaproct was well tolerated and no safety signals compared to the standard of care treatment group were evident.

April 1st, 2014 ­ InDex Pharmaceuticals and Almirall announced today that they have signed a license agreement for the European marketing rights to the drug candidate Kappaproct. Under the terms of…

InDex Pharmaceuticals today announced the successful closing of a USD 20 million / EUR 15 million new rights issue. NeoMed led the oversubscribed financing round while current shareholders participated with 75% of the invested capital.

Stockholm, April 8, 2013 – InDex Pharmaceuticals today announced the completion of patient enrollment for its Phase III COLLECT study of Kappaproct. The multinational, randomized, double- blind,…

Stockholm, October 24, 2012 – InDex Pharmaceuticals today announced that it has been granted a Japanese patent by the Japan Patent Office (JPO). The patent provides protection for the use of…

– Novel patent for Phase III lead drug candidate filed in the EU, US – Stockholm, August 30, 2012 – InDex Pharmaceuticals today announced the filing of a new patent with the United States Patent…

– InDex Pharmaceuticals reports positive clinical data in peer-reviewed journal Inflammatory Bowel Diseases – Stockholm, June 19, 2012 – InDex Pharmaceuticals today announced the publication of…

Former Lundbeck Executive Brings Strong Commercial Experience and Extensive Pharmaceutical Industry Network Stockholm, May 29, 2012 – InDex Pharmaceuticals today announced that Stig Løkke Pedersen…

Stockholm, April 26, 2012 – InDex Pharmaceuticals today announced that it has been granted a patent by the United States Patent and Trademark Office (USPTO). The patent provides additional…

InDex Pharmaceuticals Names Pernilla Sandwall Head of Clinical Operations and Thomas Knittel Chief Medical Officer Stockholm, April 11, 2012 – InDex Pharmaceuticals today announced two additions…

Personalized treatment option for patients with refractory ulcerative colitis Stockholm, March 20, 2012 – InDex Pharmaceuticals today announced the development of a companion diagnostic test for…

TLR9 Agonist for the Treatment of Chronic, Active, Treatment-Refractory Ulcerative Colitis Stockholm, March 6, 2012 – InDex Pharmaceuticals today announced the start of the COLLECT trial, a European…

Jesper Wiklund has been appointed Chief Executive Officer of InDex Pharmaceuticals AB (InDex) as of September 1st, 2011. He will bring 17 years of international commercial experience in the…

Industrifonden invests MSEK 40 and becomes a new shareholder in InDex
Pharmaceuticals, which develops Kappaproct – a drug for treatment of severe
inflammatory bowel disease. Current shareholders, including SEB Venture Capital,
invest an additional MSEK 35. The financing will in large be used to conduct a clinical
phase III trial using Kappaproct with the aim of obtaining market approval.

Stockholms läns landsting has as the first health care district in Sweden decided to
introduce DiBiCol on the list of reimbursed diagnostic tests. Approximately 15 000 out of a 1.5 million…

InDex Pharmaceuticals today announced that the first patent concerning the diagnostic test DiBiCol has been granted in Japan. With DiBiCol, the new and unique PCR-based test, inflammatory bowel…

Efficacy Demonstrated One Week after Single Dose Treatment The Swedish biopharmaceutical company InDex Pharmaceuticals AB today announced it has successfully concluded a clinical phase II proof of…

InDex Pharmaceuticals today announced that the last patient has now been recruited to
its clinical Phase II study of Kappaproct, for treating steroid resistant/dependent patients
with ulcerative…

InDex Pharmaceuticals has filed five more patents that will further strengthen its
extensive portfolio of proprietary intellectual assets. “We have complemented our IP assets with some important…