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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

InDex Pharmaceuticals announces that all patients needed for the cobitolimod dose selection milestone have completed Induction Study 1 of the phase III program CONCLUDE

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.“We are pleased to announce that the final patient visit needed for the dose selection analysis has occurred. We have seen great progress in the study and an accelerated patient

InDex Pharmaceuticals is attending the UEGW 2023 congress

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.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

”Positive results from PK study with cobitolimod” selected as one of the best abstracts for poster presentation at UEGW

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.“We are very pleased that our presentation of the PK study results was selected as one of the best

InDex Pharmaceuticals announces positive results from a pharmacokinetic (PK) study with cobitolimod

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.“One of the potential benefits of a locally acting treatment in the colon is low systemic exposure. We are therefore excited that the study has confirmed this benefit

InDex Pharmaceuticals provides complementary information on the phase III program CONCLUDE with cobitolimod

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.The presentation highlights the phase III study design, the cobitolimod dose selection, provides clarification and transparency of site and patient recruitment, reviews actions taken to facilitate patient recruitment and finally touches upon study economics. The presentation was organised by Redeye AB and the recording can be found on InDex’s web site, https://

InDex Pharmaceuticals updates the timeline of the phase III study CONCLUDE with cobitolimod

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.“Patient recruitment for the global phase III study CONCLUDE is under way. However, as previously communicated, lingering post-pandemic effects, Russia’s invasion of Ukraine

InDex Pharmaceuticals to exhibit at Digestive Disease Week

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.InDex Pharmaceuticals will be located at booth #1413 in the exhibition hall, San Diego Convention Centre. InDex’s team members will be present on site to provide information about cobitolimod and the ongoing phase III clinical study CONCLUDE,

InDex Pharmaceuticals enrols first patient in the PK study with cobitolimod

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.“Having recently treated the first patient in the pivotal phase III study CONCLUDE, I am very pleased to also announce that the first patient has been treated in the PK study with cobitolimod,” said Peter Zerhouni, CEO of InDex Pharmaceuticals. “With the PK study, we aim to confirm the limited

InDex Pharmaceuticals enrols first patient in the phase III study CONCLUDE with cobitolimod in ulcerative colitis

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.“I am thrilled to announce the enrolment of the first patient in the pivotal CONCLUDE study, which is an important milestone in bringing cobitolimod to the market for patients suffering from this debilitating disease,” said Peter Zerhouni, CEO of InDex

InDex Pharmaceuticals Holding AB (publ) interim report January – September 2021

Ready to initiate patient recruitment in phase III study CONCLUDE”We have now several clinics activated in the phase III study CONCLUDE and look forward to enrol the first patient in the near term”, says Peter Zerhouni, CEO of InDex Pharmaceuticals. ”It was quite dramatic in September when the FDA updated their safety warnings for JAK inhibitors as a class. It is a reminder that a product’s safety profile is very important.” Period July – September 2021 · Net sales amounted to SEK 0.0 (0.0) million · Operating loss amounted to SEK –28.2 (–7.7) million · Result after tax

InDex Pharmaceuticals will initiate patient recruitment for the Phase III study CONCLUDE after the summer

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.“The Covid-19 pandemic continues to affect significantly healthcare systems and regulatory authorities around the world, but the pressure is now decreasing in many countries. We therefore plan to initiate patient recruitment for the phase III study with cobitolimod on a

InDex Pharmaceuticals to present the successful results of the CONDUCT study at two leading medical conferences

August 24, 2020 – InDex Pharmaceuticals Holding AB (publ) today announced that the results of the CONDUCT study will be presented orally at two leading gastroenterology conferences; the United European Gastroenterology Week (UEGW) and the American College of Gastroenterology (ACG) Annual Scientific Meeting. CONDUCT was a phase IIb dose optimisation study, evaluating the first-in-class TLR9 agonist cobitolimod for the treatment of moderate to severe ulcerative colitis. The study met the primary endpoint with an outstanding combination of efficacy and safety.“We are very pleased that the

InDex Pharmaceuticals’ in-depth analysis of the CONDUCT study confirms the successful top line results and supports the strategy going forward

February 19, 2020 – InDex Pharmaceuticals Holding AB (publ) today announced the conclusions from in-depth analysis of the complete data set from the phase IIb dose optimisation study CONDUCT, evaluating the first-in-class TLR9 agonist cobitolimod for the treatment of moderate to severe ulcerative colitis. The analysis confirms that the highest dose tested, which met the primary endpoint of the study, demonstrates an outstanding combination of efficacy and safety.In-depth analysis of the complete data set has now been concluded and hence the Clinical Study Report can be finalised. As

InDex Pharmaceuticals publishes post-hoc analysis of the COLLECT study

October 19, 2018 – InDex Pharmaceuticals Holding AB (publ) today announced the publication of a post-hoc analysis of COLLECT study data. COLLECT was a clinical study of the Toll-like receptor 9 (TLR9) agonist cobitolimod, a first-in-class treatment for patients with moderate to severe ulcerative colitis (UC). The paper, published in the October issue of the peer-reviewed journal Digestive and Liver Disease (DLD), presents the clinical effect of cobitolimod on patient-reported outcomes (PRO) defined endpoints and in different patient subgroups defined by disease activity or anti-TNFα therapy

InDex Pharmaceuticals concludes well attended Investigators’ Meeting for the phase IIb study CONDUCT

March 22, 2017 – InDex Pharmaceuticals Holding AB (publ) today announced that the company hosted a well attended investigators’ meeting for the CONDUCT study on March 20-21, 2017 in Stockholm. CONDUCT is a phase IIb dose optimisation study with the drug candidate cobitolimod for the treatment of moderate to severe active ulcerative colitis.The meeting gathered physicians, study nurses and study coordinators from 65 clinics in 11 countries together with personnel from InDex and the contract research organization (CRO) PAREXEL. A total of almost 170 attendees participated in the meeting which

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