Kappaproct (cobitolimod) / InDex Pharma, Viatris - LARVOL DELTA

Comparative Efficacy of Different Targeted Therapies in Patients With Moderate-to-Severe Ulcerative Colitis: Systematic Review/Network Meta-Analysis and Mechanistic Overview. (PubMed, Pharmacol Res Perspect) - "Cobitolimod 250 mg was the first-ranked treatment (SUCRA, 92.67%) in Endoscopic remission. Vedolizumab 108 mg was the best dosage in reducing Adverse Events (AEs). The optimal dosage for reducing Serious Adverse Events (SAEs) was found to be Tulisokibart 1000/500 mg. During the maintenance phase, Etrasimod 2 mg/kg ranked first in clinical remission (OR 9.58; 95% CI, 2.82-32.59), and Upadacitinib 45 mg was superior in endoscopic remission. Additionally, the most effective medication for raising quality of life was Guselkumab 200 mg (OR 3.04; 95% CI, 1.70-5.40). Consequently, there is a need for further high-quality research to conclusively determine the best therapeutic option."

Clinical • Journal • Retrospective data • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Kappaproct: Patent protection in EU related to formulation until Sep 2042 (InDex) - Annual Report 2023

Patent • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

InDex Pharmaceuticals provides an update on company’s future (InDex Press Release) - "InDex Pharmaceuticals Holding AB...announces that, in light of today’s separate press release, with the announcement that the development of cobitolimod is discontinued, the company is evaluating other alternatives to maximize shareholder value. Alternatives such as merger and reverse merger are weighed against company liquidation. InDex Pharmaceuticals will not proceed with development of any of its other compounds."

Discontinued • CNS Disorders • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

InDex Pharmaceuticals discontinues the development of cobitolimod (InDex Press Release) - P3 | N=171 | CONCLUDE (NCT04985968) | Sponsor: InDex Pharmaceuticals | "InDex Pharmaceuticals Holding AB...announced that the company will discontinue development of their drug candidate cobitolimod. Thorough analysis of the data from Induction Study 1 of the phase III program CONCLUDE has not provided any results justifying continued development....The primary endpoint, clinical remission at week 6 was achieved by 4.9% (2 out of 41) of the patients in the 250 mg cobitolimod group and by 6.8% (3 out of 44) of the patients in the 500 mg cobitolimod group, compared to 6.7% (3 out of 45) of the patients in the placebo group."

P3 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

InDex Pharmaceuticals announces expected cash balance per March 31, 2024 (PRNewswire) - "InDex Pharmaceuticals Holding AB...announced that remaining commitments for the company have been quantified, and the expected cash balance per March 31, 2024, amounts to SEK 180-190 million. The amount includes all closing costs for the phase III program CONCLUDE, even though activities for closing the phase III program will continue also after March 31, 2024....The concluding results from the terminated Induction Study 1 of the phase III program CONCLUDE are expected in the latter part of February 2024 and will be communicated at that timepoint."

Commercial • P3 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

CONCLUDE: The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis (clinicaltrials.gov) - P3 | N=171 | Terminated | Sponsor: InDex Pharmaceuticals | N=440 ➔ 171 | Trial completion date: Dec 2024 ➔ Dec 2023 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2024 ➔ Dec 2023; Due to futility

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

InDex Pharmaceuticals discontinues cobitolimod phase III program (PRNewswire) - "InDex Pharmaceuticals Holding AB...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....The pre-specified and independent analysis included the first 133 patients (i.e., approximately 30% of the total 440 patient enrollment in Induction Study 1) who had completed the 6-week induction study. As part of the analysis, the DMC performed a safety review and a futility assessment based on the primary endpoint clinical remission at week 6."

DSMB • Trial termination • Ulcerative Colitis

InDex Pharmaceuticals has been granted a new patent for cobitolimod in South Korea (PRNewswire) - "InDex Pharmaceuticals Holding...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. The patent (patent number: 10-2592716) will provide an exclusivity period until August 2040, with the possibility of up to 5 years patent term extension upon market approval. Corresponding patent applications have previously been granted in Europe and Hong Kong and filed in additional strategically important patent territories globally."

Patent • Inflammatory Bowel Disease

InDex Pharmaceuticals announces that all patients needed for the cobitolimod dose selection milestone have completed Induction Study 1 of the phase III program CONCLUDE (PRNewswire) - "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....Patient recruitment into Induction Study 1 continues throughout this analysis."

Enrollment status • P3 data • Trial status • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

InDex Pharmaceuticals is attending the UEGW 2023 congress (PRNewswire) - "InDex Pharmaceuticals Holding AB...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."

Clinical • P3 data • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

PHARMACOKINETICS OF RECTALLY ADMINISTERED COBITOLIMOD IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS: A PHASE IB OPEN-LABEL STUDY (UEGW 2023) - P1 | "The study demonstrates that rectally administered cobitolimod results in a low systemic exposure of short duration both in patients with active disease and in clinical remission. Cobitolimod was safe and well tolerated at a dose of 500 mg."

Clinical • P1 data • PK/PD data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

’Positive results from PK study with cobitolimod’ selected as one of the best abstracts for poster presentation at UEGW: InDex Pharmaceuticals (PRNewswire) - P1 | N=6 | NCT05404074 | Sponsor: InDex Pharmaceuticals | "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 systemic uptake of cobitolimod was limited both for patients with active disease and in clinical remission, with the majority of patients having undetectable levels of cobitolimod in the plasma after 8 hours. Even though it was a small-scale open-label study, it was encouraging that 4 out of 7 patients achieved clinical remission at week 6 after receiving two doses of 500 mg cobitolimod....InDex's team members will be available on site to provide information about cobitolimod and the ongoing phase III program CONCLUDE."

P1 data • PK/PD data • Trial status • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Emerging Therapies for Ulcerative Colitis: Updates from Recent Clinical Trials. (PubMed, Clin Exp Gastroenterol) - "This includes agents with alternative routes of administration such as oral or subcutaneous tumor necrosis factor inhibitors or novel mechanisms of action such as toll-like receptor 9 (TLR9) agonist cobitolimod and phosphodiesterase 4 inhibitor apremilast. In this review, we will highlight novel and emerging advanced therapies currently in the pipeline for the management of UC."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Oncology • Ulcerative Colitis

InDex Pharmaceuticals has been granted a new patent in Europe for the commercial formulation of cobitolimod (PRNewswire) - "InDex Pharmaceuticals Holding AB...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. The patent (European patent application number EP 22 785 698.6) will provide an exclusivity period until September 2042, with the possibility of up to 5 years extension upon market approval."

Patent • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

InDex Pharmaceuticals announces license agreement with Viatris Japan to develop and commercialize cobitolimod in Japan (PRNewswire) - "InDex Pharmaceuticals Holding AB...announced that a license agreement has been signed with Viatris Pharmaceutical 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. Under the terms of the agreement, Viatris Japan will pay InDex an upfront fee of USD 10 million for the exclusive rights to commercialize cobitolimod in Japan. In addition, InDex is eligible to receive development and sales milestone payments of up to USD 40 million. Viatris Japan will also pay up to double-digit percentage royalties based on its net sales for the product in Japan."

Licensing / partnership • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Welcome to an InDex Pharmaceuticals business update presentation in Stockholm on May 9, from 13:00 to 15.30 CET (PRNewswire) - "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."

Clinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

InDex Pharmaceuticals announces positive results from a pharmacokinetic (PK) study with cobitolimod (PRNewswire) - P=NA, N=7 | "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....The company plans to publish complete study results in a scientific journal and present them at an upcoming medical conference."

Clinical data • PK/PD data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

InDex Pharmaceuticals to attend the ECCO 2023 congress (PRNewswire) - "InDex Pharmaceuticals Holding AB...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....InDex Pharmaceuticals will also be present at booth #C3-17 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 1 study of the CONCLUDE program to discuss study progress with the coordinating Investigator Professor Raja Atreya."

Clinical • Trial status • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

InDex Pharmaceuticals provides complementary information on the phase III program CONCLUDE with cobitolimod (PRNewswire) - "InDex Pharmaceuticals Holding AB...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..."

Clinical protocol • Commercial • Enrollment status • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

InDex Pharmaceuticals updates the timeline of the phase III study CONCLUDE with cobitolimod (Market Screener) - "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 study will include approximately 440 patients and is conducted at several hundred clinics in over 30 countries in Europe, the Americas and the Asia-Pacific region."

Clinical • Enrollment status • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

InDex Pharmaceuticals Holding AB (publ) interim report January - September 2021 (PRNewswire) - "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. We are pushing hard to get more and more clinics ready to enrol patients as we receive regulatory approval to start the study in the respective countries. We have already approval in the US, Sweden, Hungary, and France, and expect approval in several more countries in the coming weeks....The study will be conducted at several hundred clinics in over 30 countries."

Trial status • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

InDex Pharmaceuticals to exhibit at United European Gastroenterology Week (PRNewswire) - "InDex Pharmaceuticals Holding AB...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....InDex's team members will be present on site to provide information about cobitolimod and the ongoing phase III clinical study CONCLUDE, evaluating the Toll-like receptor 9 agonist cobitolimod as a novel treatment for moderate to severe left-sided ulcerative colitis."

Clinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

CONCLUDE: The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis (clinicaltrials.gov) - P3 | N=440 | Recruiting | Sponsor: InDex Pharmaceuticals | Trial completion date: Aug 2023 ➔ Dec 2024 | Trial primary completion date: Aug 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

InDex Pharmaceuticals announces successful interactions with the PMDA for the clinical development of cobitolimod in Japan (PRNewswire) - "InDex Pharmaceuticals Holding AB...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."

New P3 trial • Inflammatory Bowel Disease • Ulcerative Colitis

InDex Pharmaceuticals gets new patent for cobitolimod granted in Europe (PRNewswire) - "InDex Pharmaceuticals Holding AB...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."

Patent • Inflammatory Bowel Disease