- |||||||||| Kappaproct (cobitolimod) / InDex Pharma, Viatris, cobitolimod oral / InDex Pharma
Review, Journal: Emerging Therapies for Ulcerative Colitis: Updates from Recent Clinical Trials. (Pubmed Central) - Aug 23, 2023 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.
- |||||||||| Clinical, Review, Journal: Review: emerging drug therapies in inflammatory bowel disease. (Pubmed Central) - Apr 22, 2022
Several new IBD drug therapies have positive efficacy and safety data in early clinical trials, and there are several drugs in the therapeutic pipeline. As more treatments for CD and UC are approved for clinical use, research to assess predictors of response to therapy and head-to-head trials is needed to inform providers on how to best position therapeutic options for patients with IBD.
- |||||||||| Kappaproct (cobitolimod) / InDex Pharma, Viatris
Trial completion: CONDUCT: The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis (clinicaltrials.gov) - Jan 31, 2021 P2, N=213, Completed, Activation of TLR9 via cobitolimod might represent a novel therapeutic approach in UC, as it suppresses Th17 cells and induces anti-inflammatory IL10+macrophages and regulatory T cells, thereby modifying the dysregulated intestinal cytokine balance. Active, not recruiting --> Completed
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Enrollment closed, Trial completion date, Trial primary completion date: CONDUCT: The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis (clinicaltrials.gov) - Aug 6, 2019 P2, N=213, Active, not recruiting, The concept of TLR9 activation is a promising novel therapeutic option in UC and is planned to be confirmed in an upcoming phase III program. Recruiting --> Active, not recruiting | Trial completion date: Jan 2019 --> Sep 2019 | Trial primary completion date: Dec 2018 --> Sep 2019
- |||||||||| Review, Journal: Oligonucleotides-A Novel Promising Therapeutic Option for IBD. (Pubmed Central) - May 10, 2019
...Alicaforsen, selectively targets ICAM-1 mRNA...An antisense oligonucleotide against SMAD7 mRNA (mongersen) demonstrated pre-clinical and phase II efficacy in CD, but a phase III clinical trial was stopped due to lack of efficacy...Topical application of cobitolimod was studied in UC patients. We will also discuss two other novel oligonucleotides which act on the GATA3 transcription factor (SB012) and on carbohydrate sulfotransferase 15 (STNM01), which could both represent novel promising therapeutic options for the treatment of UC.
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Trial completion: COLLECT: The Efficacy and Safety of Cobitolimod (Kappaproct (clinicaltrials.gov) - Jun 18, 2014 P3, N=131, Completed, Application of the Toll-like-receptor 9 (TLR-9) agonist cobitolimod is able to induce remission as assessed by PRO measures in UC patients with moderate-to-severe activity as well as in anti-TNFα experienced and naïve patients supporting the overall efficacy of the substance. Active, not recruiting --> Completed
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