A three-part, double-blind, placebo-controlled, Phase I/Ib study of the safety, tolerability and pharmacokinetics of single and multiple ascending doses of IMU-856 in healthy volunteers and patients with with Celiac disease.

开始日期2022-07-07

申办/合作机构

Avance Clinical Pty Ltd.

100 项与 IMU-856 相关的临床结果

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100 项与 IMU-856 相关的转化医学

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100 项与 IMU-856 相关的专利（医药）

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项与 IMU-856 相关的文献（医药）

2026-04-01·GUT

Coeliac disease and the intestinal barrier: mechanisms of disruption and strategies for restoration

Review

作者: Damianos, John A ; Camilleri, Michael ; Bledsoe, Adam ; Murray, Joseph A

Coeliac disease is characterised by immune-mediated damage to the small intestine in response to dietary gluten in genetically predisposed individuals. Increased intestinal permeability is a central component to its pathophysiology. This review explores the evidence for increased permeability in coeliac disease and the underlying mechanisms, including the roles of zonulin, inflammatory cytokines, microbial alterations and immune responses to gliadin peptides. We also review comprehensively the therapies targeting barrier integrity and normalising intestinal permeability, including particular diets and supplements, and experimental and improved medications including larazotide acetate and IMU-856. Finally, we highlight the need for reliable biomarkers for evaluating increased permeability in coeliac disease and advocate for further research on therapies which normalise barrier function, particularly as a strategy to maintain remission.

2025-01-01·The Lancet Gastroenterology & Hepatology

Safety, clinical activity, pharmacodynamics, and pharmacokinetics of IMU-856, a SIRT6 modulator, in coeliac disease: a first-in-human, randomised, double-blind, placebo-controlled, phase 1 trial

Article

作者: Kohlhof, Hella ; Claudette Lionnet ; Stubbs, Richard ; Jelena Mihajlović ; Mark Schoeman ; Peelen, Evelyn ; Andreas Muehler ; Robert Anderson ; Tye-Din, Jason A ; Lionnet, Claudette ; Schreieck, Amelie ; Jorma Isola ; Jason A Tye-Din ; Mihajlović, Jelena ; Schoeman, Mark ; Muehler, Andreas ; Evelyn Peelen ; Polasek, Thomas M ; Richard Stubbs ; Wirth, Martina ; Daveson, A James M ; Hella Kohlhof ; Swee Lin Chen Yi Mei ; Martina Wirth ; Franziska Buriánek ; Vitt, Daniel ; A James M Daveson ; Isola, Jorma ; Thomas M Polasek ; Anderson, Robert ; Amelie Schreieck ; Mei, Swee Lin Chen Yi ; Buriánek, Franziska ; Daniel Vitt

BACKGROUND:

IMU-856 is an orally available and systemically acting small molecule modulator of sirtuin 6 (SIRT6), a protein that serves as a transcriptional regulator of bowel epithelium regeneration. We aimed to evaluate the safety, clinical activity, pharmacodynamics, and pharmacokinetics of IMU-856 in healthy participants and in patients with coeliac disease.

METHODS:

This study reports the results from a completed first-in-human, three-part, double-blind, randomised, placebo-controlled, clinical trial of IMU-856 in healthy participants and patients with coeliac disease done in Australia and New Zealand. In part A, healthy participants were enrolled in six cohorts and randomly assigned (3:1) using a block randomisation algorithm to receive single ascending doses of IMU-856 ranging from 10 mg to 160 mg or matching placebo. Based on the results from part A, three doses were selected for part B to evaluate the safety, tolerability, and pharmacokinetics of IMU-856 once daily for 14 days using the same randomisation algorithm. Part C enrolled patients with well controlled coeliac disease. Participants were centrally randomised 1:1:1 using an interactive web response system to receive either low dose or high dose of IMU-856 or placebo once daily for 28 days that included a 15-day gluten challenge starting on day 14. The primary objective was safety and tolerability of IMU-856. Safety analyses were done on all patients who received at least one dose of the study drug. The trial is registered with the ANZCTR registry (ACTRN12620000901909).

FINDINGS:

Between July 27, 2020, and Oct 28, 2022, 71 healthy participants were enrolled in part A and B and assigned to either placebo (n=19) or IMU-856 (n=52). In part A and B, the IMU-856 doses were 10 mg (n=6), 20 mg (n=6), 40 mg (n=13), 80 mg (n=12), 120 mg (n=4), 160 mg (n=11). 43 patients with coeliac disease were enrolled in part C and assigned to either placebo (n=14), IMU-856 80 mg (n=14), or IMU-856 160 mg (n=15). Treatment-emergent adverse events (TEAEs) occurred in 24 (73%) of 33 participants in part A and 15 (79%) of 19 participants in part B receiving any dose of IMU-856 compared with six (50%) of 12 participants in part A and five (71%) of seven participants in part B with placebo. TEAEs were mainly mild in severity. In part C, TEAEs occured in 26 (90%) of 29 patients on any dose of IMU-856 and ten (71%) of 14 receiving placebo; the most common TEAEs with any dose of IMU-856 by preferred term were headache (13 [45%] of 29), nausea (nine [31%]), diarrhoea (eight [28%]), and abdominal distension (seven [24%]). Two serious adverse events occurred with IMU-856 treatment (one in part B [bacterial myocarditis] and one in part C [biliary colic]), both of which were unrelated to IMU-856. No dose-limiting toxicities, systematic safety laboratory changes, or deaths occurred during the study. In part C, mean decrease in villous height was -20·9 μm (SD 34·8) among patients who received IMU-856 80 mg, -22·5 μm (51·1) among those who received IMU-856 160 mg, and -60·3 μm (52·2) among those who received placebo.

INTERPRETATION:

The favourable safety profile, along with preliminary activity, suggests that IMU-856 should be studied in future trials of coeliac disease.

FUNDING:

Immunic Australia.

Nutrients

Is There a Future Without Gluten Restrictions for Celiac Patients? Update on Current Treatments

Review

作者: Girbal-González, Marina ; Pérez-Cano, Francisco J.

Celiac disease (CeD) is a chronic autoimmune enteropathy triggered by dietary gluten in genetically predisposed individuals. Along with other disorders such as non-celiac gluten/wheat sensitivity and gluten allergy, adherence to a strict gluten-free diet (GFD) is required as the only effective treatment for CeD. To this end, and partially due to the burdensome nature and limited efficacy in some patients of a GFD, significant research into alternative therapies has been catalyzed. This review gives a perspective on current and emerging treatment strategies targeting different aspects of CeD pathogenesis. These include gluten-degrading enzymes (e.g., AN-PEP, Latiglutenase, Zamaglutenase), gluten-sequestering agents (e.g., AGY-010, BL-7010), modulators of intestinal permeability (e.g., Larazotide acetate, IMU-856), immune-modulating agents (e.g., ZED1227, AMG 714, EQ102), and strategies for immune tolerization (e.g., TAK-101, KAN-101, Nexvax2). Newer approaches are also targeting probiotics to modulate the gut microbiota (e.g., VSL#3, Lactobacillus plantarum HEAL9), nutraceuticals (e.g., polyphenols, vitamins), or food modifications to remove the gluten from naturally gluten-containing foodstuffs (e.g., gluten transamidation, Gluten Friendly™ technology). Despite encouraging results in preclinical and clinical trials, no treatment has yet been conclusively proven to serve as an effective alternative to the GFD. Continued research is essential to validate efficacy, optimize dosing, and ensure safety in broader patient populations. Here, we provide a comprehensive overview of the therapeutic landscape for CeD, analyze the main strengths and limitations of each treatment and highlight promising directions for future management of CeD, altogether evidencing the urgent need to develop effective alternatives for these patients.

130

项与 IMU-856 相关的新闻（医药）

2026-06-01

·IVD体外诊断网

罗氏高管，跳槽去大医企当CEO！

来源：Immunic Therapeutics 5月27日，据Immunic Therapeutics发布：罗氏旗下基因泰克资深高管Erik Lundgren 将成为首席执行官，自 2026 年 5 月 22 日起生效，其聘用关系自 2026 年 6 月 1 日开始。Lundgren 先生将接替 Daniel Vitt 博士，Vitt 博士将继续负责科学战略与产品线推进，并留任 Immunic 董事会成员。 Erik Lundgren拥有近二十年的生物制药经验，涵盖商业战略、产品上市、全球产品组合领导、市场营销和综合管理，尤其在 MS 领域具有深厚专长。他曾担任 Genentech（罗氏旗下基因泰克公司）商业产品组合组织高级副总裁，领导并监督公司广泛产品组合中所有治疗领域的商业战略。在此职位之前，他担任 Roche Czech Republic 总经理，负责全面运营和商业战略。更早之前，他曾在罗氏神经科学产品组合中担任亨廷顿病的生命周期负责人。 Erik Lundgren在 Genentech 工作十余年，担任的职责包括担任高级营销总监，支持 Ocrevus® (ocrelizumab) 的上市和商业化，该药是 RMS 和 PPMS 的基础治疗药物，也是神经科学领域最成功的上市产品之一。他还曾担任商业领导职务，支持包括 Kadcyla® (ado-trastuzumab emtansine) 和 Zelboraf® (vemurafenib) 在内的肿瘤药物的上市，并领导了 Genentech 肿瘤业务部门的多个销售团队。 Immunic, Inc.是一家生物技术公司，致力于开发治疗神经系统疾病的新型口服疗法。公司的主要开发项目 vidofludimus calcium (IMU-838) 目前正在进行治疗复发型多发性硬化症的 3 期临床试验，预计将于 2026 年底获得主要数据。该药物已在复发缓解型多发性硬化症、进展型多发性硬化症及其他疾病的 2 期临床试验中显示出治疗活性。Vidofludimus calcium 通过其作为 first-in-class 核受体相关因子 1 (Nurr1) 激活剂的机制发挥神经保护作用，同时通过选择性抑制二氢乳清酸脱氢酶 (DHODH) 提供额外的抗炎和抗病毒效果。公司的研发管线还包括更早期项目，如 IMU-856 和 IMU-381，旨在构建一个更广泛的治疗平台，用于解决神经退行性、慢性炎症和自身免疫相关疾病。声明：本微信注明来源的稿件均为转载，仅用于分享，不代表平台立场，如涉及版权等问题，请尽快联系我们，我们第一时间更正，谢谢！

2026-05-31

·PRNewswire

Immunic to Present Additional Phase 2 CALLIPER Trial Data for Vidofludimus Calcium at the CMSC Annual Meeting 2026, Reinforcing Its Potential in Progressive Multiple Sclerosis

– Late-Breaking Poster Introduces New Unified Statistical Analyses for Assessing Confirmed Disability Changes for Trials in Progressive Multiple Sclerosis – – Additional CALLIPER Data Further Highlight Vidofludimus Calcium's Favorable Safety and Tolerability Profile; Patient-Reported Outcomes Assessments Show No Negative Impact on Mood – May 28, 2026 --Immunic , Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases, today announced the presentation of one late-breaking and two additional posters highlighting additional data from its phase 2 CALLIPER trial evaluating lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838) in patients with progressive multiple sclerosis (PMS) at the 2026 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, taking place May 27-29, 2026 in Charlotte, NC. All poster presentations will be accessible on the "Events and Presentations" section of Immunic's website at: https://ir.imux.com/events-and-presentations. Additionally, Immunic team members will be available throughout the meeting at booth #307. "We believe the new data presented in these three posters at the prestigious CMSC Annual Meeting continues to demonstrate a consistent and differentiated profile for vidofludimus calcium in multiple sclerosis (MS)," stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "The late-breaking analysis is particularly interesting, as it introduces a new and potentially more comprehensive way to measure overall disability change by capturing both slowing of progression and improvement of disease. Together with supportive safety, tolerability and patient-reported data, these findings further strengthen our confidence in the potential of vidofludimus calcium to address key drivers of MS disease progression." "These post-hoc analyses from the phase 2 CALLIPER trial provide valuable insights as to the effects of vidofludimus calcium in patients with progressive MS," added Michael A. Panzara, M.D., M.P.H., Chief Medical Officer of Immunic. "Whereas disability in MS is commonly measured by 3- or 6-months confirmed disability worsening, our late-breaking poster presents a novel approach capturing both worsening and improvement on treatment, allowing for a more comprehensive assessment of well-being. In applying these assessments, we observed favorable effects of vidofludimus calcium versus placebo. These data, combined with a safety and tolerability profile that appears favorable, supports the continued development of vidofludimus calcium for progressive MS." Late-Breaking Poster Presentation Details: Poster Title: Novel Unified Statistical Analyses for Confirmed Disability Changes in Multiple Sclerosis for Capturing Possible Neuroprotective Effects Presenting Author: James Myles, Global Head of Biostatistics at Immunic Abstract ID: 11244 Poster Board Label: LBA14 Session Date: Thursday, May 28, 2026 Session Time: 5:00-7:00 pm ET Location: Exhibit Hall This late-breaking poster introduces a novel unified endpoint, Confirmed Disability Change (CDC), designed to capture both confirmed disability worsening (CDW) and confirmed disability improvement (CDI) within a single statistical framework. Three complementary statistical approaches, including ordinal categorical analysis, time-to-event modeling and Markov state change modeling, were applied post-hoc to data from the phase 2 CALLIPER trial in PMS. Across these models, results consistently favored vidofludimus calcium over placebo. These findings suggest that the CDC approach may provide a more complete view of disability trajectories in PMS than conventional one-direction analyses, particularly for evaluating possible neuroprotective effects. Broader adoption of such an integrated endpoint may improve statistical power in future clinical trials and help better capture treatment benefits for patients with PMS. Poster Presentation Details: Poster Title: Effect of Vidofludimus Calcium, a Direct Nurr1 Activator and Selective DHODH Inhibitor, on Patient-Reported Outcomes (PRO) in Progressive MS: Data from Phase 2 CALLIPER Trial Presenting Author: Julie Korich, Ph.D., Senior Medical Director, Medical Affairs at Immunic Abstract ID: 10843 Poster Board Label: DMT10 Session Date: Thursday, May 28, 2026 Session Time: 5:00-7:00 pm ET Location: Exhibit Hall B This poster presents patient-reported outcomes from the phase 2 CALLIPER trial of vidofludimus calcium in PMS, including measures of severity of depressive thoughts (Patient Health Questionnaire-9, PHQ-9) and overall treatment satisfaction (Treatment Satisfaction Questionnaire for Medication), collected over the treatment period of up to 120 weeks. Analyses using a mixed model repeated measures (MMRM) approach showed that changes in PHQ-9 scores were similar between vidofludimus calcium and placebo across all assessed timepoints, including weeks 48, 72 and 120. At week 48, PHQ-9 scores numerically improved in both groups (vidofludimus calcium: -0.786 vs. placebo: -0.347), with a similar pattern observed at week 72 (vidofludimus calcium: -0.568 vs. placebo: -0.609) and week 120 (vidofludimus calcium: -1.777 vs. placebo: -0.525). There was no indication of worsening depressive or suicidal thoughts with vidofludimus calcium (n=235) as compared to placebo (n=232) through 120 weeks. Patient-reported treatment effectiveness numerically favored vidofludimus calcium over placebo, particularly in perceived effectiveness at both week 48 (77.51 vs. 72.88) and week 120 (84.69 vs. 79.20), while side effect burden remained comparable between the treatment groups at both timepoints (97.65 vs. 97.70 at week 48 and 99.44 vs. 99.36 at week 120). Although exploratory in nature, these findings support a favorable patient-reported profile for vidofludimus calcium over two years. Presentation Details: Poster Title: Safety and Tolerability of Vidofludimus Calcium, a Direct Nurr1 Activator and Selective DHODH Inhibitor: Data from Phase 2 CALLIPER Trial Presenting Author: Alex Lublin, Ph.D., Senior Medical Director, Medical Affairs at Immunic Abstract ID: 10995 Poster Board Label: DMT11 Session Date: Thursday, May 28, 2026 Session Time: 5:00-7:00 pm ET Location: Exhibit Hall B This poster provides an overview of safety and tolerability data from the phase 2 CALLIPER trial of vidofludimus calcium in PMS, based on 467 patients treated for up to 120 weeks. The overall incidence of treatment-emergent adverse events (TEAEs) was comparable between vidofludimus calcium (69.4%) and placebo (68.5%). The most commonly reported events, including urinary tract infection, headache and back pain, occurred at similar or lower rates in the vidofludimus calcium arm compared to placebo. TEAEs leading to discontinuation were identical at 2.6% in both groups. Liver-related TEAEs were uncommon and similar between vidofludimus calcium and placebo (5.2% vs. 5.5%), with no cases meeting Hy's law criteria. Serious adverse events were observed at low and comparable rates between groups (8.1% vs. 6.5%). Rates of infections and infestations as well as renal or urinary events were also similar between groups. The collective data set shows a similar overall adverse events profile between vidofludimus calcium and placebo. These results are consistent with previous clinical experience and support the favorable safety and tolerability profile of vidofludimus calcium in patients with PMS. Vidofludimus calcium is an orally administered investigational small molecule drug, currently in late-stage clinical trials for multiple sclerosis (MS). Vidofludimus calcium has a unique mode of action designed to combine neuroprotective, anti-inflammatory and anti-viral effects to address key biological drivers of MS. As a selective immune modulator, it activates the neuroprotective transcription factor nuclear receptor-related 1 (Nurr1), which has been associated with direct and indirect neuroprotective effects. Additionally, vidofludimus calcium is a highly selective inhibitor of the enzyme dihydroorotate dehydrogenase (DHODH), which has been associated with anti-inflammatory and anti-viral effects. Vidofludimus calcium is currently being evaluated in the phase 3 ENSURE trials for the treatment of relapsing MS. In the phase 2 EMPhASIS trial, it showed therapeutic activity in relapsing-remitting MS patients, significantly reducing brain lesions and demonstrating encouraging results in reducing confirmed disability worsening. In the phase 2 CALLIPER trial in progressive MS patients, vidofludimus calcium showed promising clinical signals, including reductions in confirmed disability progression and statistically significant confirmed disability improvement. To date, more than 3,400 individuals have been exposed to vidofludimus calcium and it has shown a favorable pharmacokinetic, safety and tolerability profile. Vidofludimus calcium is not yet licensed or approved in any country and its efficacy, safety and tolerability are still being evaluated in ongoing clinical trials. Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). The company's development pipeline also includes earlier-stage programs, including IMU-856 and IMU-381, aimed at building a broader therapeutics platform addressing neurodegenerative, chronic inflammatory, and autoimmune-related diseases. 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临床结果

2026-05-31

·体外诊断网

罗氏老将，上任大医企CEO！

来源：Immunic Therapeutics 整理：体外诊断网 5月27日，据Immunic Therapeutics发布：罗氏旗下基因泰克资深高管Erik Lundgren 将成为首席执行官，自 2026 年 5 月 22 日起生效，其聘用关系自 2026 年 6 月 1 日开始。Lundgren 先生将接替 Daniel Vitt 博士，Vitt 博士将继续负责科学战略与产品线推进，并留任 Immunic 董事会成员。 Erik Lundgren拥有近二十年的生物制药经验，涵盖商业战略、产品上市、全球产品组合领导、市场营销和综合管理，尤其在 MS 领域具有深厚专长。他曾担任 Genentech（罗氏旗下基因泰克公司）商业产品组合组织高级副总裁，领导并监督公司广泛产品组合中所有治疗领域的商业战略。在此职位之前，他担任 Roche Czech Republic 总经理，负责全面运营和商业战略。更早之前，他曾在罗氏神经科学产品组合中担任亨廷顿病的生命周期负责人。 Erik Lundgren在 Genentech 工作十余年，担任的职责包括担任高级营销总监，支持 Ocrevus® (ocrelizumab) 的上市和商业化，该药是 RMS 和 PPMS 的基础治疗药物，也是神经科学领域最成功的上市产品之一。他还曾担任商业领导职务，支持包括 Kadcyla® (ado-trastuzumab emtansine) 和 Zelboraf® (vemurafenib) 在内的肿瘤药物的上市，并领导了 Genentech 肿瘤业务部门的多个销售团队。 Immunic, Inc.是一家生物技术公司，致力于开发治疗神经系统疾病的新型口服疗法。公司的主要开发项目 vidofludimus calcium (IMU-838) 目前正在进行治疗复发型多发性硬化症的 3 期临床试验，预计将于 2026 年底获得主要数据。该药物已在复发缓解型多发性硬化症、进展型多发性硬化症及其他疾病的 2 期临床试验中显示出治疗活性。Vidofludimus calcium 通过其作为 first-in-class 核受体相关因子 1 (Nurr1) 激活剂的机制发挥神经保护作用，同时通过选择性抑制二氢乳清酸脱氢酶 (DHODH) 提供额外的抗炎和抗病毒效果。公司的研发管线还包括更早期项目，如 IMU-856 和 IMU-381，旨在构建一个更广泛的治疗平台，用于解决神经退行性、慢性炎症和自身免疫相关疾病。声明：本文仅用于分享，不代表平台立场，如有侵权或涉及版权问题，请尽快联系我们，我们第一时间更正，谢谢！为了方便体外诊断网的读者粉丝朋友们沟通交流，我们特成立体外诊断网全国第209群！欢迎大家扫描下方二维码，入群踊跃发言！直播预约 ▼ 热点视频推荐 ▼ 检验人声小程序 ▼

100 项与 IMU-856 相关的药物交易

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