相关临床试验
0
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2016
暂无试验阶段数据
暂无试验数据
暂无试验数据
暂无批准数据
- Immunic, Inc. has appointed Chitrang Davé as its newly created Chief Data and Digital Officer, effective September 1, 2026, reporting directly to CEO Erik Lundgren. - The role will establish enterprise-wide data, analytics, AI, and digital capabilities to support the potential NDA submission and commercialization of vidofludimus calcium (IMU-838) in multiple sclerosis. - Top-line data from the Phase 3 ENSURE trials in relapsing MS are expected by year-end 2026, with a confirmatory Phase 3 program in progressive MS advancing. - Davé brings more than 25 years of data and analytics leadership experience from Avidity Biosciences, Edwards Lifesciences, and Medtronic.
- Immunic will present the discovery of IMU-856, a selective Sirtuin 6 modulator with novel binding characteristics for gastrointestinal disease, at the EFMC-ACSMEDI Medicinal Chemistry Frontiers 2026 Symposium in Dublin. - The company's lead candidate vidofludimus calcium (IMU-838) is in phase 3 trials for relapsing multiple sclerosis, with top-line data expected by the end of 2026. - Vidofludimus calcium is a first-in-class Nurr1 activator with neuroprotective effects and additional anti-inflammatory and antiviral activity through selective DHODH inhibition. - Immunic's pipeline also includes IMU-381, targeting neurodegenerative, chronic inflammatory, and autoimmune-related diseases as part of a broader therapeutics platform.
- Immunic secured an oversubscribed $400 million private placement led by BVF Partners to transition from R&D-focused to commercial-stage operations. - The funding will complete Phase III ENSURE studies of vidofludimus calcium in relapsing multiple sclerosis, with top-line results expected by year-end. - Vidofludimus calcium represents a first-in-class therapy targeting both neuroprotection via Nurr1 activation and inflammation reduction through selective DHODH inhibition. - The company plans to submit a US new drug application by mid-2027 and launch a Phase III program in primary progressive multiple sclerosis later this year.
- Immunic has completed enrollment for both Phase 3 ENSURE trials of vidofludimus calcium in relapsing multiple sclerosis, with 2,221 patients randomized across 15 countries and top-line data expected by end of 2026. - Phase 2 CALLIPER data demonstrated that vidofludimus calcium reduced 24-week confirmed disability worsening and increased disability improvement across progressive multiple sclerosis subtypes, supporting its neuroprotective mechanism. - Long-term open-label extension data from the Phase 2 EMPhASIS trial showed 92.3% of patients remained free of confirmed disability worsening at week 144, with favorable safety profile maintained up to 5.5 years. - The company received U.S. patent protection for vidofludimus calcium dose strengths in progressive multiple sclerosis, extending intellectual property protection until 2041.
- Immunic received a Notice of Allowance from the USPTO for its fifth US patent covering vidofludimus calcium dose strengths of 10-45 mg daily for progressive multiple sclerosis treatment. - The patent provides protection until 2041 with potential for extension, strengthening the company's comprehensive intellectual property portfolio for both primary and secondary progressive MS. - The patent approval follows positive phase 2 CALLIPER trial data showing vidofludimus calcium delayed confirmed disability worsening and reduced brain volume loss in progressive MS patients. - Vidofludimus calcium operates through a first-in-class dual mechanism combining neuroprotective effects via Nurr1 activation with anti-inflammatory properties through DHODH inhibition.
- IMU-856, an oral SIRT6 modulator, demonstrated significant dose-dependent increases in GLP-1 levels up to 250% versus placebo in celiac disease patients during Phase 1b trial. - Preclinical studies revealed IMU-856 reduced body weight gain and food consumption by up to 40% compared to control groups, suggesting potential applications in weight management. - The drug's unique mechanism targeting SIRT6 may offer a broader activation of enteroendocrine hormones, positioning it as a potential oral alternative to injectable incretin therapies.
- Immunic's phase 2 CALLIPER trial of Vidofludimus Calcium in progressive multiple sclerosis is expected to report top-line data in April. - Interim analysis of the phase 3 ENSURE trials for relapsing multiple sclerosis showed positive outcomes, with completion expected in 2026. - Vidofludimus Calcium targets Nurr1 activation for neuroprotection and DHODH inhibition for anti-inflammatory and antiviral effects in MS.
- The multiple sclerosis (MS) therapeutic landscape is expanding, with over 80 active pipeline therapies currently in development by more than 75 companies. - Recent clinical trials have yielded mixed results, with some therapies showing promise in specific MS subtypes, such as non-relapsing secondary progressive MS (nrSPMS). - Regulatory milestones have been achieved, including FDA approval for new formulations and fast-track designations for therapies targeting progressive MS. - Emerging therapies in the MS pipeline include monoclonal antibodies, oral treatments, and CAR-T cell therapies, offering diverse mechanisms of action and routes of administration.
- Immunic's IMU-856, a SIRT6 modulator, demonstrated positive clinical signals in a Phase 1/1b trial for celiac disease, showing potential in restoring gut health. - The trial highlighted improvements in gut architecture, patient symptoms, biomarker responses, and nutrient absorption, suggesting a novel approach to treating celiac disease. - IMU-856 was found to be safe and well-tolerated, with no serious adverse events reported, supporting its potential as a first-in-class oral therapy. - The data provides initial clinical proof-of-concept for a new therapeutic approach to various gastrointestinal diseases with high unmet needs, beyond celiac disease.
- Immunic's Phase 3 ENSURE program for relapsing multiple sclerosis (RMS) continues as planned after a positive interim analysis by the Independent Data Monitoring Committee. - Top-line data from the Phase 2 CALLIPER trial of vidofludimus calcium in progressive multiple sclerosis (PMS) is expected in April 2025. - Vidofludimus calcium's neuroprotective, anti-inflammatory, and anti-viral effects could position it as a unique treatment option for multiple sclerosis. - Immunic is preparing for Phase 2 testing of IMU-856 in celiac disease, contingent on securing financing, licensing, or a partnering agreement.
