Core Insights - Immunic Inc is focusing on addressing both physical and mental health challenges faced by multiple sclerosis (MS) patients, recognizing the strong link between MS and mental health issues such as depression and anxiety [1][2][3] Research Focus - The company emphasizes the importance of treating MS as more than just a neurological disease, highlighting that approximately 30% of MS patients experience depression and around 20% experience anxiety [2][3] - Immunic's research aims to slow disease progression, particularly focusing on progression independent of relapse activity (PIRA), which accounts for at least 50% of disability accumulation in relapsing-remitting MS [3][4] Treatment Development - Immunic is dedicated to addressing unmet needs in all forms of MS, especially for patients with primary progressive MS (PPMS), where over 50% experience depressive symptoms and treatment options are limited [4] - The company has reported positive data from its Phase 2 clinical trials, including the EMPhASIS trial and CALLIPER trial, which focus on the drug vidofludimus calcium [3][4] Vision for Future Treatment - The vision for future MS treatments includes a holistic approach that integrates mental health support into every stage of care, aiming for effective and tolerable treatments that improve patients' overall quality of life [5][6]

To ensure this doesn’t happen in the future, please enable Javascript and cookies in your browser.If you have an ad-blocker enabled you may be blocked from proceeding. Please disable your ad-blocker and refresh. ...

Core Viewpoint - Immunic, Inc. is actively participating in several scientific and investor conferences in October 2025 to present data on its clinical pipeline, particularly focusing on its orally administered therapies for chronic inflammatory and autoimmune diseases [1][2][3]. Conference Participation - Immunic's R&D team will present data on IMU-856 at the United European Gastroenterology Week (UEGW) in Berlin, Germany, from October 4-7, 2025, highlighting its positive effects on gut hormone levels in celiac disease patients [2]. - At the 17th International Congress of the International Society of Neuroimmunology (ISNI) in Chiba, Japan, from October 5-8, 2025, Immunic will present data on its lead asset, vidofludimus calcium (IMU-838), which exhibits signs of neuroprotection in preclinical models [2][3]. - Immunic's CEO and CFO will participate in the Roth's 4th Annual Healthcare Opportunities Conference in New York on October 9, 2025, discussing the next wave of innovation in underserved indications [2]. - A virtual fireside chat with Immunic's leadership will take place on October 23, 2025, as part of H.C. Wainwright's HCW @ Home event [2]. Clinical Development Programs - Vidofludimus calcium (IMU-838) is currently in phase 3 clinical trials for relapsing multiple sclerosis, with top-line data expected by the end of 2026. It has shown therapeutic activity in phase 2 trials for both relapsing-remitting and progressive multiple sclerosis [3]. - IMU-856 targets SIRT6 to restore intestinal barrier function and may be applicable in various gastrointestinal diseases, including celiac disease and inflammatory bowel disease [3]. - IMU-381, currently in preclinical testing, is a next-generation molecule aimed at addressing gastrointestinal disease needs [3].

An unheralded New York–listed biotech is chasing one of neurology’s biggest goals: a pill that not only tamps down the inflammatory flares of multiple sclerosis but also directly protects the brain from the slow, steady damage that leaves many patients disabled. Immunic Inc (NASDAQ:IMUX) is developing vidofludimus calcium, an oral medicine it says is “first-in-class” because it combines two mechanisms: one to reduce relapses and magnetic resonance imaging (MRI) lesions, and another aimed at shielding neuron ...

About this content About Ian Lyall Ian Lyall, a seasoned journalist and editor, brings over three decades of experience to his role as Managing Editor at Proactive. Overseeing Proactive's editorial and broadcast operations across six offices on three continents, Ian is responsible for quality control, editorial policy, and content production. He directs the creation of 50,000 pieces of real-time news, feature articles, and filmed interviews annually. Prior to Proactive, Ian helped lead the business outpu ...

Core Insights - Immunic, Inc. presented significant data on vidofludimus calcium at the ECTRIMS Congress, highlighting its potential to improve disability in progressive multiple sclerosis (PMS) patients [1][2] - The CALLIPER trial demonstrated a statistically significant reduction in confirmed disability worsening (24wCDW) and improvement (24wCDI) in the overall PMS population, with a notable two-fold probability over placebo [2][4] - Long-term data from the EMPhASIS trial showed high rates of patients remaining free of confirmed disability worsening, indicating favorable safety and tolerability [1][9] Group 1: CALLIPER Trial Findings - Vidofludimus calcium reduced the risk of 24wCDW by 23.8% in the overall PMS population and by 33.7% in patients without gadolinium-enhancing lesions [4][7] - The treatment demonstrated consistent trends in reducing disability progression across various outcomes and subgroups, supporting its neuroprotective potential [5][7] - The results from the CALLIPER trial were selected for the 'Best of ECTRIMS 2025' slide deck, underscoring their significance [2][10] Group 2: EMPhASIS Trial Insights - In the EMPhASIS trial, 92.3% of patients remained free of 12-week confirmed disability worsening (12wCDW) and 92.7% remained free of 24-week confirmed disability worsening (24wCDW) at week 144 [9][13] - The trial indicated low discontinuation rates and a favorable long-term safety profile, with no new safety signals observed [9][13] - Cumulative data from up to 5.5 years of treatment reinforced the drug's tolerability and safety [9][13] Group 3: Mechanism and Future Potential - Vidofludimus calcium acts as a Nurr1 activator, which may represent a novel mechanism to prevent neurodegeneration in MS [2][5] - The drug's unique dual mode of action combines neuroprotective, anti-inflammatory, and anti-viral effects, positioning it as a potential differentiated oral therapy in the multi-billion-dollar MS market [2][15] - The company is advancing vidofludimus calcium into phase 3 studies for PMS, with top-line data from ongoing trials expected by the end of 2026 [2][16]

Core Insights - The company is focused on the development of transcript-related projects, indicating a commitment to enhancing their offerings in this area [1] Group 1 - The company publishes thousands of quarterly earnings calls each quarter, showcasing significant growth and expansion in their coverage [1]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and improve content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Core Insights - Immunic, Inc. has received a Notice of Allowance for a new patent related to vidofludimus calcium, which is aimed at treating progressive multiple sclerosis (PMS) and is expected to provide protection until 2041, with potential extensions [1][2] Group 1: Patent and Intellectual Property - The newly allowed patent covers dose strengths of vidofludimus calcium ranging from 10 mg to 45 mg for treating PMS, including primary and secondary progressive forms [1] - Immunic's intellectual property strategy includes multiple granted patents in the U.S. and Europe, covering various aspects of vidofludimus calcium, including composition-of-matter and dosing regimens [2] - A pending application could extend patent protection for vidofludimus calcium up to 2044 if granted, with additional undisclosed applications in process to strengthen exclusivity [2] Group 2: Clinical Development and Efficacy - Vidofludimus calcium has shown neuroprotective potential in clinical trials, delaying confirmed disability worsening and reducing brain volume loss in patients with PMS [2][3] - The drug is currently in phase 3 clinical trials for relapsing multiple sclerosis, with top-line data expected by the end of 2026 [4] - To date, vidofludimus calcium has been tested in approximately 2,700 individuals, demonstrating a favorable pharmacokinetic, safety, and tolerability profile [3]

Summary of Immunic, Inc. Conference Call Company Overview - **Company Name**: Immunic, Inc. - **Ticker**: IMUX - **Industry**: Biotechnology - **Focus**: Developing small molecule therapies for chronic inflammatory and autoimmune diseases [1][2] Core Products - **IMU-856**: - Phase II-ready asset targeting SIRT6 to regenerate gut wall and barrier function in gastrointestinal diseases. - Proof-of-concept data in celiac disease showing a dose-dependent increase in endogenous GLP-1 [2][3]. - **Vidofludimus Calcium**: - Phase III molecule for relapsing forms of multiple sclerosis (MS). - Addresses both neuroinflammation and neurodegeneration, which are critical in MS progression [3][5]. Unmet Need in Multiple Sclerosis - MS leads to significant physical and cognitive disabilities. - Current therapies primarily address neuroinflammation but do not halt chronic disability accumulation. - Vidofludimus calcium aims to provide neuroprotective benefits alongside anti-inflammatory effects [3][4][5]. Mechanism of Action - **Dual Mechanistic Approach**: - Inhibits dihydroorotate dehydrogenase (DHODH) to reduce inflammation. - Activates nuclear receptor-related protein 1 (NRR-1) for neuroprotection [5][6]. - **Epstein-Barr Virus**: - Vidofludimus calcium may prevent reactivation of this virus, which is linked to MS symptoms [6][7]. Clinical Data - **Phase II EMPhASIS Study**: - 268 patients; significant reduction in cumulative active lesions (76%) and gadolinium-enhanced lesions (80%) at week 24 with 30 mg dose [11]. - Confirmed disability worsening was 1.6% for vidofludimus calcium vs. 3.7% for placebo, indicating over 50% benefit [11][12]. - Long-term follow-up showed less than 8% of patients reported confirmed disability worsening at week 144 [12]. - Significant reductions in serum neurofilament light chain, a biomarker for disability worsening [13]. - **Safety Profile**: - Low discontinuation rates (2.8%) compared to other therapies (e.g., Aubagio at 20%) [14]. - No increased risk of serious infections or hepatotoxicity observed [14]. Ongoing Studies - **ENSURE I and ENSURE II**: - Phase III studies fully enrolled with over 1,100 patients each, focusing on time to first relapse [16]. - Expected top-line data in late 2026 [16]. - **CALIBRATE Study**: - Exploratory Phase II study for progressive MS, showing a 31% reduction in disability worsening for primary progressive MS [17][18]. Market Opportunity - **Market Size**: - MS market valued at $23 billion, projected to grow to $30 billion [20]. - Vidofludimus calcium could capture a significant share as the first oral disease-modifying therapy for both relapsing and progressive MS [20][21]. - **Potential Revenue**: - Estimated $1 billion to $2 billion opportunity in relapsing MS and over $2 billion in progressive MS if successful [21]. Conclusion - Vidofludimus calcium represents a transformative opportunity in the MS market with its dual mechanism of action and favorable safety profile. - The company anticipates significant commercial potential if ongoing studies confirm its efficacy [21][22].