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]

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 ...

Core Insights - Immunic Inc's CEO Dr. Daniel Vitt highlighted the promising results from the Phase 2 CALLIPER trial of vidofludimus calcium, showing a 24% reduction in disability progression across the full study population, with over 30% reduction in patients with primary progressive MS [1][2]. Clinical Progress - The CALLIPER study aimed to analyze the neuroprotective effect of vidofludimus calcium in patients with progressive forms of multiple sclerosis, addressing a significant unmet medical need [2]. - The CALLIPER data is deemed important for various forms of MS, including primary progressive, secondary progressive, and relapsing MS, with ongoing Phase 3 ENSURE studies expected to benefit from the drug's neuroprotective features [3]. Trial Enrollment and Milestones - The company completed enrollment for both ENSURE trials, involving a total of 2,200 patients, marking a significant milestone in the quarter [4]. - The trials are set to read out next year, indicating a step closer to potential new treatment options for patients with relapsing MS [4]. EMPhASIS Trial Results - New data from the Phase 2 EMPhASIS trial indicated that over 90% of patients treated with vidofludimus calcium for 144 weeks were free of disability progression, showcasing the drug's effectiveness [6]. Financial Position - The company strengthened its balance sheet through two financings, positioning itself well to advance its clinical trials, particularly the Phase 3 studies in relapsing MS [7][8].

Core Insights - Immunic, Inc. has made significant clinical advancements with its lead asset, vidofludimus calcium, particularly in multiple sclerosis treatment, showing promising results in various trials [2][11] - The company has completed enrollment for its phase 3 ENSURE trials, with top-line data expected by the end of 2026, indicating progress towards a potential new treatment option for relapsing multiple sclerosis [2][11] - Financially, Immunic has strengthened its balance sheet with two financings totaling $70.1 million in gross proceeds, although it reported a net loss of approximately $27 million for the second quarter of 2025 [6][9] Clinical Developments - The phase 2 CALLIPER trial demonstrated a 23.8% reduction in time to 24-week confirmed disability worsening in the overall progressive multiple sclerosis population compared to placebo, with even higher reductions in specific subgroups [2][7] - Long-term open-label extension data from the phase 2 EMPhASIS trial showed that 92.3% of patients remained free of 12-week confirmed disability worsening at week 144, reinforcing the drug's efficacy [2][6] - Vidofludimus calcium's neuroprotective effects are believed to be mediated through activation of the Nurr1 target, which may address the complex pathophysiology of multiple sclerosis [2][11] Financial Performance - Research and Development (R&D) expenses for the second quarter of 2025 were $21.4 million, an increase from $18.3 million in the same period of 2024, primarily due to higher external development costs related to vidofludimus calcium [6][8] - General and Administrative (G&A) expenses also increased to $5.7 million for the second quarter of 2025, compared to $4.5 million in the prior year [8] - The company reported a net loss of approximately $27 million for the second quarter of 2025, with a net loss per share of $0.20, reflecting a slight improvement from a net loss of $21.4 million in the same quarter of 2024 [9][14] Market Potential - The market for primary progressive multiple sclerosis is estimated to exceed $6 billion, with vidofludimus calcium positioned as a promising treatment option in this underserved area [2][11] - The company is also preparing for further clinical testing of IMU-856, which targets gastrointestinal disorders and may offer a novel therapeutic approach [3][4]

Core Viewpoint - Immunic Inc reported positive data from the phase 2 EMPhASIS trial of vidofludimus calcium for relapsing-remitting multiple sclerosis (RRMS), indicating a low rate of confirmed disability worsening in treated patients, which supports the drug's potential neuroprotective effects [2][4]. Group 1: Trial Results - The EMPhASIS trial demonstrated a significant reduction in inflammatory lesions on MRI, with 30 mg and 45 mg doses showing reductions of 76% and 78% respectively [4]. - The trial also indicated initial signs of neuroprotection, with a reduction in disability progression by more than 50% [4][5]. - A total of 268 patients were randomized, with 254 entering the open-label extension phase, and 182 remaining on active treatment as of January, highlighting the drug's safety and tolerability [3]. Group 2: Importance of Disability Worsening - Confirmed disability worsening (CDW) is a critical concern for MS patients, as it relates to their independence over time, measured by the EDSS disability score [6]. - The data from the EMPhASIS trial suggests that vidofludimus calcium may address the unmet need to slow down disability progression independent of relapse activity [6]. Group 3: Future Development Plans - Based on the EMPhASIS data, Immunic plans to conduct two phase 3 studies (ENSURE studies) in relapsing MS, with 1,122 patients enrolled, expected to read out by the end of next year [7]. - The studies will also assess the long-term neuroprotective effects as a secondary endpoint, which is crucial for the drug's positioning [8]. - The CALLIPER phase 2 study confirmed a 24% reduction in overall CDW and a 32% reduction in the primary progressive MS subgroup for patients treated with 45 mg, reinforcing the drug's potential efficacy [10].