更新于：2024-04-01

Multiple Sclerosis, Relapsing-Remitting

复发-缓解型多发性硬化

更新于：2024-04-01

基本信息

别名

Acute Relapsing Multiple Sclerosis、Acute relapsing multiple sclerosis、Acute relapsing multiple sclerosis (diagnosis)

+ [28]

简介

The most common clinical variant of MULTIPLE SCLEROSIS, characterized by recurrent acute exacerbations of neurologic dysfunction followed by partial or complete recovery. Common clinical manifestations include loss of visual (see OPTIC NEURITIS), motor, sensory, or bladder function. Acute episodes of demyelination may occur at any site in the central nervous system, and commonly involve the optic nerves, spinal cord, brain stem, and cerebellum. (Adams et al., Principles of Neurology, 6th ed, pp903-914)

关联

项与复发-缓解型多发性硬化相关的药物

Natalizumab Biosimilar (Polpharma Biologics)

那他珠单抗生物类似药 (Polpharma Biologics)

靶点

CD49d

作用机制

CD49d拮抗剂

在研机构

Sandoz, Inc. [+2]

原研机构

Polpharma Biologics S.A.

在研适应症

复发-缓解型多发性硬化 [+2]

非在研适应症-

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2023-08-24

Ublituximab

靶点

CD20

作用机制

CD20抑制剂 [+4]

在研机构

TG Therapeutics, Inc. [+2]

原研机构

rEVO Biologics, Inc. [+1]

在研适应症

复发性多发性硬化 [+4]

非在研适应症

复发性B细胞淋巴瘤 [+21]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2022-12-28

Fingolimod Lauryl Sulfate

靶点

S1PRs

作用机制

S1PRs调节剂 [+1]

在研机构

Cycle Pharmaceuticals Ltd.

原研机构

汉达生技医药股份有限公司

在研适应症

临床孤立综合征 [+3]

非在研适应症-

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2021-12-23

862

项与复发-缓解型多发性硬化相关的临床试验

NCT04768777 / Not yet recruitingN/AIIT

Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis

The prevalence of sexual dysfunction is higher among women with multiple sclerosis (MS) than women in the general population. The presence of sexual dysfunction is associated with decreased well-being and quality of life. There is limited research supporting pharmacological and other therapeutic approaches for managing sexual dysfunction in MS. Physical activity has beneﬁcial eﬀects on many of the consequences of MS, and physical activity represents a promising non-pharmacological approach for managing symptoms of sexual dysfunction in MS. The proposed research examines the eﬀect of an Internet-delivered lifestyle physical activity intervention for improving sexual dysfunction in women with MS. The research proposed, if successful, will provide evidence for the eﬃcacy of physical activity as a translatable approach for managing sexual dysfunction among women with MS.

开始日期2024-12-01

申办/合作机构

The University of Alabama at Birmingham

[+1]

NCT06325358 / Not yet recruitingN/A

EXPOSITION (EXPosome, Oxidative Stress and InflammaTION) in Persons With Multiple Sclerosis Study

This is a cross-sectional study to evaluate the variation of biological biomarkers of oxidative stress and inflammation in response to the external exposome, in people with Multiple Sclerosis (pwMS).The objective is to study the variation of biological biomarkers of oxidative stress and inflammation in response to external exposome in pwMS, controlling for other biomarkers (cytokine, neurofilaments, microbiome), gender, age, anthropometric measurements, vitamin D levels and medical history. Specifically, the variation of microRNAs is defined as the primary outcome, in response to urban air pollution, urbanization, lifestyle and quality of life components of the external exposome. Following the functional exposome approach:(1)Information on a pwMS sample about socio-demographic characteristics and medical history will be collected and specific components of the (2) On the same pwMS sample, the internal exposome variation will be measured. MicroRNA levels and gut and nasal microbiota alpha- and beta-diversity and relative bacterial abundances will be considered as biomarkers of oxidative stress and inflammation. At the same time, cytokines and neurofilament proteins (NfL) will be measured as biomarkers of neurodegeneration and axonal damage. Adults (≥ 18 years) pwMS, with relapsing-remitting course, diagnosis of MS according to 2017 McDonald criteria and residing in Pavia or Milan (Italy) will be included. Potentially eligible pwMS will be screened by a neurologist expert in MS who will verify that all the inclusion criteria will be fulfilled. To validate variation among 7 selected MS diagnostic miRNA, in response to urban air pollution, urbanization, lifestyle and quality of life components of the external exposome, the differential expression (ΔCT) for each miRNA will be considered as the outcome measure. Two hundred eligible pwMS who meet the inclusion criteria and sign the informed consent will be included in the study, to consider 15% dropout at the blood sampling stage.

开始日期2024-04-15

申办/合作机构

Universitiamo By Unipv

[+2]

NCT05949580 / Not yet recruitingN/A

Study to Evaluate the Usability of Introducing Integrated Digital Solutions Into Clinical Practice and the Value of Their Use in the Medical Care of Patients With Multiple Sclerosis (MS)

The main purpose of this study is to assess the usability and value of the multiple sclerosis (MS) care management platform in terms of improved monitoring of people with MS (pwMS) in clinical practice.
This is a two-year prospective data collection study with additional data collection at baseline evaluating medical practice over a period of at least one year before the introduction of the MS care management platform.

开始日期2024-03-31

申办/合作机构

Hoffmann-La Roche Ltd.

[+1]

100 项与复发-缓解型多发性硬化相关的临床结果

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100 项与复发-缓解型多发性硬化相关的转化医学

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0 项与复发-缓解型多发性硬化相关的专利（医药）

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10,219

项与复发-缓解型多发性硬化相关的文献（医药）

2024-03-12·Neurology

Effect of Evobrutinib on Slowly Expanding Lesion Volume in Relapsing Multiple Sclerosis: A Post Hoc Analysis of a Phase 2 Trial.

Article

作者: Douglas L Arnold ; Colm Elliott ; Emily C Martin ; Yann Hyvert ; Davorka Tomic ; Xavier Montalban

BACKGROUND AND OBJECTIVES:

Chronic active lesions (CALs) are demyelinated multiple sclerosis (MS) lesions with ongoing microglia/macrophage activity, resulting in irreversible neuronal damage and axonal loss. Evobrutinib is a highly selective, covalent, CNS-penetrant, Bruton tyrosine kinase inhibitor. This post hoc analysis evaluated the effect of evobrutinib on slowly expanding lesion (SEL) volume, an MRI marker of CALs, assessed baseline-week 48 in a phase 2, double-blind, randomized trial (NCT02975349) in relapsing MS (RMS).

METHODS:

In the 48-week, double-blind trial, adult patients received evobrutinib (25 mg once daily [QD], 75 mg QD, or 75 mg twice daily [BID]), placebo (switched to evobrutinib 25 mg QD after week 24), or open-label dimethyl fumarate (DMF) 240 mg BID. SELs were defined as slowly and consistently radially expanding areas of preexisting T2 lesions of ≥10 contiguous voxels (∼30 mm³) over time. SELs were identified by MRI and assessed by the Jacobian determinant of the nonlinear deformation from baseline to week 48. SEL volume analysis, stratified by baseline T2 lesion volume tertiles, was based on week 48/end-of-treatment status (completers/non-completers). Treatment effect was analyzed using the stratified Hodges-Lehmann estimate of shift in distribution and stratified Wilcoxon rank-sum test. Comparisons of evobrutinib and DMF vs placebo/evobrutinib 25 mg QD were made. Subgroup analyses used pooled treatment groups (evobrutinib high dose [75 mg QD/BID] vs low dose [placebo/evobrutinib 25 mg QD]).

RESULTS:

The SEL analysis set included 223 patients (mean [SD] age: 42.4 [10.7] years; 69.3% female; 87.4% relapsing/remitting MS). Mean (SD) SEL volume was 2,099 (2,981.0) mm³ with evobrutinib 75 mg BID vs 2,681 (3,624.2) mm³ with placebo/evobrutinib 25 mg QD. Median number of SELs/patient ranged from 7 to 11 across treatments. SEL volume decreased with increasing evobrutinib dose vs placebo/evobrutinib 25 mg QD, and no difference with DMF vs placebo/evobrutinib 25 mg QD was noted. SEL volume significantly decreased with evobrutinib 75 mg BID vs placebo/evobrutinib 25 mg QD (-474.5 mm³ [-1,098.0 to -3.0], p = 0.047) and vs DMF (-711.6 [-1,290.0 to -149.0], p = 0.011). SEL volume was significantly reduced for evobrutinib high vs low dose within baseline Expanded Disability Status Scale ≥3.5 and longer disease duration (≥8.5 years) subgroups.

DISCUSSION:

Evobrutinib reduced SEL volume in a dose-dependent manner in RMS, with a significant reduction with evobrutinib 75 mg BID. This is evident that evobrutinib affects brain lesions associated with chronic inflammation and tissue loss.

TRIAL REGISTRATION INFORMATION:

ClinicalTrials.gov number: NCT02975349. Submitted to ClinicalTrials.gov on November 29, 2016. First patient enrolled: March 7, 2017.

CLASSIFICATION OF EVIDENCE:

This study provides Class II evidence that evobrutinib reduces the volume of SELs assessed on MRI comparing baseline with week 48, in patients with RMS.

2024-03-12·Neurology

Investigating the Prevalence of Comorbidity in Multiple Sclerosis Clinical Trial Populations.

Article

作者: Amber Salter ; Samantha Lancia ; Kaarina Kowalec ; Kathryn C Fitzgerald ; Ruth Ann Marrie

BACKGROUND AND OBJECTIVES:

Comorbidity is common in multiple sclerosis (MS) with the most prevalent conditions being depression, anxiety, hypertension, and hyperlipidemia. Limited information regarding the representation of comorbidity status is available from phase III clinical trials in MS leading to concern about the potential underrepresentation of individuals with comorbidity in clinical trials. The objective was to estimate the prevalence of comorbidities in MS clinical trial populations.

METHODS:

Individual-level data from multiple sponsors were requested for a 2-stage meta-analysis of phase III clinical trials of MS disease-modifying therapies. To ensure consistency of our approach across trials, we followed the Maelstrom retrospective harmonization guidelines. Chronic comorbidities at clinical trial enrollment recommended by the International Advisory Committee on Clinical Trials in MS were considered (depression, anxiety, hypertension, hyperlipidemia, migraine, diabetes, chronic lung disease). Additional comorbidities were also classified. Classification was based on medical history data. Individual comorbidities were summed and categorized as 0, 1, 2, or ≥3. We report the pooled prevalence (95% confidence interval [95% CI]) of comorbidity. The pooled prevalence and prevalence ratios across age, sex, race, disability level, and treatment were also reported. Heterogeneity was assessed using the I² statistic.

RESULTS:

Seventeen trials involving 17,926 participants were included. Fourteen trials enrolled participants with relapsing MS (RMS) while 3 enrolled participants with progressive MS (PMS). The distributions of sex, age, and disability level were generally consistent within RMS and PMS trials. When pooled, almost half of trial participants (46.5%) had ≥1 comorbidity (1: 25.0%, 95% CI 23.0-27.0, I² = 89.9; 2: 11.4% [9.3-14.0], I² = 96.3; ≥3: 6.0% [4.2-8.4], I² = 97.7). Depression (16.45% [12.96-20.88], I² = 98.3) was the most prevalent comorbidity reported, followed by hypertension (10.16% [8.61-11.98], I² = 93.2). Heterogeneity was high across trials. Older age and female participants were associated with increased number of comorbidities. Older individuals and male participants had a higher prevalence of hyperlipidemia, while older individuals and female participants had a higher prevalence of depression and anxiety.

DISCUSSION:

Individuals with comorbidities are included in clinical trials, although they may still be underrepresented compared with the general MS population. Given the comorbidity prevalence in the trial populations and studies suggesting an association of comorbidities with disease activity, comorbidity may influence outcomes in clinical trials.

2024-03-01·Neurology(R) neuroimmunology & neuroinflammation

CXCL10/IgG1 Axis in Multiple Sclerosis as a Potential Predictive Biomarker of Disease Activity.

Article

作者: Nora Welsh ; Krista Disano ; Michael Linzey ; Steven C Pike ; Andrew D Smith ; Andrew R Pachner ; Francesca Gilli

BACKGROUND AND OBJECTIVES:

Multiple sclerosis (MS) is a heterogeneous disease, and its course is difficult to predict. Prediction models can be established by measuring intrathecally synthesized proteins involved in inflammation, glial activation, and CNS injury.

METHODS:

To determine how these intrathecal proteins relate to the short-term, i.e., 12 months, disease activity in relapsing-remitting MS (RRMS), we measured the intrathecal synthesis of 46 inflammatory mediators and 14 CNS injury or glial activation markers in matched serum and CSF samples from 47 patients with MS (pwMS), i.e., 23 RRMS and 24 clinically isolated syndrome (CIS), undergoing diagnostic lumbar puncture. Subsequently, all pwMS were followed for ≥12 months in a retrospective follow-up study and ultimately classified into "active", i.e., developing clinical and/or radiologic disease activity, n = 18) or "nonactive", i.e., not having disease activity, n = 29. Disease activity in patients with CIS corresponded to conversion to RRMS. Thus, patients with CIS were subclassified as "converters" or "nonconverters" based on their conversion status at the end of a 12-month follow-up. Twenty-seven patients with noninflammatory neurologic diseases were included as negative controls. Data were subjected to differential expression analysis and modeling techniques to define the connectivity arrangement (network) between neuroinflammation and CNS injury relevant to short-term disease activity in RRMS.

RESULTS:

Lower age and/or higher CXCL13 levels positively distinguished active/converting vs nonactive/nonconverting patients. Network analysis significantly improved the prediction of short-term disease activity because active/converting patients featured a stronger positive connection between IgG1 and CXCL10. Accordingly, analysis of disease activity-free survival demonstrated that pwMS, both RRMS and CIS, with a lower or negative IgG1-CXCL10 correlation, have a higher probability of activity-free survival than the patients with a significant correlation (p < 0.0001, HR ≥ 2.87).

DISCUSSION:

Findings indicate that a significant IgG1-CXCL10 positive correlation predicts the risk of short-term disease activity in patients with RRMS and CIS. Thus, the present results can be used to develop a predictive model for MS activity and conversion to RRMS.

341

项与复发-缓解型多发性硬化相关的新闻（医药）

2024-03-29

·FiercePharma

Bristol Myers Squibb's versatile Zeposia doesn't make the grade in Crohn's disease trial

Bristol Myers Squibb’s Zeposia gained first-in-class nods to treat multiple sclerosis and ulcerative colitis. But the company’s attempt to expand into Crohn’s disease has hit a setback. Bristol Myers Squibb’s Zeposia (ozanimod) has attracted attention as a treatment for an unusual duo of diseases—multiple sclerosis (MS) and ulcerative colitis (UC). But the approval roll for the sphingosine 1-phosphate (S1P) receptor modulator may be over. Thursday, the New Jersey company said its trial assessing Zeposia in Crohn’s disease had come up short. The company said an initial analysis of results from a 12-week induction study showed that the drug did not meet its primary endpoint of clinical remission at Week 12. BMS did not provide detailed data nor reveal its plan for Zeposia in the indication. “To date, no S1P modulator has shown an effect in a phase 3 trial in Crohn’s disease, where a high unmet medical need remains for new therapies that offer more patients relief from symptoms and the potential for remission,” Roland Chen, M.D., BMS’ head of immunology, cardiovascular and neuroscience development, said in a release. The trial enrolled 600 participants who did not have success with at least one prior treatment and is the first of two 12-week induction studies comparing Zeposia to placebo. Also part of the YELLOWSTONE program is a 52-week maintenance study for those who responded to treatment and an optional, 264-week, open-label extension study open to non-responders, plus those with disease relapse during maintenance and those who completed the maintenance trial. Zeposia was approved for relapsing MS in 2020. A year later came the UC nod, providing patients with a first-in-class alternatives to biologic treatments such as Johnson & Johnson’s Stelara, AbbVie’s Humira and Takeda’s Entyvio, which have dominated the indication. Zeposia is administered orally as opposed to the biologics, which are infused. Another S1P receptor modulator joined the competition in October of last year with the FDA approval of Pfizer’s Velsipity, which was gained in the $6.7 billion acquisition of Arena Pharmaceuticals. Velsipity also is being investigated in a pahse 2/3 trial as a treatment for Crohn's disease. Zeposia generated $434 million in sales last year, which was up 74% from 2022. BMS has estimated Zeposia will reach sales of $3 billion by 2030.

临床3期并购上市批准临床结果

2024-03-21

·BioSpace

SetPoint Medical Accepted into FDA Total Product Life Cycle Advisory Program for Development of its Neuroimmune Modulation Platform for the Treatment of Multiple Sclerosis

Acceptance into the TAP Pilot will help expedite regulatory and patient access pathways for a first-of-its-kind therapeutic approach for people with relapsing-remitting multiple sclerosis (RRMS) TAP Pilot acceptance follows Breakthrough Device Designation announcement for the treatment of RRMS VALENCIA, Calif.--(BUSINESS WIRE)-- SetPoint Medical, a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, announced that it has been accepted into the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot from the U.S. Food and Drug Administration (FDA) for the development of its novel neuroimmune modulation platform for people living with relapsing-remitting multiple sclerosis (RRMS). The FDA’s Center for Devices and Radiological Health (CDRH) launched the TAP Pilot to help expedite development and patient access to safe and effective high-quality medical devices upon FDA approval. In October 2023, the FDA expanded the program to include neurological and physical medicine devices. To help accelerate development of SetPoint’s device, the TAP Pilot will allow the company to have earlier and more frequent interactions with providers, payors and patients, as well as proactive, strategic advice from the CDRH. “We’re excited to be included in the TAP Pilot as the program will help streamline collaboration with the FDA - from initiating the first-of-its-kind clinical trial evaluating this approach for people living with RRMS, to accelerating access to this breakthrough therapy upon approval,” said Alexis Dineen, Vice President of Regulatory Affairs at SetPoint Medical. “Ultimately, this program highlights the FDA's commitment to spur development and widespread access of safe and effective treatment options to the people that need them most.” The TAP Pilot acceptance follows the recent announcement that the FDA granted Breakthrough Device Designation to SetPoint's device for the treatment of RRMS, based on evidence demonstrating that the device has the potential to reduce demyelination and promote remyelination. In addition, SetPoint has also received Breakthrough Device Designation for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA), and is studying the safety and effectiveness of this application in a pivotal clinical trial, the RESET-RA study. SetPoint's integrated neurostimulation device uses precise vagus nerve stimulation to activate innate anti-inflammatory and immune-restorative pathways to treat autoimmune conditions. After placement during an outpatient procedure, the device is programmed to automatically deliver therapy on a preset schedule by stimulating the vagus nerve once daily to activate the inflammatory reflex for a systemic immune-restorative effect. About SetPoint Medical SetPoint Medical is a privately held clinical-stage healthcare company dedicated to treating patients with chronic autoimmune diseases. The company is developing a novel platform designed to stimulate the vagus nerve to activate the inflammatory reflex to produce a systemic immune-restorative effect. SetPoint Medical’s platform technology is designed to offer patients and providers a treatment alternative for rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease and other chronic autoimmune conditions with potentially less risk and cost than drug therapy. For more information, visit . View source version on businesswire.com: Contacts Tressa Frankel Health+Commerce 224.567.1447 media@setpointmedical.com Source: SetPoint Medical View this news release online at:

突破性疗法

2024-03-20

·BioSpace

Immunic Receives Notice of Allowance for Composition-of-Matter Patent of a Specific Polymorph of Vidofludimus Calcium in the United States

Patent Will Also Cover a Related Method of Production of the Material Fourth U.S. Patent Directed to Use of Vidofludimus Calcium in Multiple Sclerosis Multilayered Intellectual Property Strategy Provides Protection Into 2041 in the United States and Into 2039 Internationally, Unless Extended Further NEW YORK, March 20, 2024 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application 16/981,122, entitled, "Calcium salt polymorphs as anti-inflammatory, immunomodulatory and anti-proliferative agents," covering the composition-of-matter of a specific polymorph of vidofludimus calcium (IMU-838) and a related method of production of the material. The claims are expected to provide protection into 2039, unless extended further. The patent was previously granted to the company in Australia, Canada, Indonesia, Japan and Mexico. "Allowance of this key composition-of-matter patent, covering the specific polymorph of vidofludimus calcium, provides another important layer of proprietary intellectual property protection around our lead, late-stage asset," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "A significant part of this patent will also cover the related method of producing material of vidofludimus calcium used in our studies. Importantly, we meanwhile have eight patent families active for vidofludimus. Our commitment to protecting the technology behind this phase 3 asset remains paramount and is made that much stronger by the addition of this fourth U.S. patent directed to the use of vidofludimus calcium in multiple sclerosis." Vidofludimus calcium is covered by several layers of granted patents in the United States, Europe and other jurisdictions around the world. These patents are directed towards composition-of-matter for salt forms of vidofludimus, including the specific calcium salt form used in Immunic's clinical trials; the treatment of relapsing multiple sclerosis with a specific dose strength used in the clinical trials; the dosing regimens, including those used in clinical trials for the treatment of multiple sclerosis; as well as composition-of-matter of a specific polymorph of vidofludimus calcium and a related method of production of the material, as reported in this announcement. In the United States, these patents provide protection into 2041, unless extended further. In addition, a pending application is directed towards the use of vidofludimus calcium and other salt forms as well as free acid forms for treating neurodegenerative diseases. If granted, this application could provide protection up to 2044, unless extended further. Finally, further undisclosed patent applications dedicated to strengthening the exclusivity period are currently in process. On top of the patent exclusivity, vidofludimus calcium, as a new chemical entity, should also benefit from regulatory data protection. About Vidofludimus Calcium (IMU-838) Vidofludimus calcium is a small molecule investigational drug in development as an oral next-generation treatment option for patients with multiple sclerosis and other chronic inflammatory and autoimmune diseases. The selective immune modulator activates the neuroprotective transcription factor nuclear receptor related 1 (Nurr1), which is associated with direct neuroprotective properties. Additionally, vidofludimus calcium is a known inhibitor of the enzyme dihydroorotate dehydrogenase (DHODH), which is a key enzyme in the metabolism of overactive immune cells and virus-infected cells. This mechanism is associated with the anti-inflammatory and anti-viral effects of vidofludimus calcium. Vidofludimus calcium has been observed to selectively act on hyperactive T and B cells while leaving other immune cells largely unaffected and enabling normal immune system function, e.g., in fighting infections. To date, vidofludimus calcium has been tested in more than 1,800 individuals and has shown an attractive pharmacokinetic, safety and tolerability profile. Vidofludimus calcium is not yet licensed or approved in any country. About Immunic, Inc. Immunic, Inc. (Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 and phase 2 clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe ulcerative colitis. 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). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, for which it is currently in preparations for a phase 2 clinical trial. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: . Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for vidofludimus calcium to safely and effectively target diseases; preclinical and clinical data for vidofludimus calcium; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the COVID-19 pandemic, increasing inflation, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 22, 2024, and in the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release. Contact Information Immunic, Inc. Jessica Breu Vice President Investor Relations and Communications +49 89 2080 477 09 jessica.breu@imux.com US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 immunic@rxir.com US Media Contact KOGS Communication Edna Kaplan +1 617 974 8659 kaplan@kogspr.com View original content to download multimedia: SOURCE Immunic, Inc. Company Codes: NASDAQ-NMS:IMUX

临床2期临床结果临床3期