Immunic Receives Notice of Allowance for United States Patent Protecting Vidofludimus Calcium's Dose Strengths in Progressive Multiple Sclerosis
MWN-AI** Summary
Immunic, Inc. (Nasdaq: IMUX), a biotechnology firm focused on oral small molecule therapies for chronic inflammatory and autoimmune diseases, announced a significant milestone with the receipt of a Notice of Allowance from the United States Patent and Trademark Office for an essential patent concerning its lead asset, vidofludimus calcium (IMU-838). This newly granted patent will cover specific dose strengths for treating progressive forms of multiple sclerosis (PMS), including primary and secondary progressive multiple sclerosis (PPMS and SPMS). With protection expected to extend into 2041, this patent fortifies Immunic's strong intellectual property strategy amidst growing clinical validation for vidofludimus calcium.
Videofludimus calcium has demonstrated potential in recent phase 2 clinical trials, showing neuroprotective effects by significantly delaying disability worsening in PMS patients. These promising results align with a greater reduction in thalamic brain volume loss and the incidence of new T2 lesions—further validating the drug’s therapeutic efficacy.
Daniel Vitt, Ph.D., Immunic’s CEO, emphasized that this patent allowance is a pivotal advancement for their PMS program, especially following encouraging trial outcomes. The protection afforded by this patent allows Immunic to explore discussions with healthcare authorities regarding pivotal phase 3 trials, aiming to address the unmet medical needs in progressive multiple sclerosis treatment.
This announcement adds to the multi-layered patent protections already in place for vidofludimus calcium across various global markets, including the composition of matter and dosing regimens. As the company positions itself for future growth, the robust patent portfolio underscores its commitment to developing innovative treatments in areas with significant therapeutic gaps. Investors and stakeholders are likely to watch closely as the company advances its clinical trials and navigates potential regulatory pathways.
MWN-AI** Analysis
Immunic, Inc. (Nasdaq: IMUX) recently announced a Notice of Allowance from the USPTO for a patent application that protects the dosing strengths of its lead investigational asset, vidofludimus calcium, in treating progressive multiple sclerosis (PMS). This is a significant milestone, as it enhances Immunic's intellectual property portfolio, potentially securing market exclusivity until 2041. Such protections are crucial for biotechnology firms, allowing them to capitalize on their innovations, especially in a therapeutic area with high unmet medical needs.
The patent's timing is also noteworthy, following positive results from the phase 2 CALLIPER trial, where vidofludimus calcium demonstrated neuroprotective properties and the ability to delay disability worsening in PMS patients. Moreover, the anticipated transition into phase 3 trials could bolster investor confidence, as clinical validation is paramount for biopharmaceutical success.
From a market perspective, this development signals a robust growth opportunity. The pharmaceutical landscape is increasingly competitive, and successful patent claims can enhance revenues through limited competition. Analysts should monitor the upcoming data releases and regulatory discussions, as they will provide clarity on the drug’s market readiness and potential sales.
Investors interested in biotech stocks should take note of Immunic's strategic positioning; with several layers of patent protection and ongoing clinical trials, IMUX may represent a compelling investment opportunity in a promising sector. However, potential investors should remain cautious of biotech volatility and the inherent risks surrounding trial outcomes and regulatory approvals. Diversification may mitigate some risks associated with this investment. Overall, Immunic's advancements position it favorably within the market, but active monitoring of upcoming developments is advised.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
PR Newswire
– Fifth U.S. Patent Directed to Use of Vidofludimus Calcium in Multiple Sclerosis –
– Comprehensive Intellectual Property Strategy Secures Protection Into 2041 in the U.S., Unless Extended Further –
NEW YORK , Sept. 9, 2025 /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 18/529,946, entitled, "Treatment of multiple sclerosis comprising DHODH inhibitors."
Specifically, the resulting patent covers dose strengths associated with lead asset, vidofludimus calcium (IMU-838), and other salt forms as well as free acid forms, at a daily dose of about 10 mg to 45 mg, for the treatment of progressive multiple sclerosis (PMS), including the sub-groups primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS). The patent is expected to provide protection into 2041, and potential Patent Term Extension may offer additional market exclusivity in the United States .
"Allowance of this new key patent represents a significant advancement for our vidofludimus calcium program in PMS and further strengthens its robust, multi-layered intellectual property portfolio," stated Daniel Vitt , Ph.D., Chief Executive Officer of Immunic. "The patent comes at a pivotal time, closely on the heels of our positive phase 2 CALLIPER trial data in PMS. Vidofludimus calcium continued to demonstrate neuroprotective potential by delaying time to 24-week confirmed disability worsening (24wCDW), supporting its ability to slow disease progression in multiple sclerosis patients, with or without focal inflammation. These findings also reinforce the reductions in the annualized rate of thalamic brain volume loss and volume of new/enlarging T2 lesions seen in the CALLIPER trial. Given that 24wCDW would be an acceptable regulatory endpoint of a pivotal phase 3 trial, we look forward to continuing to discuss the opportunity with healthcare authorities to determine next steps toward our goal of bringing this novel and exciting approach to patients with progressive forms of multiple sclerosis, where there continues to be a significant unmet medical need."
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 and progressive 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. In the United States , these patents provide protection into 2041, or even beyond. 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 an orally administered investigational small molecule drug being developed for chronic inflammatory and autoimmune diseases, currently in late-stage clinical trials for multiple sclerosis (MS). Uniquely, vidofludimus calcium's first-in-class, dual mode of action combines neuroprotective, anti-inflammatory and anti-viral effects to target the complex pathophysiology of MS. As a selective immune modulator, it activates the neuroprotective transcription factor, nuclear receptor-related 1 (Nurr1), which provides direct and indirect neuroprotective effects. Additionally, vidofludimus calcium achieves anti-inflammatory and anti-viral effects through highly selective inhibition of the enzyme dihydroorotate dehydrogenase (DHODH). Vidofludimus calcium is currently being evaluated in phase 3 clinical trials for the treatment of relapsing MS. In a phase 2 clinical trial, it has shown therapeutic activity in relapsing-remitting MS patients, significantly reducing brain lesions and demonstrating encouraging results in reducing confirmed disability worsening. Additionally, vidofludimus calcium has demonstrated clinical benefits in progressive MS patients by showing substantial reductions in confirmed disability worsening and thalamic brain volume in a phase 2 clinical trial. To date, vidofludimus calcium has been exposed to approximately 2,700 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 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 patients suffering from relapsing-remitting multiple sclerosis and progressive multiple sclerosis. 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 as well as inflammatory bowel disease, Graft-versus-Host-Disease and weight management. 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: www.imux.com .
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 and cash runway, 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, increasing inflation, tariffs and macroeconomics trends, 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, any changes to the size of the target markets for the Company's products or product candidates, 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, 2024 , filed with the SEC on March 31, 2025 , and in the company's subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov 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 of 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
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com
SOURCE Immunic, Inc.
FAQ**
How does the Notice of Allowance for the patent protecting vidofludimus calcium's dose strengths in progressive multiple sclerosis impact Immunic Inc. (IMUX) in terms of market exclusivity and competitive advantage?
With the patent protection extending to 2041, how does Immunic Inc. (IMUX) plan to leverage this intellectual property to enhance its commercial strategy for vidofludimus calcium in multiple sclerosis?
What are the expected implications of the positive phase 2 CALLIPER trial data on Immunic Inc. (IMUX)'s strategy for advancing vidofludimus calcium into pivotal phase 3 clinical trials?
How does Immunic Inc. (IMUX) intend to address the significant unmet medical need for treatments in progressive multiple sclerosis, especially with the intellectual property advancements related to vidofludimus calcium?
**MWN-AI FAQ is based on asking OpenAI questions about Immunic Inc. (NASDAQ: IMUX).
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