Immunic Receives Notice of Allowance for United States Patent Protecting Vidofludimus Calcium's Dose Strengths in Progressive Multiple Sclerosis
Immunic (NASDAQ:IMUX) has received a Notice of Allowance from the USPTO for a patent application covering dose strengths of its lead asset vidofludimus calcium (IMU-838) for treating progressive multiple sclerosis (PMS). The patent specifically covers daily doses of 10-45mg for treating PMS, including primary and secondary progressive forms.
The patent provides protection until 2041 and follows positive phase 2 CALLIPER trial results where vidofludimus calcium demonstrated neuroprotective potential by delaying time to 24-week confirmed disability worsening (24wCDW). The drug also showed reductions in thalamic brain volume loss and volume of new/enlarging T2 lesions.
This is the fifth U.S. patent for vidofludimus calcium in multiple sclerosis, part of a multi-layered intellectual property strategy that includes patents for composition-of-matter, treatment methods, and dosing regimens.
Immunic (NASDAQ:IMUX) ha ricevuto una Notice of Allowance dall'USPTO per una domanda di brevetto che riguarda le dosi del suo principale composto, vidofludimus calcium (IMU-838), nel trattamento della sclerosi multipla progressiva (PMS). Il brevetto riguarda specificamente dosi giornaliere da 10 a 45 mg per il trattamento della PMS, incluse le forme primarie e secondarie progressive.
La protezione brevettuale coprir脿 fino al 2041 e segue i risultati positivi della fase 2 dello studio CALLIPER, in cui vidofludimus calcium ha mostrato potenziale neuroprotettivo ritardando il tempo al peggioramento della disabilit脿 confermato a 24 settimane (24wCDW). Il farmaco ha inoltre evidenziato riduzioni della perdita di volume talamica e del volume di nuove/ingrandite lesioni T2.
Si tratta del quinto brevetto statunitense per vidofludimus calcium nella sclerosi multipla, parte di una strategia di propriet脿 intellettuale multilivello che comprende brevetti sulla composizione chimica, sui metodi di trattamento e sui regimi posologici.
Immunic (NASDAQ:IMUX) ha recibido una Notice of Allowance de la USPTO para una solicitud de patente que cubre las concentraciones dosis de su principal producto, vidofludimus calcium (IMU-838), para el tratamiento de la esclerosis m煤ltiple progresiva (PMS). La patente abarca concretamente dosis diarias de 10 a 45 mg para tratar la PMS, incluyendo las formas primaria y secundaria progresivas.
La protecci贸n del patente se extender谩 hasta 2041 y llega tras los resultados positivos del ensayo de fase 2 CALLIPER, en el que vidofludimus calcium mostr贸 potencial neuroprotector al retrasar el tiempo hasta el empeoramiento de la discapacidad confirmado a 24 semanas (24wCDW). El f谩rmaco tambi茅n demostr贸 reducciones en la p茅rdida de volumen tal谩mico y en el volumen de nuevas/agrandadas lesiones T2.
Este es el quinto patente en EE. UU. para vidofludimus calcium en esclerosis m煤ltiple, como parte de una estrategia de propiedad intelectual por capas que incluye patentes sobre la composici贸n, m茅todos de tratamiento y reg铆menes de dosificaci贸n.
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Immunic (NASDAQ:IMUX) a re莽u une Notice of Allowance de l'USPTO pour une demande de brevet couvrant les dosages de son principal produit, vidofludimus calcium (IMU-838), pour le traitement de la scl茅rose en plaques progressive (PMS). Le brevet porte sp茅cifiquement sur des doses journali猫res de 10 脿 45 mg pour le traitement de la PMS, y compris les formes progressives primaires et secondaires.
La protection brev茅taire s'茅tendra jusqu'en 2041 et fait suite aux r茅sultats positifs de l'essai de phase 2 CALLIPER, o霉 le vidofludimus calcium a montr茅 un potentiel neuroprotecteur en retardant le d茅lai avant l'aggravation confirm茅e du handicap 脿 24 semaines (24wCDW). Le m茅dicament a 茅galement entra卯n茅 des r茅ductions de la perte de volume thalamique et du volume des nouvelles/茅largies l茅sions T2.
Il s'agit du cinqui猫me brevet am茅ricain pour le vidofludimus calcium dans la scl茅rose en plaques, au sein d'une strat茅gie de propri茅t茅 intellectuelle 脿 plusieurs niveaux incluant des brevets sur la composition, les m茅thodes de traitement et les sch茅mas posologiques.
Immunic (NASDAQ:IMUX) hat von der USPTO eine Notice of Allowance f眉r eine Patentanmeldung erhalten, die Dosierungen seines f眉hrenden Wirkstoffs vidofludimus calcium (IMU-838) zur Behandlung der progredienten Multiplen Sklerose (PMS) abdeckt. Das Patent bezieht sich konkret auf t盲gliche Dosen von 10鈥�45 mg zur Behandlung von PMS, einschlie脽lich prim盲r und sekund盲r progredienter Formen.
Der Patentschutz gilt bis 2041 und folgt auf positive Ergebnisse der Phase-2-Studie CALLIPER, in der vidofludimus calcium neuroprotektives Potenzial zeigte, indem die Zeit bis zur 24-w枚chigen best盲tigten Verschlechterung der Behinderung (24wCDW) verz枚gert wurde. Das Medikament zeigte au脽erdem Verringerungen des thalamischen Volumenverlusts und des Volumens neuer/verdickter T2-L盲sionen.
Dies ist das f眉nfte US-Patent f眉r vidofludimus calcium bei Multipler Sklerose und Teil einer mehrschichtigen IP-Strategie, die Patente auf Wirkstoffzusammensetzung, Behandlungsverfahren und Dosierungsschemata umfasst.
- Patent protection secured until 2041 with potential for extension
- Positive Phase 2 CALLIPER trial results showing neuroprotective potential
- 24-week confirmed disability worsening (24wCDW) endpoint could support pivotal Phase 3 trial
- Multiple layers of patent protection across various jurisdictions
- Additional regulatory discussions needed before proceeding to Phase 3 trials
Insights
Immunic secures vital patent protection for MS drug dosing through 2041, strengthening commercial potential after positive Phase 2 results.
Immunic's new patent allowance represents a significant intellectual property milestone for vidofludimus calcium, their lead candidate for progressive multiple sclerosis (PMS). This fifth U.S. patent specifically covers dosage strengths (10-45mg daily) for treating both primary and secondary progressive MS forms - precisely the dosing range likely needed for commercialization based on their clinical trials.
The timing is strategically optimal, coming after positive Phase 2 CALLIPER trial results showed the drug's ability to delay confirmed disability worsening, which is a critical regulatory endpoint for MS therapies. This patent extends protection until 2041, with potential for further extensions, creating a substantial exclusivity window that significantly enhances the drug's commercial value proposition.
What's particularly impressive is Immunic's multi-layered IP strategy. Beyond this dosage patent, they've secured protection for the calcium salt formulation itself, specific polymorphs, manufacturing methods, and various treatment applications. They also have pending applications that could extend protection to 2044 for neurodegenerative applications. Combined with regulatory data exclusivity for a new chemical entity, this creates formidable barriers to generic competition.
For investors, this patent allowance substantially de-risks the commercial pathway for vidofludimus calcium in progressive MS, a condition with significant unmet needs and market potential. The robust IP portfolio means that even if the company pursues partnerships or licensing, they're negotiating from a position of strength with long-term exclusivity rights secured.
鈥� Fifth
鈥� Comprehensive Intellectual Property Strategy Secures Protection Into 2041 in the
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
"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
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: .
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
Contact Information
Immunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
[email protected]
US IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
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KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
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FAQ
What patent did Immunic (IMUX) receive for vidofludimus calcium in September 2025?
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