BioNxt's Sublingual Cladribine Program for MS Ready for Next Phase
BioNxt Solutions (OTC:BNXTF) has reached a significant milestone in its multiple sclerosis (MS) drug development program with the receipt of the active pharmaceutical ingredient (API) for BNT23001, their proprietary sublingual thin-film formulation of cladribine.
The company will now proceed with clinical batch manufacturing through their European partner, Gen-Plus GmbH & Co KG, in preparation for a human bioequivalence study planned for H2 2025. BNT23001 is designed as an alternative to traditional oral cladribine tablets like Mavenclad庐, offering a rapidly dissolving sublingual film particularly beneficial for MS patients with swallowing difficulties.
Preclinical studies have shown promising results with high absorption rates and bioequivalence to existing oral therapies, without toxic effects. The company is also advancing patent applications in key markets including Europe, the US, and Canada.
BioNxt Solutions (OTC:BNXTF) ha raggiunto un traguardo importante nel suo programma di sviluppo di farmaci per la sclerosi multipla (SM) con la ricezione del principio attivo farmaceutico (API) per BNT23001, la loro formulazione proprietaria a film sottolinguale di cladribina.
L'azienda proceder脿 ora alla produzione del lotto clinico tramite il partner europeo Gen-Plus GmbH & Co KG, in preparazione a uno studio di bioequivalenza umana previsto per la seconda met脿 del 2025. BNT23001 猫 concepito come alternativa alle tradizionali compresse orali di cladribina come Mavenclad庐, offrendo un film sottolinguale a rapido scioglimento, particolarmente vantaggioso per i pazienti con SM che hanno difficolt脿 a deglutire.
Gli studi preclinici hanno mostrato risultati promettenti con elevati tassi di assorbimento e bioequivalenza rispetto alle terapie orali esistenti, senza effetti tossici. L'azienda sta inoltre avanzando con le domande di brevetto nei mercati chiave, tra cui Europa, Stati Uniti e Canada.
BioNxt Solutions (OTC:BNXTF) ha alcanzado un hito significativo en su programa de desarrollo de medicamentos para la esclerosis m煤ltiple (EM) con la recepci贸n del ingrediente farmac茅utico activo (API) para BNT23001, su formulaci贸n propietaria de pel铆cula sublingual de cladribina.
La compa帽铆a proceder谩 ahora con la fabricaci贸n del lote cl铆nico a trav茅s de su socio europeo, Gen-Plus GmbH & Co KG, en preparaci贸n para un estudio de bioequivalencia humana planeado para la segunda mitad de 2025. BNT23001 est谩 dise帽ado como una alternativa a las tabletas orales tradicionales de cladribina como Mavenclad庐, ofreciendo una pel铆cula sublingual de r谩pida disoluci贸n especialmente beneficiosa para pacientes con EM que tienen dificultades para tragar.
Los estudios precl铆nicos han mostrado resultados prometedores con altas tasas de absorci贸n y bioequivalencia a las terapias orales existentes, sin efectos t贸xicos. La compa帽铆a tambi茅n est谩 avanzando en las solicitudes de patente en mercados clave, incluyendo Europa, EE.UU. y Canad谩.
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須岇偓電� 鞙犽熃 韺岉姼雱堨澑 Gen-Plus GmbH & Co KG毳� 韱淀暣 鞛勳儊 氚办箻 鞝滌“毳� 歆勴枆頃� 鞓堨爼鞚措┌, 2025雲� 頃橂皹旮办棎 瓿勴殟霅� 鞚戈皠 靸濍頃欖爜 霃欕摫靹� 鞐瓣惮毳� 欷�牍勴晿瓿� 鞛堨姷雼堧嫟. BNT23001鞚� Mavenclad庐鞕� 臧欖潃 鞝勴喌鞝侅澑 瓴疥惮鞖� 韥措澕霌滊Μ牍� 鞝曥牅鞚� 雽�鞎堨溂搿� 靹り硠霅橃棃鞙茧┌, 靷柬偆旮� 鞏措牑鞖� MS 頇橃瀽鞐愱矊 韸鬼瀳 鞙犾毄頃� 牍犽ゴ瓴� 鞖╉暣霅橂姅 靹ろ晿 氚曤鞚� 鞝滉车頃╇媹雼�.
鞝勳瀯靸� 鞐瓣惮鞐愳劀 雴掛潃 頋§垬鞙臣 旮办〈 瓴疥惮 旃橂鞝滌檧鞚� 靸濍頃欖爜 霃欕摫靹�鞚� 鞛呾霅橃棃鞙茧┌, 霃呾劚 須臣電� 鞐嗢棃鞀惦媹雼�. 須岇偓電� 霕愴暅 鞙犽熃, 氙戈淡, 旌愲倶雼� 霌� 欤检殧 鞁滌灔鞐愳劀 韸鬼棃 於滌洂鞚� 歆勴枆 欷戩瀰雼堧嫟.
BioNxt Solutions (OTC:BNXTF) a atteint une 茅tape importante dans son programme de d茅veloppement de m茅dicaments pour la scl茅rose en plaques (SEP) avec la r茅ception de l'ingr茅dient pharmaceutique actif (API) pour BNT23001, leur formulation propri茅taire de film sublingual de cladribine.
L'entreprise va maintenant proc茅der 脿 la fabrication du lot clinique via son partenaire europ茅en, Gen-Plus GmbH & Co KG, en pr茅paration d'une 茅tude de bio茅quivalence humaine pr茅vue pour le second semestre 2025. BNT23001 est con莽u comme une alternative aux comprim茅s oraux traditionnels de cladribine tels que Mavenclad庐, offrant un film sublingual 脿 dissolution rapide particuli猫rement b茅n茅fique pour les patients SEP ayant des difficult茅s 脿 avaler.
Les 茅tudes pr茅cliniques ont montr茅 des r茅sultats prometteurs avec des taux d'absorption 茅lev茅s et une bio茅quivalence aux th茅rapies orales existantes, sans effets toxiques. L'entreprise fait 茅galement progresser ses demandes de brevet sur des march茅s cl茅s, notamment en Europe, aux 脡tats-Unis et au Canada.
BioNxt Solutions (OTC:BNXTF) hat einen bedeutenden Meilenstein in seinem Entwicklungsprogramm f眉r Multiple-Sklerose-Medikamente erreicht, indem der Wirkstoff (API) f眉r BNT23001, ihre propriet盲re sublinguale D眉nnfilmformulierung von Cladribin, erhalten wurde.
Das Unternehmen wird nun mit der Herstellung klinischer Chargen 眉ber seinen europ盲ischen Partner Gen-Plus GmbH & Co KG fortfahren, um sich auf eine f眉r die zweite H盲lfte 2025 geplante humanbiologische 脛quivalenzstudie vorzubereiten. BNT23001 ist als Alternative zu herk枚mmlichen oralen Cladribin-Tabletten wie Mavenclad庐 konzipiert und bietet einen schnell l枚slichen sublingualen Film, der besonders vorteilhaft f眉r MS-Patienten mit Schluckbeschwerden ist.
Pr盲klinische Studien zeigten vielversprechende Ergebnisse mit hohen Absorptionsraten und Bio盲quivalenz zu bestehenden oralen Therapien, ohne toxische Effekte. Das Unternehmen treibt au脽erdem Patentanmeldungen in wichtigen M盲rkten wie Europa, den USA und Kanada voran.
- Successful completion of preclinical studies showing high absorption rates and bioequivalence
- Patent applications in progress for key markets (Europe, US, Canada)
- Ready to commence clinical batch manufacturing for human trials
- Product addresses specific MS patient needs, particularly those with dysphagia
- Human trials yet to begin
- Patent grants still pending
- Potential competition from established treatments like Mavenclad
VANCOUVER, BC / / July 7, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC:XPHYF)(FSE:4XT), a bioscience innovator specializing in advanced drug delivery systems, is pleased to announce the receipt of the active pharmaceutical ingredient (API) for its lead product candidate, BNT23001. This proprietary sublingual thin-film formulation of cladribine is being developed for the treatment of multiple sclerosis (MS).
The delivery of the cladribine API enables the commencement of clinical batch manufacturing in collaboration with BioNxt's European contract research and development partner, Gen-Plus GmbH & Co KG, based in Munich, Germany. This milestone supports the company's plan to initiate a human bioequivalence study in the second half of 2025.
BNT23001 is designed to offer a patient-friendly alternative to traditional oral cladribine tablets, such as Mavenclad庐, by providing a rapidly dissolving sublingual film. This delivery method aims to enhance patient compliance, particularly for individuals with MS who experience dysphagia, a common symptom affecting the ability to swallow.
Preclinical studies have demonstrated that BNT23001 achieves high absorption rates and bioequivalence to existing oral therapies, with no adverse toxic effects observed. These findings support the progression to human bioequivalence studies.
BioNxt has also made significant strides in securing intellectual property rights for BNT23001. The company has initiated patent nationalization processes in key jurisdictions, including Europe, the United States, and Canada, with patent grants anticipated by mid-2025.
"The receipt of the cladribine API is a pivotal step forward in our mission to develop innovative, patient-centric therapies for MS," said Hugh Rogers, CEO of BioNxt Solutions. "We are committed to advancing BNT23001 through clinical development and bringing this novel treatment option to patients worldwide."
About BioNxt Solutions Inc.
BioNxt Solutions Inc. is a bioscience innovator focused on next鈥恎eneration drug delivery technologies, diagnostic screening systems, and active pharmaceutical ingredient development. The Company's proprietary platforms-Sublingual (Thin鈥怓ilm), Transdermal (Skin Patch), and Oral (Enteric鈥怌oated Tablets)-target key therapeutic areas, including autoimmune diseases, neurological disorders, and longevity.
With research and development operations in North America and Europe, BioNxt is advancing regulatory approvals and commercialization efforts, primarily focused on European markets. BioNxt is committed to improving healthcare by delivering precise, patient鈥恈entric solutions that enhance treatment outcomes worldwide.
BioNxt is listed on the Canadian Securities Exchange: BNXT, OTC Markets: BNXTF and trades in Germany under WKN: A3D1K3. To learn more about BioNxt, please visit .
Investor Relations & Media Contact
Hugh Rogers, Co鈥怓ounder, CEO and Director
Email: [email protected]
Phone: +1 778.598.2698
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Cautionary Statement Regarding "Forward鈥怢ooking" Information
This news release includes certain statements that may be deemed "forward-looking statements". All statements in this release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Forward-looking information in this news release includes the anticipated filing date of the Annual Filings. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include regulatory actions, market prices, and continued availability of capital and financing, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company's management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change.
SOURCE: BioNxt Solutions Inc.
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