BioNxt Solutions Prepares for Human Bioequivalence Study For MS
BioNxt Solutions (CSE:BNXT, OTC:BNXTF) is advancing preparations for a human bioequivalence study of its lead Multiple Sclerosis treatment, BNT23001. The product is a proprietary sublingual thin-film formulation of Cladribine designed to treat MS.
The company has acquired the necessary Cladribine active pharmaceutical ingredient to complete technology transfer with Gen-Plus, its European Contract Research and Development Organization in Munich, Germany. The upcoming bioequivalence study is expected to be completed in under 30 days once initiated.
Preclinical studies have shown high absorption rates and bioequivalence compared to existing oral tablet therapies. BNT23001's sublingual thin-film format offers key advantages including convenient administration, rapid absorption through sublingual mucosa, and improved patient compliance.
BioNxt Solutions (CSE:BNXT, OTC:BNXTF) sta avanzando nella preparazione di uno studio di bioequivalenza umano per il suo principale trattamento per la sclerosi multipla, BNT23001. Il prodotto è una formulazione proprietaria di film sottolinguale di Cladribina, progettata per trattare la SM.
L'azienda ha acquisito il principio attivo di Cladribina necessario per completare il trasferimento tecnologico con Gen-Plus, la sua organizzazione europea di ricerca e sviluppo a contratto con sede a Monaco di Baviera, Germania. Lo studio di bioequivalenza previsto dovrebbe essere completato in meno di 30 giorni dal suo avvio.
Gli studi preclinici hanno dimostrato alte percentuali di assorbimento e bioequivalenza rispetto alle terapie orali esistenti in compresse. Il formato a film sottolinguale di BNT23001 offre vantaggi chiave, tra cui una somministrazione comoda, un rapido assorbimento attraverso la mucosa sottolinguale e una migliore compliance del paziente.
BioNxt Solutions (CSE:BNXT, OTC:BNXTF) está avanzando en los preparativos para un estudio de bioequivalencia humana de su tratamiento principal para la esclerosis múltiple, BNT23001. El producto es una formulación propietaria en película delgada sublingual de Cladribina diseñada para tratar la EM.
La compañía ha adquirido el principio activo de Cladribina necesario para completar la transferencia tecnológica con Gen-Plus, su organización europea de investigación y desarrollo por contrato ubicada en Múnich, Alemania. Se espera que el próximo estudio de bioequivalencia se complete en menos de 30 días una vez iniciado.
Los estudios preclínicos han mostrado altas tasas de absorción y bioequivalencia en comparación con las terapias orales en tabletas existentes. El formato de película delgada sublingual de BNT23001 ofrece ventajas clave, incluyendo una administración conveniente, rápida absorción a través de la mucosa sublingual y una mejor adherencia del paciente.
BioNxt Solutions (CSE:BNXT, OTC:BNXTF)는 주요 다발성 경화증 치료제인 BNT23001의 인체 생물학적 동등성 시험 준비를 진행하고 있습니다. 이 제품은 다발성 경화증 치료를 위해 설계된 클라드리빈의 독점 설하 박막 제형입니다.
회사는 독일 뮌헨에 위치한 유럽 계약 연구개발 기관인 Gen-Plus와의 기술 이전을 완료하기 위해 필요한 클라드리빈 활성 의약품 원료를 확보했습니다. 예정된 생물학적 동등성 시험은 시작 후 30일 이내에 완료될 것으로 예상됩니다.
전임상 연구 결과 기존 경구 정제 치료제와 비교해 높은 흡수율과 생물학적 동등성이 확인되었습니다. BNT23001의 설하 박막 제형은 편리한 투여, 설하 점막을 통한 빠른 흡수, 환자의 복약 순응도 향상 등 주요 이점을 제공합니다.
BioNxt Solutions (CSE:BNXT, OTC:BNXTF) progresse dans les préparatifs d'une étude d'équivalence biologique humaine de son traitement principal contre la sclérose en plaques, BNT23001. Le produit est une formulation propriétaire en film fin sublingual de Cladribine conçue pour traiter la SEP.
L'entreprise a acquis le principe actif de Cladribine nécessaire pour finaliser le transfert technologique avec Gen-Plus, son organisation européenne de recherche et développement sous contrat basée à Munich, en Allemagne. L'étude d'équivalence biologique à venir devrait être terminée en moins de 30 jours une fois lancée.
Les études précliniques ont démontré des taux d'absorption élevés et une équivalence biologique par rapport aux thérapies orales existantes sous forme de comprimés. Le format en film fin sublingual de BNT23001 offre des avantages clés, notamment une administration pratique, une absorption rapide via la muqueuse sublinguale et une meilleure observance du patient.
BioNxt Solutions (CSE:BNXT, OTC:BNXTF) bereitet eine Human-Bioäquivalenzstudie für seine führende Multiple-Sklerose-Behandlung, BNT23001, vor. Das Produkt ist eine proprietäre sublinguale Dünnfilmformulierung von Cladribin, die zur Behandlung von MS entwickelt wurde.
Das Unternehmen hat den notwendigen aktiven pharmazeutischen Wirkstoff Cladribin erworben, um den Technologietransfer mit Gen-Plus, seiner europäischen Auftragsforschungs- und Entwicklungsorganisation in München, Deutschland, abzuschließen. Die bevorstehende Bioäquivalenzstudie soll innerhalb von weniger als 30 Tagen nach Beginn abgeschlossen sein.
Präklinische Studien zeigten hohe Absorptionsraten und Bioäquivalenz im Vergleich zu bestehenden oralen Tablettentherapien. Das sublinguale Dünnfilmformat von BNT23001 bietet wesentliche Vorteile wie bequeme Verabreichung, schnelle Absorption durch die sublinguale Schleimhaut und verbesserte Patientencompliance.
- Preclinical studies show high absorption rates and bioequivalence to existing treatments
- Study completion expected in under 30 days once started
- Key materials (Cladribine API) already acquired for technology transfer
- Bioequivalence study has not yet commenced
- Currently still in preclinical stage without human trial data
VANCOUVER, BC / ACCESS Newswire / April 23, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT), a bioscience innovator specializing in advanced drug delivery systems, is pleased to report advanced preparation for its human bioequivalence study for its lead Multiple Sclerosis (MS) treatment.
BioNxt's lead product, BNT23001, is a proprietary sublingual thin-film formulation of Cladribine for the treatment of MS. Preclinical studies, as reported in internal research data and third-party evaluations, have demonstrated high absorption rates and bioequivalence compared to existing oral tablet therapies. The Company has purchased Cladribine active pharmaceutical ingredient which is necessary to complete the technology transfer process with Gen-Plus, its European Contract Research and Development Organization (CRDO), in Munich, Germany. Once commenced, the bioequivalence study is relatively short, scheduled for less than 30 days from start to finish.
The Company plans to make further updates in the coming weeks regarding its bioequivalent study preparation and scheduling, as well integration of its research and development operations with Gen-Plus.
BNT23001 offers a novel approach to MS management by addressing limitations in traditional oral therapies. Its sublingual thin-film format provides:
Convenience: Easy-to-use and portable, ideal for patients with difficulty swallowing or active lifestyles.
Rapid Absorption: Direct delivery through the sublingual mucosa for faster therapeutic action.
Improved Compliance: A patient-friendly alternative designed to enhance adherence to prescribed regimens.
By delivering these advantages, BNT23001 aligns with BioNxt's mission to improve outcomes for patients living with chronic diseases like MS.
About BioNxt Solutions Inc.
BioNxt Solutions Inc. is a bioscience innovator focused on next-generation drug delivery technologies, diagnostic screening systems, and active pharmaceutical ingredient development. The Company's proprietary platforms-Sublingual (Thin-Film), Transdermal (Skin Patch), and Oral (Enteric-Coated 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-centric 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 www.bionxt.com.
Investor Relations & Media Contact
Hugh Rogers, Co-Founder, CEO and Director
Email: investor.relations@bionxt.com
Phone: +1 778.598.2698
Web: www.bionxt.com
LinkedIn: https://www.linkedin.com/company/bionxt-solutions
Instagram: https://www.instagram.com/bionxt
Cautionary Statement Regarding "Forward-Looking" Information
This press release contains forward-looking statements within the meaning of applicable securities laws, including statements regarding the development, testing, regulatory approval, and commercialization of BioNxt's sublingual drug products, as well as projected milestones, anticipated partnerships, and potential market opportunities. Forward-looking statements are inherently subject to significant risks, uncertainties, and assumptions, many of which are beyond BioNxt's control. Factors that could cause actual results to differ materially include, but are not limited to, delays in regulatory approvals, negative outcomes from clinical trials, changes in market demand, fluctuations in funding availability, or disruptions in supply chains. Readers are cautioned not to place undue reliance on these forward-looking statements, as actual results may differ materially from those expressed or implied. BioNxt undertakes no obligation to update or revise forward-looking statements, except as required by law. Factors that could cause actual results to differ materially from those projected include changes in market demand, regulatory developments, delays in clinical trials, fluctuations in financing availability, supply chain disruptions, and unforeseen competitive pressures.
SOURCE: BioNxt Solutions Inc.
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FAQ
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