BioNxt Solutions Reports Progress on BNT23001 Development for Multiple Sclerosis Treatment
BioNxt Solutions has reported significant progress in developing BNT23001, a sublingual thin-film formulation of Cladribine for Multiple Sclerosis treatment. In 2024, the company achieved key milestones including successful preclinical trials showing high absorption rates and bioequivalence to Mavenclad®, transfer of production to GMP-certified manufacturer Gen-Plus GmbH, and favorable patent reports.
For 2025, BioNxt plans to complete GMP manufacturing of clinical trial batches in Q2, submit regulatory filings by mid-year, and launch a pilot clinical study in the second half comparing BNT23001 to Mavenclad®. The product offers advantages including convenient administration, rapid absorption through sublingual delivery, and improved patient compliance.
BioNxt Solutions ha riportato progressi significativi nello sviluppo di BNT23001, una formulazione sottolinguale in film sottile di Cladribina per il trattamento della sclerosi multipla. Nel 2024, l'azienda ha raggiunto traguardi importanti, tra cui prove precliniche di successo che mostrano elevati tassi di assorbimento e bioequivalenza a Mavenclad®, trasferimento della produzione a Gen-Plus GmbH, un produttore certificato GMP, e rapporti di brevetto favorevoli.
Per il 2025, BioNxt prevede di completare la produzione GMP dei lotti per studi clinici nel secondo trimestre, presentare le richieste normative entro la metà dell'anno e avviare uno studio clinico pilota nella seconda metà che confronti BNT23001 con Mavenclad®. Il prodotto offre vantaggi come un'amministrazione conveniente, un rapido assorbimento tramite somministrazione sublinguale e una migliore compliance del paziente.
BioNxt Solutions ha reportado avances significativos en el desarrollo de BNT23001, una formulación sublingual en película delgada de Cladribina para el tratamiento de la esclerosis múltiple. En 2024, la compañía alcanzó hitos clave que incluyen ensayos preclínicos exitosos que muestran altas tasas de absorción y bioequivalencia con Mavenclad®, transferencia de producción a Gen-Plus GmbH, un fabricante certificado por GMP, y reportes de patentes favorables.
Para 2025, BioNxt planea completar la fabricación GMP de lotes para ensayos clínicos en el segundo trimestre, presentar solicitudes regulatorias a mediados de año y lanzar un estudio clínico piloto en la segunda mitad que compare BNT23001 con Mavenclad®. El producto ofrece ventajas como una administración conveniente, rápida absorción a través de la entrega sublingual y una mejor adherencia del paciente.
BioNxt Solutions는 다발성 경화증 치료를 위한 클라드리빈의 경구 투여형 얇은 필름 제형인 BNT23001 개발에서 중요한 진전을 보고했습니다. 2024년 동안 이 회사는 높은 흡수율과 Mavenclad®와의 생물학적 동등성을 보여주는 성공적인 전임상 시험, GMP 인증 제조업체인 Gen-Plus GmbH로의 생산 이전, 유리한 특허 보고서를 포함한 주요 이정표를 달성했습니다.
2025년에는 BioNxt가 2분기에 임상 시험 배치의 GMP 제조를 완료하고, 상반기 중반까지 규제 제출을 하고, 하반기에는 BNT23001과 Mavenclad®를 비교하는 파일럿 임상 연구를 시작할 계획입니다. 이 제품은 편리한 투여, 경구 투여를 통한 빠른 흡수, 환자의 복용 순응도를 개선하는 등의 이점을 제공합니다.
BioNxt Solutions a signalé des progrès significatifs dans le développement de BNT23001, une formulation sous la langue en film mince de Cladribine pour le traitement de la sclérose en plaques. En 2024, la société a atteint des jalons clés, notamment des essais précliniques réussis montrant des taux d'absorption élevés et une bioéquivalence avec Mavenclad®, le transfert de la production à Gen-Plus GmbH, un fabricant certifié GMP, et des rapports de brevet favorables.
Pour 2025, BioNxt prévoit de compléter la fabrication GMP des lots d'essais cliniques au deuxième trimestre, de soumettre les dossiers réglementaires d'ici le milieu de l'année et de lancer une étude clinique pilote dans la seconde moitié de l'année comparant BNT23001 à Mavenclad®. Le produit offre des avantages tels qu'une administration pratique, une absorption rapide grâce à une administration sublinguale et une meilleure conformité du patient.
BioNxt Solutions hat erhebliche Fortschritte bei der Entwicklung von BNT23001, einer sublingualen Dünnfilmformulierung von Cladribin zur Behandlung von Multipler Sklerose, berichtet. Im Jahr 2024 erreichte das Unternehmen wichtige Meilensteine, darunter erfolgreiche präklinische Studien mit hohen Absorptionsraten und Bioäquivalenz zu Mavenclad®, den Transfer der Produktion zu dem GMP-zertifizierten Hersteller Gen-Plus GmbH und positive Patentschriften.
Für 2025 plant BioNxt, die GMP-Herstellung von klinischen Prüfungsbatches im zweiten Quartal abzuschließen, regulatorische Anmeldungen bis zur Jahresmitte einzureichen und in der zweiten Jahreshälfte eine Pilotstudie zu starten, die BNT23001 mit Mavenclad® vergleicht. Das Produkt bietet Vorteile wie eine bequeme Verabreichung, schnelle Absorption durch sublinguale Abgabe und verbesserte Patientencompliance.
- Successful preclinical trials demonstrating high absorption rates and bioequivalence
- Production process successfully transferred to GMP-certified manufacturer
- Favorable International Preliminary Report on Patentability (IPRP)
- Patent nationalization initiated in major markets (US, Europe, Canada)
- Clinical trials yet to begin, with first human studies planned for late 2025
- Regulatory approvals still pending
- Product commercialization timeline uncertain
VANCOUVER, BC / ACCESSWIRE / December 9, 2024 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT), a bioscience company specializing in advanced drug delivery systems, has achieved key milestones in the development of BNT23001, its proprietary sublingual thin-film (OFD) formulation of Cladribine for the treatment of Multiple Sclerosis (MS). These achievements in 2024 lay the groundwork for clinical trials and regulatory submissions in 2025, reinforcing BioNxt's commitment to advancing patient-centric therapeutic solutions.
2024 Milestones: Establishing a Strong Foundation for Cladribine Thin-Film Development
Preclinical Success: BNT23001 demonstrated high absorption rates of Cladribine through sublingual delivery in pharmacokinetic (PK) studies conducted in animal models. These studies confirmed the product's bioequivalence to the originator therapy, Mavenclad®, and validated the thin-film's rapid absorption and safety profile. Toxicity studies further demonstrated no adverse local effects, highlighting the viability of the sublingual delivery approach.
Advancements in Manufacturing: BioNxt successfully transferred the BNT23001 production process to its GMP-certified manufacturing partner, Gen-Plus GmbH & Co KG in Munich (Germany), ensuring readiness for clinical batch production. This milestone supports the Company's plan to initiate clinical trials in 2025 with reliable, high-quality product supply.
Strengthened Intellectual Property Position: A favorable International Preliminary Report on Patentability (IPRP) confirmed BNT23001's novelty, inventive step, and industrial applicability, underscoring its unique value in MS treatment. The Company has initiated patent nationalization in major jurisdictions, including Europe, the United States, and Canada, with patent grants anticipated in several regions by mid-2025.
2025 Roadmap: Advancing BNT23001 into Clinical Trials
Manufacturing Clinical Batches: BioNxt will complete GMP manufacturing and Qualified Person (QP) release of clinical trial batches in the second quarter of 2025. This step is critical for the successful initiation of human studies.
Regulatory Filings and Approvals: The Company plans to submit the Investigational Medicinal Product Dossier (IMPD) to European regulatory authorities by mid-2025, paving the way for clinical trial approval. These regulatory submissions will include data from preclinical studies and stability assessments conducted at the manufacturing site.
Clinical Study to Validate Performance: BioNxt aims to launch a pilot clinical study in the latter half of 2025. This trial will compare the efficacy, bioavailability, and safety of BNT23001 to Mavenclad®, the originator tablet product, positioning the thin-film formulation as a patient-friendly alternative.
Ongoing Patent Protection: In addition to continuing the patent nationalization process, BioNxt expects granted patents in key regions to strengthen its intellectual property portfolio and provide competitive advantages as the product moves toward commercialization.
BNT23001: Advancing Toward Clinical Validation for MS Treatment
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: +1 780-818-6422
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 BNT23001, as well as projected milestones for 2025. These statements are based on current expectations and assumptions but involve risks and uncertainties that could cause actual results to differ materially. These risks include clinical trial outcomes, regulatory delays, manufacturing challenges, intellectual property issues, market competition, and changes in laws or market conditions. The Company undertakes no obligation to update or revise forward-looking statements, except as required by law. For more information, refer to the "Risk Factors" section of the Company's filings at www.sedarplus.ca.
Trademarks: Mavenclad® is a registered trademark of EMD Serono, Inc. BioNxt Solutions Inc. is not affiliated with or endorsed by EMD Serono.
SOURCE: BioNxt Solutions Inc.
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FAQ
What are the key milestones achieved by BioNxt (BNXTF) in developing BNT23001 during 2024?
When will BioNxt (BNXTF) begin clinical trials for BNT23001?
What advantages does BioNxt's (BNXTF) BNT23001 offer compared to existing MS treatments?
