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Highlights
- BioNxt files new international patents for sublingual drug delivery technologies targeting autoimmune neurodegenerative diseases.
- Company’s proprietary sublingual formulation of Cladribine shows promise in treating Multiple Sclerosis (MS) and Myasthenia Gravis (MG).
- Strategic milestones set for 2025, including clinical trials and partnership development to advance therapies.
BioNxt Solutions Inc. (CSE: BNXT) (OTC PINK: BNXTF) (FSE: BXT), a leading innovator in bioscience and advanced drug delivery systems, is excited to announce the expansion of its intellectual property (IP) portfolio with the filing of new international patents for its proprietary sublingual drug delivery technologies. The filings focus on formulations targeting autoimmune neurodegenerative diseases such as Multiple Sclerosis (MS) and Myasthenia Gravis (MG). This development follows the positive International Preliminary Report on Patentability (IPRP) issued by the European Patent Office (EPO) in September 2024, which marks a key milestone in the company's efforts to secure patent protection in global markets.
Advancing Therapeutic Solutions for Autoimmune Diseases
The patents encompass BioNxt’s novel sublingual formulations of anticancer drugs repurposed for MS treatment. These new formulations include Cladribine, which has demonstrated promising preclinical results, showcasing high absorption rates and bioequivalence to existing oral therapies. The sublingual delivery method offers significant advantages, especially for MS patients who struggle with difficulty swallowing traditional oral medications. BioNxt’s delivery platform enables rapid absorption, providing a potentially more efficient and patient-friendly treatment option.
“Our sublingual delivery platform provides a compelling advantage for patients with autoimmune neurodegenerative diseases, offering both ease of use and rapid absorption,” said Hugh Rogers, CEO of BioNxt Solutions. “Securing strong intellectual property rights across key markets is a critical component of our strategy to deliver innovative therapies to those affected by conditions like MS and Myasthenia Gravis.”
Lead Product: BNT23001 for Multiple Sclerosis
BioNxt’s lead product, BNT23001, is a proprietary sublingual thin-film formulation of Cladribine designed to treat MS. In preclinical studies, BNT23001 has demonstrated favorable pharmacokinetic properties and strong bioequivalence to the oral formulation of Cladribine, with high absorption rates that suggest improved efficacy. With clinical trials slated to begin in 2025, subject to regulatory approval, BNT23001 has the potential to provide MS patients with an innovative, easier-to-administer treatment alternative.
In addition to MS, BioNxt is advancing its sublingual Cladribine formulations for Myasthenia Gravis (MG), a condition characterized by muscle weakness. The global MG market is expected to reach USD 6.7 billion by 2032, presenting a significant opportunity for BioNxt’s novel therapies. By repurposing Cladribine for MG treatment, BioNxt aims to address a pressing unmet need in the MG patient population.
Strategic Vision for 2025 and Key Milestones
Looking ahead to 2025, BioNxt has outlined a series of critical milestones to advance its sublingual drug delivery platform and bring its therapies closer to market. These milestones include:
- Initiation of Clinical Trials: BioNxt will launch bioequivalence trials for BNT23001, its sublingual Cladribine formulation for Multiple Sclerosis.
- Regulatory Submissions: The Company will prepare and submit clinical trial applications (CTAs) in key markets to support ongoing clinical activities.
- Partnership Development: BioNxt plans to engage in strategic partnerships with pharmaceutical and biotech companies to accelerate the development and commercialization of its therapies.
- Pipeline Expansion: The Company will continue to explore additional applications for its sublingual delivery technology, aiming to expand its treatment portfolio for autoimmune and neurodegenerative diseases.
- Investor and Industry Engagement: BioNxt will participate in key industry conferences and meetings with investors to foster collaboration and secure funding for its initiatives.
