BioNxt Solutions has announced two key milestones in the expansion and protection of its proprietary drug delivery platform targeting neurological autoimmune disorders.
Firstly, the company has formally initiated the prioritised examination process for its US patent application for BNT23001, a novel sublingual thin-film drug delivery platform for multiple sclerosis (MS), under the United States Patent and Trademark Office’s (USPTO) Track One Program.
Simultaneously, BioNxt has received acceptance of core claims for a broad international patent designed as a platform-level umbrella protecting its sublingual thin-film delivery technology across a wide range of diseases, drug compounds, and applications.
Fast-tracked US patent accelerates clinical development milestones
BioNxt is set to pursue USPTO’s Track One Prioritized Examination Program to accelerate patent review for its drug delivery platform BNT23001.
Once accepted, this programme enables final patent disposition within 12 months, with most applicants receiving a first Office Action in approximately two months and a final decision in under seven months.
For BioNxt, this fast-tracks status represents a strategic opportunity to secure near-term US patent protection and strengthen its IP position ahead of pivotal bioequivalence studies and commercial partnering discussions.
Rapid approval for revolutionary drug delivery
BioNxt is advancing BNT23001 for relapsing-remitting MS (RRMS) and primary progressive MS (PPMS), as well as generalised myasthenia gravis (GMG).
Merck KGaA is currently conducting a Phase 3 clinical trial to evaluate cladribine capsules in GMG (ClinicalTrials.gov: NCT06463587), further validating the therapeutic relevance of the compound beyond MS.
Through this, BioNxt aims to confirm that its sublingual thin film offers superbioavailability in comparison to Merck’s MAVENCLAD® tablets, which generated more than $1bn in sales in 2023.
A preclinical pharmacokinetic (PK) study in pigs, an established translational model for oral and sublingual absorption, will be initiated in the near term to provide critical bioavailability data to support regulatory positioning and formulation optimisation.
A platform-level umbrella for autoimmune neurology
In parallel to its US patent fast-tracking, BioNxt has achieved a major intellectual property milestone with the acceptance of core claims in its broad international umbrella patent protecting its thin-film drug delivery platform.
This foundational patent is not limited to BNT23001, but instead provides platform-level protection for a wide range of drug compounds, therapeutic indications, administration methods, and manufacturing processes.
Key disease targets include relapsing-remitting and primary progressive multiple sclerosis, generalised myasthenia gravis, neuromyelitis optica spectrum disorders (NMOSD), autoimmune encephalitis, central nervous system (CNS) vasculitis, optic neuritis, Hashimoto’s encephalopathy, cerebral lupus, and Sjögren’s syndrome.
BioNxt’s drug delivery platform targets unmet needs of global markets
More than 2.8 million people are living with multiple sclerosis (MS) globally, including nearly 1 million in the United States alone, according to the National Multiple Sclerosis Society.
Meanwhile, generalised myasthenia gravis affects an estimated 700,000 people globally and remains an area of unmet therapeutic need.
BioNxt estimates that its initial target indications, MS and GMG, represent a combined total addressable market of $42-46 billion by 2032, based on internal analysis and third-party forecasting.
The company expects to report results from its preclinical PK study later this year, supporting its regulatory strategy and partnership discussions.
