BioNxt Advances Sublingual Cladribine Program for MS

BioNxt Solutions Inc., a Vancouver-based bioscience innovator, announced a key advancement in its sublingual cladribine program for multiple sclerosis (MS). The company has received the active pharmaceutical ingredient (API) for BNT23001, its lead product candidate. This allows the start of clinical batch manufacturing with European partner Gen-Plus GmbH & Co KG in Munich, Germany.

BNT23001 is a sublingual thin-film formulation, designed to enhance patient compliance by offering a rapidly dissolving alternative to oral tablets. This is especially beneficial for MS patients with dysphagia. Preclinical studies show high absorption rates and bioequivalence with no adverse effects, supporting the move to human studies.

BioNxt is also securing intellectual property rights for BNT23001 in key markets. The anticipated patent grants are expected by mid-2025, aligning with the company's plans for global patient access.