BioNxt Solutions Inc. reported an update on its commercialization plan for its transdermal Rotigotine patch for the treatment of Parkinson's disease. The Company's Rotigotine patch is based on the TDS platform technology developed by its wholly owned German subsidiary, Vektor Pharma TF GmbH. On October 18, 2022, BioNxt announced excellent in-vitro/ex-vivo results for its PD treatment based on comparative drug absorption analysis between the Company's new optimized transdermal formulation and the global name brand Rotigotine product.

With these results in hand, the Company is preparing for a human clinical pilot study in second quarter 2023. The comparative study is designed as a randomized, crossover, two-period, single dose pilot study to assess the relative bioavailability, skin adhesion and skin tolerance of BioNxt's new formulation compared to the name brand product. The study will be carried out in Europe in accordance with Good Clinical Practice (GCP) and the European Medical Agency (EMA) Guideline on quality of transdermal patches.

In parallel to its clinical study, BioNxt is planning the development of commercial manufacturing capabilities at its German drug development facility. This will include EU GMP-approved manufacturing and packaging equipment as well as a modified manufacturing line capable of producing pivotal trial materials compliant with commercial regulatory approval applications and final commercial products (transdermal and oral dissolvable). The Company expects to make further announcements regarding its commercialization capabilities over the coming months.

Rotigotine is a non-ergoline dopamine agonist approved for the treatment of Parkinson's disease and restless legs syndrome (RLS) in Europe and the United States. The active pharmaceutical ingredient is not well absorbed via oral delivery and is formulated as a once-daily TDS patch to increase bioavailability and provide a slow and steady supply of the drug over the course of 24 hours. BioNxt's Rotigotine transdermal product is a single product based on its 100% owned platform technology which represents a scalable opportunity for additional TDS drug development and manufacturing programs.