May 9, 2022 in Drug Delivery, Press Releases

XPhyto reports product developments on platform-based Rotigotine transdermal patch for Parkinson’s disease

Vancouver, Canada, and Uttenweiler, Germany (May 9, 2022) – XPhyto Therapeutics Corp. (CSE:XPHY / OTC:XPHYF / FSE:4XT) (“XPhyto” or the “Company”) is pleased to provide a product development report on its Rotigotine transdermal (“TDS”) patch, including results of its recent human cadaver skin permeation study, first announced April 4, 2022. The Company’s Rotigotine patch is based on the TDS platform technology developed by its wholly owned German subsidiary, Vektor Pharma TF GmbH (“Vektor”).

On May 13, 2021, XPhyto announced successful completion of a European-based human bioavailability study for its Rotigotine TDS product. The comparative study was carried out over an approximately two-week period as an open label, randomized, crossover, two-period, two-sequence, single dose pilot study to assess the relative bioavailability of its product compared to the name brand product.

As the Company advances its Rotigotine TDS product towards commercialization, Vektor is currently focused on formula optimization, a process which includes the recently completed human cadaver skin permeation study. This study was carried out at Vektor’s EU GMP laboratory and manufacturing facility in Baden-Württemberg, Germany, to compare Rotigotine absorption between two potential drug formulations and the name brand product. Results of the study were positive with both new formulas demonstrating absorption within the generic drug formulation target range (+/-20%) in all three cadaver skin samples.

The Company will continue formula optimization work with an emphasis on the manufacturing and production processes. The Company plans to reproduce the human cadaver skin permeation study prior to finalizing the formula and manufacturing process. The Company is also planning to scale-up manufacturing capacity to meet the required sample volume for the pivotal study planned for Q4 2022. Pending positive results in the pivotal study the Company will advance the product to an application for regulatory approval, starting in the EU.

XPhyto’s Rotigotine transdermal product is a single product based on Vektor’s platform technology which represents a scalable opportunity for additional TDS drug development and manufacturing programs. According to Research and Markets, the global transdermal skin patch market had a value of nearly US$6.5 billion in 2020 while Kuick Research, Pharmaceutical and Healthcare, estimate the market will reach approximately US$20 billion by 2028.

Vektor is a German narcotics manufacturer, developer, and researcher located in the district of Biberach, Baden-Württemberg, Germany. For over a decade, the company and its team have been leaders in the design, testing and manufacture of innovative, non-invasive drug delivery systems, particularly transdermal patches and sub-lingual strips for the delivery of active pharmaceutical ingredients for the treatment of pain and neurological conditions. According to Precedence Research, the global drug delivery market was valued at US$1,476 billion in 2021 and is expected to grow to US$2,047 billion by 2030.

Executive management of XPhyto’s drug formulation business is led by Prof. Dr. Beckert, managing director of Vektor Pharma TF GmbH.

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