XPhyto Therapeutics Corp. (CSE:XPHY, OTCQB:XPHYF) has reported positive results from a human cadaver skin permeation study of new drug formulations for its Rotigotine transdermal (TDS) patch for Parkinson's Disease.
The Rotigotine patch is based on the TDS platform technology developed by Xphyto’s wholly-owned German subsidiary, Vektor Pharma TF GmbH.
In a statement, Xphyto said a human cadaver skin permeation study, which compared Rotigotine absorption between two potential drug formulations and the name brand product, was recently completed at Vektor's EU GMP laboratory and manufacturing facility in Baden-Württemberg, Germany.
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.
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Xphyto said it intends to reproduce the human cadaver skin permeation study prior to finalizing the formula and manufacturing process.
It is also planning to scale-up manufacturing capacity to meet the required sample volume for the pivotal study for the Rotigotine TDS planned for Q4 2022.
Pending positive results in the pivotal study, the company said it will advance the product to an application for regulatory approval, starting in the EU.
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, Xphyto noted.
XPhyto is a bioscience accelerator focused on next-generation drug delivery, diagnostic, and new active pharmaceutical ingredient investment opportunities. It has research and development operations in North America and Europe, with an operational focus in Germany.
Contact the author at jon.hopkins@proactiveinvestors.com