XPhyto Therapeutics Corp (CSE:XPHY) (OTCPINK:XPHYF) offered investors an update on its transdermal delivery system for the neurologic drug Rotigotine saying the “formula was locked” and the company is looking forward to clinical studies in the third quarter of 2020.
Vancouver-based XPhyto Therapeutics first revealed in June that its German subsidiary Vektor Pharma TF GmbH had finalized the formula for its skin patch to help Parkinson's disease sufferers ahead of human pilot studies.
According to the company, Vektor Pharma has now completed process implementation for the manufacture of its Rotigotine patches. “With process implementation complete, clinical sample manufacturing and analytical work will commence in Vektor’s EU GMP laboratory and manufacturing facility based in Baden-Württemberg, Germany,” it said.
XPhyto said human bioavailability studies will take place in Europe during the third quarter, with a data read-out expected by the fourth quarter of this year.
“Our goal is the commercialization of a low-cost Rotigotine patch with superior bioavailability and adhesion properties,” XPhyto Therapeutics CEO Hugh Rogers said in a statement.
“Incorporating Rotigotine into Vektor’s novel transdermal drug delivery system platform is a major accomplishment. With the formula locked and manufacturing soon to commence, we look forward to the upcoming clinical studies,” he added.
Rotigotine is approved for the treatment of Parkinson's disease and restless legs syndrome in Europe and the United States. The active pharmaceutical ingredient is a generic off-patent drug that is typically formulated as a once-daily skin patch which provides a slow and constant supply of the drug over the course of 24 hours.
Global and European sales of Rotigotine patches last year came in at around $500 million, XPhyto noted.
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