XPhyto Therapeutics Corp (CSE:XPHY) (OTCMKTS:XPHYF) (FRA:4XT) offered investors an update on its transdermal delivery system for the neurologic drug Rotigotine, saying that based on “encouraging study results”, the Rotigotine development program will be advanced to a pivotal human trial.
Vancouver-based XPhyto Therapeutics first revealed in January that its German subsidiary Vektor Pharma TF GmbH focused on a human bioavailability pilot study of its Rotigotine transdermal patch for Parkinson's disease sufferers during the first quarter, ahead of human pilot studies.
“The company is pleased to announce the Rotigotine study was completed successfully in March 2021,” said XPhyto. It added that based on “the encouraging study results” the Rotigotine development program will be advanced to a pivotal human trial.
READ: XPhyto Therapeutics rapidly advances its drug delivery system for Parkinson's skin patches
The company’s goal is the commercialization of a low-cost Rotigotine patch with superior bioavailability and adhesion properties.
Rotigotine is approved for the treatment of Parkinson's disease and restless legs syndrome in Europe and the US. 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 earlier noted.
Meanwhile, in anticipation of Vektor's rapid drug product commercialization schedule, XPhyto told its shareholders that it has signed a purchase and sale agreement for a property in Biberach, Germany to build a new drug manufacturing facility. “The estimated maximum capacity of the lab and manufacturing space permitted on the property is 32,000 square foot,” said the firm.
XPhyto added that it is “reviewing scalable construction options to synchronize its manufacturing capacity with demand from in-house and contract manufacturing opportunities.”
"Vektor continues to build shareholder value by advancing its product development pipeline. Its lead program is now progressing to a pivotal human study in Europe, which is the final major milestone on the path to commercial regulatory approval," XPhyto Therapeutics CEO Hugh Rogers said in a statement.
"The addition of in-house, scalable commercial drug manufacturing capability is expected to add further value and optionality to XPhyto's drug formulation and manufacturing businesses," he added.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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