Vyteris, Inc. and Ferring Pharmaceuticals have announced results from a completed Phase 1 clinical trial demonstrating that Vyteris’ patented Smart Patch transdermal technology successfully delivered a peptide molecule in humans (multiple pulse) without the use of needles (non invasively) in therapeutic levels aimed at the treatment of female infertility.
“These trial results represent a significant accomplishment for Vyteris in demonstrating that our delivery system are capable of achieving therapeutic levels of a peptide without using any needles,” said Timothy J. McIntyre, chief executive officer of Vyteris.
“This is the initial step in potentially clearing the pathway to pursue eventual commercialization of this technology and its broader applications to other peptides, which as a class of biotechnology drugs, are severely limited to delivery by subcutaneous (subQ) / intramuscular (IM) injections or intravenous (IV) infusions,” McIntyre continued.
As part of the trial agreement between Vyteris and Ferring Pharmaceuticals, the study results showed that therapeutic levels of the peptide in humans are achievable without the use of injections or infusion pumps. The clinical trial was conducted in the U.S. with 30 healthy volunteers under an investigational new drug application (IND). Specific technical data will undergo peer review for future disclosure.
Kenneth Kashkin, Chief Medical Officer and Senior Vice President Global Clinical Research and Development of Ferring Pharmaceuticals, provided an assessment on the importance of this clinical advance: “Significant technological advances, not previously achieved in peptide delivery, have been accomplished by the Ferring/Vyteris team, and we look forward to successfully completing Phase I.”
In the Phase I clinical trial, a pulse profile controlled the transdermal delivery of the peptide from patches loaded with different concentrations of the peptide. The amounts of peptide delivered using the patch were comparable or higher than with subcutaneous (subQ) injection.
The study used different formulations within the Vyteris patch that were compared with subQ delivery of the peptide. No unexpected adverse side effects were observed in any of the trial participants.
“We will continue our development efforts with the current peptide in our partnership effort with Ferring ,” McIntyre added.
“On a broader commercial front, we believe this can have a tremendous impact on the lives of patients who are currently limited to less convenient and more costly subcutaneous (subQ) / intramuscular (IM) injections or intravenous (IV) infusions. Further, this represents a significant opportunity for Vyteris to provide innovative solutions to the biotechnology industry in utilizing a brand new delivery channel for peptides previously limited to injection methods.”
The product under development by Vyteris and Ferring would employ Vyteris’ patented Smart Patch drug delivery technology, which is positioned to provide a safe and effective method of delivering drugs via a pre-programmed regulating system, a characteristic important in the delivery of therapeutics for the treatment of female infertility while offering the possibility of administering the peptide without needles and is being designed to deliver multiple transdermal pulses automatically.