Pantec Biosolutions AG announced that it has achieved excellent results in a Phase I clinical trial of a FSH (follicle stimulating hormone) patch used in conjunction with the company’s novel P.L.E.A.S.E.® (Painless Laser Epidermal System) technology. Although smaller peptides and some proteins have previously been delivered transdermally, this is the first time a protein as large as 32 KDa, has been successfully delivered in this way.
The purpose of the study was to investigate the primary pharmacokinetic characteristics as well as the safety and tolerability of the newly developed FSH protein patch in healthy male volunteers. Due to its size and physicochemical properties FSH, a 32 KDa protein hormone, cannot permeate passively across intact skin. Therefore, prior to patch application, the skin was microporated using Pantec Biosolutions’ P.L.E.A.S.E.® laser device. This pre-treatment creates microchannels in the skin’s outermost layer, the stratum corneum, that facilitate FSH transport through the skin and accelerate its entry into the systemic circulation.
The serum profiles further demonstrated that the P.L.E.AS.E.® – FSH patch combination was able to achieve reproducible pharmacokinetics with negligible inter-individual variability. All of the volunteers considered the method to be convenient and easy to use, and there were no reports of any adverse events.
“This FSH patch Phase I trial represents a key milestone achieving proof-of-concept and demonstrating for the first time that P.L.E.A.S.E.® enables delivery of large proteins such as FSH efficiently in therapeutic amounts from a stable patch,” said Christof Boehler, CEO of Pantec Biosolutions. “This validation of P.L.E.A.S.E.® is an extremely important milestone that moves the company forward and significantly closer to commercialisation."
As a consequence of these excellent results, Pantec Biosolutions is now planning a future Phase II study with the new P.L.E.A.S.E.®-FSH patch.