Pantec Biosolutions AG, a privately owned company developing innovative transdermal drug delivery products, recently announced 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 molecule as large as this protein (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 stratum corneum, facilitating FSH transport through the skin and accelerating its entry into the systemic circulation.

The serum profiles further demonstrated the P.L.E.A.S.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 commercialization."

Currently, FSH is self-administered by the patients for 10 to 12 days by daily subcutaneous or intramuscular injection stimulating follicle growth during an In Vitro Fertilisation (IVF) protocol. FSH is used in all major IVF procedures. The patch will avoid these multiple injections, improving ease of use and convenience. 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.

Pantec Biosolutions AG is a private drug delivery company specializing in using laser microporation technology to deliver large molecular weight drugs into the epidermis for local or systemic uptake. Its proprietary P.L.E.A.S.E. platform enables efficient, needle-free, and painless administration of biopharmaceutical drugs, in varying and individualized dosages, through partnered patch technology. The technology is currently in clinical trials for the delivery of IVF hormone therapy, a market with an estimated value of $1.5 to $2 billion.