Infertility patches

Clinical proof of concept for infertility peptide and protein hormones

At present, women undergoing infertility treatment endure upwards of 40 subcutaneous or intramuscular injections of fertility hormones, as the molecules are too large for conventional transdermal delivery using a patch. These repeated injections are painful and stressful, delivering the hormones in peaks and troughs rather than more gradually as they would naturally. However, microporation of the skin using P.L.E.A.S.E.® makes it possible to deliver large molecules such as those used in IVF.

In combination with P.L.E.A.S.E.® microporation, Pantec Biosolutions’ first hormone patch IVF001 (triptorelin, a GnRH agonist) and second hormone patch IVF002 (follicle stimulating hormone, FSH) have both demonstrated excellent bioavailability, safety and tolerability in phase I clinical development.

The two patch candidates for infertility treatment, triptorelin and FSH are available for licensing based on positive human proof-of-concept.

IVF001 (Triptorelin)

Triptorelin (GnRH agonist; decapeptide with MW 1.3 kDa) is a protein that mediates the down-regulation of the pituitary gland prior to follicle stimulation with FSH. Currently women receiving infertility treatment must undergo a daily subcutaneous injection of 0.1 mg/day. Pantec Biosolutions is developing IVF001 as a patch alternative in combination with P.L.E.A.S.E.® mediated microporation.

IVF002 (FSH, Follicle stimulating Hormone)

Follicle-stimulating hormone (FSH, 30 kDa) is a hormone synthesized and secreted by gonadotropes in the anterior pituitary gland. FSH regulates the development, growth, pubertal maturation, and reproductive processes of the human body. The most commonly used FSH infertility treatment is a daily subcutaneous injection of 150 to 300 I.U. of the protein hormone over 10-12 days with the goal to stimulate egg cell (oocyte) maturisation in down-regulated women. Pantec Biosolutions is developing IVF002 as a patch alternative in combination with P.L.E.A.S.E.® mediated microporation.