GlycoOptimized Follicle-Stimulating Hormone FSH-GEX (GT-GP 2.4-GEX)

The follicle-stimulating hormone (FSH) is responsible for follicle maturation. Its main clinical use is administration during the onset of in vitro fertilization procedures to induce maturation of multiple oocytes for retrieval.

Currently, approved preparations of FSH originate from either human urine or recombinant sources from non-human cells. While urinary versions of FSH carry a heterogeneous but human glycosylation, the generally better biological safety of recombinant products makes them the product of choice for most patients, despite a non-human glycosylation profile and higher product costs associated with the treatment.

Glycotope’s glycooptimized and fully human version of FSH, FSH-GEX™, combines the advantages of both product types into one single product and adds efficacy advantages. The aim of the program was to generate a BioSuperior molecule mimicking the FSH of a healthy woman. Using GlycoExpress™, which allows for fully human glycosylation and optimization of this process, FSH-GEX™ showed an improved activity in human in vitro assays as well as in the first trials and superior production yields and reproducibility of quality by production in GlycoExpress™. It thereby provides the safety advantages of a recombinant protein with the advantages of a fully human glycosylation and an optimized glycosylation.

Phase III is scheduled to start in Q3 / 2014.