Swiss biopharmaceutical company Ferring Pharmaceuticals has reported a positive outcome from the Phase III ESTHER-1 and ESTHER-2 clinical trials of its fertility drug, Rekovelle.
Rekovelle is a recombinant follicle-stimulating hormone (rFSH) extracted from a human cell line and is currently being developed to deliver individualised doses based on the body weight and serum AMH level of a patient.
The results indicated cumulative live birth rates similar to standard follitropin alfa treatment and a favourable safety profile in women with high levels of anti-Müllerian hormone (AMH).
The randomised, assessor-blind, controlled ESTHER-1 trial evaluated a fixed daily dose of Rekovelle in 1,326 patients across 11 countries, while the assessor-blind, controlled ESTHER-2 trial assessed the drug candidate’s immunogenicity in a subset of ESTHER-1 patients who were undergoing repeated cycles of controlled ovarian stimulation for ART.
Ferring Pharmaceuticals executive vice-president and chief scientific officer Per Falk said: “Rekovelle’s individualised dosing regimen, based on a patient’s AMH level and body weight, provides clinicians with a consistent, evidence-based approach to personalising treatment for their patients.
“These new Rekovelle analyses add further evidence for a personalised approach to fertility treatment for patients.”
The data from both trials demonstrated a cumulative live birth rate of 43.9% with Rekovelle for fresh embryo transfers following three treatment cycles in subjects undergoing in-vitro fertilisation (IVF), while the rate with follitropin alfa was found to be 44.5%.
Additional analysis indicated a 45.1% ongoing pregnancy rate with Rekovelle and a rate of 45.7% with follitropin alfa.
Image: Ferring Pharmaceuticals headquarters in Switzerland. Photo: courtesy of Ferring International Center.