Laboratoris Sanifit S.L., a clinical-stage biopharmaceutical company focused on treatments for calcification disorders, has announced the completion of its Phase II clinical trial of SNF472, its lead candidate for the treatment of the orphan disease calciphylaxis (calcific uraemic arteriolopathy, CUA), with both primary and secondary endpoints being successfully met. Full trial results will be presented at a scientific meeting in mid-2018.
The Phase II clinical trial was an open label, single arm, repeat dose study which assessed the effect of 12 weeks of treatment with SNF472 on wound healing in calciphylaxis patients receiving dialysis. The results of the study showed that both the primary endpoint, wound healing, and the secondary endpoint, reduction of pain, were successfully met. The study was conducted in the USA, Spain and the UK.
Calciphylaxis is a rare condition characterised by vascular calcification and thrombosis leading to necrosis (cellular death) of the skin and fatty tissues. The condition is predominantly seen in end stage renal disease (ESRD) patients receiving dialysis therapy.
Patients suffering from calciphylaxis experience painful skin ulcers leading to a high risk of infection and a mortality rate of 55% in the first year after diagnosis. SNF472 has been granted orphan drug designation by both the US Food & Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of calciphylaxis.
Dr Alex Gold, Chief Medical Officer of Sanifit, said: “We are very pleased with the results of the study. There is a high unmet medical need for treatment of calciphylaxis and the Phase II results demonstrate that SNF472 has considerable potential for ESRD patients suffering from calciphylaxis. This is a devastating condition with high morbidity and mortality and no approved treatment options.”
Sanifit is preparing to initiate a Phase III trial in 2018 after finalisng the ongoing dialogue on its design with the FDA and the EMA.