7 March 2018 - - Palma, Spain and San Diego, California-based clinical-stage biopharmaceutical company Laboratoris Sanifit S.L. has completed 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, the company said.
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 US, Spain, and the UK.
Calciphylaxis, a rare condition characterised by vascular calcification and thrombosis leading to necrosis of the skin and fatty tissues, is predominantly seen in end stage renal disease 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 is an intravenous formulation with a novel mechanism of action for haemodialysis patients with cardiovascular diseases linked to calcification. It is being developed for two indications: cardiovascular disease in dialysis patients, and the treatment of calciphylaxis
SNF472 selectively blocks the pathological cardiovascular calcification progression and poses an innovative solution for these unmet medical needs. The intravenous route is promising for dialysis patients as it assures 100% compliance.
Sanifit is focused on the development of SNF472. The company was founded in 2007 as a spin-off of the University of the Balearic Islands and expanded its activities in the USA in 2016 with the incorporation of a subsidiary with offices in San Diego.