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Sanifit is a clinical-stage biopharmaceutical company focused on treatments for progressive vascular calcification disorders. The company is a spin-off from the University of the Balearic Islands, and has offices in Spain and the U.S. Sanifit’s lead compound, SNF472, is a novel small molecule, and a selective and potent inhibitor of hydroxyapatite (HAP) crystallization, the final common pathway that leads to vascular calcification. Its clinical development is focused on two indications in End Stage Kidney Disease (ESKD) patients; calciphylaxis and peripheral artery disease (PAD).

SNF472 is in Phase 3 clinical development for the treatment of calciphylaxis or CUA (calcific uremic arteriolopathy) in ESKD patients that will measure two alternate primary endpoints – wound healing and pain. SNF472 is orphan designated for the treatment of calciphylaxis by FDA and EMA.

The company conducted a Phase 2b trial (CaLIPSO) to assess the effect of SNF472 on slowing arterial calcification, a major risk factor for cardiovascular diseases in patients on dialysis. The trial met its primary endpoint in reducing coronary artery calcium progression in patients treated with SNF472 compared to patients receiving placebo over a 52-week period. A phase 3 trial in Peripheral Arterial Disease in ESKD will launch in 2021. PAD-ESKD is driven by progressive calcification of peripheral arteries and disease progression can lead to reduced walking ability, claudication and amputations.