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A new approach to
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 dialysis 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 patients undergoing dialysis 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 end stage kidney disease patients on dialysis (PAD-ESKD) will launch in the first half of 2021. PAD-ESKD is driven by progressive calcification of peripheral arteries and disease progression can lead to reduced walking ability, claudication and amputations.
PROJECT SUPPORTED BY
Título: RETOS COLABORACION
Nombre del Ministerio: Ministerio de Ciencia, Innovación y Universidades
SNF472 selectively inhibits pathological calcification by binding to hydroxyapatite crystals Palma, Spain and San Diego, USA, 25 June 2020 – Sanifit, a clinical-stage biopharmaceutical company focused on developing treatments for calcification disorders, today announced that data examining the mechanism of action of SNF472, Sanifit’s lead compound in development, has been published in the British Journal […]
Newly appointed VP of Business Development and SVP of Clinical Development each bring to Sanifit over 20 years of industry experience Palma, Spain and San Diego, USA, 01 June 2020 – Sanifit, a clinical-stage biopharmaceutical company focused on developing treatments for calcification disorders, is delighted to announce two new appointments to its Executive leadership team, […]
First patient dosed in phase 3 trial of SNF472 for the treatment of calcific uremic arteriolopathy (CUA) or calciphylaxis Palma, Spain and San Diego, USA, 13 February 2020 – Sanifit, a clinical-stage biopharmaceutical company focused on developing treatments for calcification disorders, today announced that the first patient has successfully been dosed in its pivotal […]
SNF472 significantly reduced progression of cardiovascular calcification in patients with end stage kidney disease (ESKD) receiving hemodialysis SNF472 treated patients had coronary artery calcium (CAC) volume score progression of 11% from baseline versus 20% in patients receiving placebo (P=0.016) SNF472 was well tolerated Results are remarkable as they have been achieved in patients who […]
Sanifit announces that the Phase 2b CaLIPSO trial of SNF472 met its primary endpoint in slowing the progression of cardiovascular calcification in patients on hemodialysis
Top line data to be presented at 2019 Scientific Sessions of American Heart Association Webcast to be held on Monday 18 November at 11.00 ET Palma, Spain and San Diego, USA, 30 October 2019 – Sanifit, a clinical-stage biopharmaceutical company focused on treatments for progressive vascular calcification disorders, today announced that the international Phase 2b […]
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