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Who we are
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).
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.
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.
A phase 3 trial in Peripheral Arterial Disease in ESKD will launch in 2021. PAD in ESKD is driven by progressive calcification of peripheral arteries and disease progression can lead to reduced walking ability, claudication and amputations.
Board of directors
Our CEO, Joan Perelló, discussed with John Simboli from the BioBoss podcast how Sanifit was unexpectedly founded, his work as an academic and the Company’s work tackling cardiovascular calcification. Listen to the full podcast: https://bit.ly/3npZ3l0
Sanifit Granted Orphan Drug Designation by the FDA for SNF472 for the Treatment of Peripheral Arterial Disease in Patients with End-stage Kidney Disease
Palma, Spain and San Diego, USA, February 10, 2021 – Sanifit, a clinical-stage biopharmaceutical company focused on developing treatments for calcification disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead compound SNF472 for the treatment of peripheral arterial disease (PAD) in patients with end-stage […]
Palma, Spain and San Diego, USA, January 7, 2021 – Sanifit, a clinical-stage biopharmaceutical company focused on developing treatments for calcification disorders, today announced its participation in the 2021 ICR Conference. Joan Perelló, Ph.D., Chief Executive Officer, will participate in a virtual fireside chat led by Christopher Raymond, Managing Director and Senior Research Analyst at […]
Palma, Spain and San Diego, USA, November 24, 2020 – Sanifit, a clinical-stage biopharmaceutical company focused on developing treatments for calcification disorders, today announced that Joan Perelló, Chief Executive Officer, and Adam Levy, Chief Financial Officer, will participate in two virtual investor conferences in December. Evercore ISI 3rd Annual HealthCONx Virtual Conference Management will participate […]
Subgroup Analyses from Sanifit’s CaLIPSO Phase 2b Clinical Study Published in Kidney International Reports
Palma, Spain and San Diego, USA, November 10, 2020 – Sanifit, a clinical-stage biopharmaceutical company focused on developing treatments for vascular calcification disorders, today announces the publication of subgroup analyses from its Phase 2b CaLIPSO clinical study in Kidney International Reports. CaLIPSO studied the effect of SNF472 over 52 weeks on vascular calcification in […]
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