New approach to
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 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.
PROJECT SUPPORTED BY
Título: RETOS COLABORACION
Nombre del Ministerio: Ministerio de Ciencia, Innovación y Universidades
Biotech innovation in Spain: the European Investment Bank provides €20 million in financing to Sanifit to develop treatments for vascular calcification
The EU bank will support Palma-based Sanifit in its work to develop cutting-edge solutions in biomedical research. The venture debt operation is supported by the Investment Plan for Europe. Palma, Spain and San Diego, USA, 6 August 2020 – The European Investment Bank (EIB) is set to support the development of new treatments […]
Sanifit to start new clinical development program of SNF472 in End Stage Kidney Disease patients with Peripheral Artery Disease
FDA has agreed to key aspects of the clinical program, including the primary endpoint for the single pivotal phase 3 study There are approximately 175,000 and 150,000 ESKD patients with PAD in the USA and Europe respectively with no approved treatments Palma, Spain and San Diego, USA, 20 July 2020 – Sanifit, a clinical-stage biopharmaceutical […]
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 […]
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