Four oral session and ePoster presentations focus on the effect of SNF472
on vascular calcification disorders
Palma, Spain and San Diego, USA, October 22, 2020 – Sanifit, a clinical-stage biopharmaceutical company focused on developing treatments for vascular calcification disorders, today announced the presentation of new data on its lead asset SNF472 at the American Society of Nephrology (ASN) Kidney Week 2020 Annual Meeting.
SNF472 is the first-in-class inhibitor of vascular calcification currently in phase 3 clinical development. It is the only experimental drug in clinical trials that directly targets solid calcium (hydroxyapatite, PAH) deposition in the cardiovascular system, a major contributor to morbidity and mortality in patients with kidney disease. At today’s ASN Virtual
conference, Sanifit is presenting new data on SNF472 in four presentations, including an oral session and three ePoster sessions.
Today’s oral presentation by Dr. Glenn Chertow, Professor of Medicine and Chief of the Division of Nephrology at Stanford University, provides additional information from the Phase 2b CaLIPSO study (positive primary data published in Circulation in November 2019) and shows that SNF472 consistently decreased the progression of coronary artery calcification (CAC) in
key subgroups of hemodialysis patients who participated in the study. The benefit was seen in patients receiving contemporary treatment for end-stage renal disease, including phosphate binders, calcimimetics, statins and other standard therapies. An ePoster also released today highlights pharmacokinetic-pharmacodynamic and exposure-response analyses in the CaLIPSO trial. Higher SNF472 exposure and greater ex vivo inhibition of PAH crystallization (pharmacodynamic activity) correlated with reduced progression of coronary calcification in patients and no drug accumulation.
Sanifit is also presenting in an ePoster the design of its randomized, double-blind, placebo-controlled Phase 3 study called CALCIPHYX. The study, currently ongoing, evaluates the efficacy and safety of SNF472 for the treatment of patients with calciphylaxis (calcifying uremic arteriolopathy or CUA), a disease with high morbidity and mortalitya of vascular calcification and skin necrosis.
Additional data presented today also demonstrate that SNF472 strongly inhibits valvular calcification in an in vitro porcine aortic valve model.
“This is a robust data set and we are pleased to present it at this year’s ASN Virtual Congress. In particular, we are delighted to share details of the innovative design of our Phase 3 CALCIPHYX trial, which includes two alternative primary endpoints and is actively recruiting according to our plan,” said Joan Perelló, Ph.D., CEO of Sanifit. “These data demonstrate the potential of SNF472 to help patients around the world suffering from the consequences of vascular calcification. There are currently no approved treatments for calciphylaxis and we expect SNF472 to provide benefits to these patients.”
The congress runs from October 22-25 and is completely virtual, with more information available on the ASN website. Links to abstracts and details of the schedule of presentations are as follows:
Title: SNF472 Consistently Slows Progression of Coronary Artery Calcification Across Subgroups of Patients on Hemodialysis
Date and time: Thursday, October 22, from 5:00 p.m. to 7:00 pm. EDT
Presentation code: OR0401 (oral presentation)
Link to summary.
Title: Design of the CALCIPHYX Study, a Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of SNF472 for Treating Calciphylaxis
Date and time: Thursday, October 22, from 10:00 a.m. to 12:00 p.m. EDT
ePoster Code: INFO07
Link to summary.
Title: PK-PD and exposure-efficacy evaluation from CaLIPSO, a phase 2B study to assess the effect of SNF472 on progression of cardiovascular calcification in patients on hemodialysis.
Date and time: Thursday, October 22, from 10:00 a.m. to 12:00 p.m. EDT
ePoster Code: PO1142
Link to summary.
Title: SNF472 inhibits heart valve calcification in a novel in vitro method using porcine whole leaflets.
Date and time: Thursday, October 22, from 10:00 a.m. to 12:00 p.m. EDT
ePoster Code: PO0320
Link to summary.
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More about Sanifit: www.sanifit.com