Sanifit Presents New Data for SNF472 in Treatment of Vascular Calcification at ASN Kidney Week 2020

Sanifit Presents New Data for SNF472 in Treatment of Vascular Calcification at ASN Kidney Week 2020

Four presentations at oral and ePoster sessions focus on the effect of SNF472 in 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 lead candidate SNF472 today at the American Society of Nephrology (ASN) Kidney Week 2020 Annual Meeting.

SNF472 is a first-in-class inhibitor of vascular calcification currently in Phase 3 clinical development. It is the only drug candidate in clinical trials which directly targets the deposition of solid calcium (hydroxyapatite, HAP) in the cardiovascular system, a major driver of morbidity and mortality in renal disease patients. At today’s virtual ASN conference Sanifit is showcasing new data on SNF472 in four presentations including one 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 insight from the Phase 2b CaLIPSO study (positive primary data published in Circulation in November 2019), and shows that SNF472 consistently slowed progression of coronary artery calcium (CAC) across key subgroups of patients on hemodialysis participating in the study. The benefit was observed in patients receiving contemporary treatment of end-stage kidney disease, including phosphate binders, calcimimetics, statins and other standard of care therapies. An ePoster also published today spotlights the pharmacokinetic-pharmacodynamic and exposure-response analyses from the CaLIPSO trial. Higher SNF472 exposure and ex-vivo inhibition of HAP crystallization (pharmacodynamic activity) correlated with a reduction in progression of coronary calcification in patients, and there was no drug accumulation.

Sanifit is also presenting the design of its ongoing Phase 3 randomized, double-blind, placebo-controlled study called CALCIPHYX in an ePoster. The study is evaluating efficacy and safety of SNF472 for the treatment of patients with calciphylaxis (calcific uremic arteriolopathy, or CUA), a highly morbid disease of vascular calcification and skin necrosis.

Additional data being presented today also demonstrates that SNF472 strongly inhibits valvular calcification in an in vitro model of porcine aortic valve.

“This is a robust set of data and we are pleased to be presenting at the ASN virtual meeting this year. In particular, we are delighted to share details of the innovative design of our Phase 3 CALCIPHYX trial, which includes alternate primary endpoints and is currently actively recruiting according to our plan,” said Joan Perelló, Ph.D., Chief Executive Officer of Sanifit. “These data demonstrate SNF472’s potential to help patients around the world suffering from consequences of vascular calcification. There are no currently approved treatments for calciphylaxis and we hope that SNF472 will provide benefit for these patients.”

The ASN conference is being held from 22-25 October and is fully virtual, with further information available on the ASN website. Links to abstracts and schedule details for presentations are below:

Title: SNF472 Consistently Slows Progression of Coronary Artery Calcification Across Subgroups of Patients on Hemodialysis

Date & Time: Thursday, October 22, from 5:00 p.m. - 7:00 p.m. EDT

Presentation Code: OR0401 (oral presentation)

Link to Abstract.

Title: Design of the CALCIPHYX Study, a Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of SNF472 for Treating Calciphylaxis

Date & Time: Thursday, October 22, from 10:00 a.m. - 12.00 p.m. EDT

ePoster Code: INFO07

Link to Abstract.

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 & Time: Thursday, October 22, from 10:00 a.m. - 12.00 p.m. EDT

ePoster Code: PO1142

Link to Abstract.

Title: SNF472 inhibits heart valve calcification in a novel in vitro method using porcine whole leaflets

Date & Time: Thursday, October 22, from 10:00 a.m. - 12.00 p.m. EDT

ePoster Code: PO0320

Link to Abstract.

About Sanifit

Sanifit is a clinical-stage biopharmaceutical company focused on treatments for 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 asset, SNF472, has successfully completed a Phase 2 proof of concept study in calciphylaxis, and showed a significant reduction in progression of coronary calcification in a Phase 2b study among hemodialysis patients. A Phase 3 pivotal study in calciphylaxis is currently underway and the Company is also pursuing peripheral arterial disease in end-stage kidney disease patients as a second indication for SNF 472. For more information, please visit www.sanifit.com.

For further enquiries:

Sanifit
Joan Perelló, CEO
Adam Levy, CFO

Investor.Relations@sanifit.com