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 patients receiving hemodialysis and showed significant reductions in progression of coronary artery calcification and aortic valve calcification in this patient population.
The newly published data show that treatment with SNF472 consistently reduced the progression of coronary artery calcium (CAC) compared with placebo in a broad range of patients receiving maintenance hemodialysis. CAC is highly prevalent and is linked with poor outcomes in patients receiving hemodialysis, and many experts believe that its reduction may improve cardiovascular function in these patients.
“We are pleased to see these data published in Kidney International Reports,” said Alex Gold, M.D., Chief Medical Officer of Sanifit. “These results show the effect of SNF472 was consistent in patients across all subgroups including those receiving standard of care therapies. These data further support the potential of this investigational agent as a treatment option for patients suffering from the effects of vascular calcification.”
The publication of these data follows an oral presentation by Dr. Glenn Chertow, Professor of Medicine and Chief of the Division of Nephrology at Stanford University, at the American Society of Nephrology last month. The presentation provided additional insight from the Phase 2b CaLIPSO study (positive primary data published in Circulation in November 2019). The results in attenuating progression of coronary artery calcium were consistent across all pre-specified patient subgroups and independent of age, sex, time on dialysis, key co-morbidities and key concomitant medicines at baseline.
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) in the cardiovascular system.
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 SNF472. For more information, please visit www.sanifit.com.
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