Sanifit agreed with the FDA on key aspects of the clinical program, including the endpoint for the pivotal Phase 3 study.
There are approximately 175,000 and 150,000 ESRD patients with PAD in the U.S. and Europe, respectively, without approved treatments
Palma, Spain and San Diego, USA, July 20, 2020 – Sanifit, a clinical-stage biopharmaceutical company developing treatments for calcification disorders, today announces that it will begin a new clinical development program to investigate the effect of SNF472 in end-stage renal disease (ESRD) patients with peripheral arterial disease (PAD), a cardiovascular disease that affects the peripheral arteries by reducing blood flow to the extremities.
PAD leads to reduced mobility, lower extremity pain, and can lead to limb ischemia and amputation. A distinguishing feature of PAD in ESRD is the profound degree of arterial calcification, with a prevalence of PAD in chronic hemodialysis patients of up to 37%.
The clinical program will consist of a cross-sectional study, planned to begin in the third quarter of 2020, in a target population of ESRD patients with PAD. Subsequently, a single pivotal Phase 3 study will be initiated in 2021.
The clinical program was recently discussed with the FDA. The agency recognized that PAD in ESRD represents an important unmet medical need and agreed with key aspects of the program, including the endpoint for the pivotal study. The Phase 3 study design and protocol will be finalized after completion of the cross-sectional study.
Results from a randomized placebo-controlled Phase 2b study (CaLIPSO) presented at the American Heart Association (AHA) in 2019 and published in the journal Circulation demonstrated that SNF472 reduces the progression of calcification in coronary arteries compared to placebo (Raggi, 2020) and, therefore, may lead to clinical benefit in cardiovascular diseases such as PAD. SNF472 has also been shown to be associated with improved wound healing and pain in a phase 2 study in patients with calciphylaxis and is currently in clinical phase 3 (CALCIPHYX study).
Joan Perelló, CEO of Sanifit, said: “We are excited to initiate this program in PAD for such a serious condition for which there are currently no treatment options. Given the prominent role of calcification in this disease, the clinical and preclinical data, we believe SNF472 has potential for clinical benefit.”
Dr. William Hiatt, Professor of Medicine (Cardiology) at the University of Colorado and CPC Clinical Research (an academic research organization affiliated with the University) commented: “PAD is a very serious condition that leads to significant complications in ESRD patients on dialysis with increased morbidity and mortality. PAD results in impaired walking ability, quality of life and ultimately increases the overall risk of amputation and death. There is currently no effective treatment for ESRD patients with PAD, and previous clinical trials have excluded these patients. Therefore, this clinical program represents a great opportunity to take advantage of promising data showing the ability of SNF472 to inhibit vascular calcification, an important driver of disease in these patients, and investigate its ability to improve function and quality of life in these patients.”
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More about Sanifit: www.sanifit.com