A phase 2b trial of Sanifit’s SNF472 in hemodialysis patients has hit its primary endpoint, teeing the Spanish biotech up to take the calcification inhibitor forward.
Sanifit, a 2019 Fierce 15 winner, is currently gearing up to run a phase 3 trial of SNF472 in calciphylaxis, a disease characterized by the accumulation of calcium in small blood vessels that most commonly occurs in end-stage renal disease (ESRD) patients. ESRD patients on hemodialysis are prone to major, fast-progressing vascular calcification associated with cardiovascular mortality.
The latest clinical assessment of SNF472 enrolled 274 ESRD patients and randomized them to take the calcification inhibitor or placebo for 52 weeks. By the end of the study, Sanifit had linked use of its drug to reduced coronary artery calcium volume compared to placebo, resulting in the trial hitting its primary goal.
That finding appears to validate Sanifit’s belief that SNF472 can help ESRD patients by binding to the growth sites of crystals that make up the problematic calcium deposits. However, Sanifit is yet to share any numbers or information beyond the primary endpoint success, leaving scope for safety or efficacy details to undermine its case for SNF472 when it shares detailed data next month.
The presentation of the phase 2b data will provide the most comprehensive look at the effects of the drug to date. Sanifit previously shared data from a 14-subject clinical trial that assessed the effect of SNF472 on wound healing and pain. Those endpoints reflect the potential for calciphylaxis to cause necrotic skin ulcers.
At the time of its €55.2 million ($61.4 million) series D round in June, Sanifit planned to run a phase 3 trial using the same wound healing and pain endpoints as the 14-patient study. The phase 2b results suggest Sanifit may also be able to make the case for SNF472 by focusing on coronary artery calcium volume and potentially cardiovascular outcomes.
That thinking has informed Sanifit’s belief that SNF472 may have a future in indications including peripheral artery disease and cardiovascular disease, conditions that affect significant numbers of ESRD patients.