Sanifit completes Phase I clinical trials in healthy volunteers with SNF472
Sanifit received authorization from the MHRA and the ethics committee to initiate a Phase I study in London. These tests evaluated in healthy volunteers the safety, pharmacokinetics and efficacy of SNF472, the experimental drug for the treatment of vascular calcification and calciphylaxis, which has demonstrated an excellent safety-efficacy profile in different animal models.
A double-blind, randomized, single ascending dose study was performed in twenty healthy male volunteers. Single ascending doses of SNF472 were administered by a 4-hour infusion in a leap-frog design. Apart from standard safety parameters and pharmacokinetics, a biomarker of calcification was used to assess pharmacodynamics.
The good safety profile, together with the excellent PK-PD profile of SNF472, which were found in this study, supports the continuation of the development program. The next step will be starting clinical studies in haemodialysis patients.