Sanifit begins Phase I clinical trials to treat calciphylaxis
Sanifit Laboratories received authorization from the MHRA and the ethics committee to initiate Phase I studies in London. These tests, which began last month, evaluate in healthy volunteers and dialysis patients, the safety, pharmacokinetics and efficacy of SNF472, the experimental drug for the treatment of calciphylaxis, which has demonstrated an excellent safety-efficacy profile in different animal models.
Calciphylaxis is a rare disease with a high mortality rate (over 80 %) that affects between 1 and 4% of all dialysis patients, with an average life expectancy of 1 year from diagnosis and a huge impact on the patient’s quality of life. Calciphylaxis has its origin in the massive cardiovascular calcification of small peripheral blood vessels and there are currently no approved alternative treatments. Sanifit received orphan designation for SNF472 by the EMA and the FDA.
The company licensed its first product in 2013, based on the same scientific principles against calcification, at one of the major pharmaceutical companies, to treat dental calcification (plaque) through its use in toothpastes and mouthwashes.
Sanifit Laboratories is a Spanish biopharmaceutical company headquartered in ParcBIT, and has been involved since 2007 in the discovery and development of compounds against diseases related to calcification of tissues and organs. Since its beginnings, Sanifit has been financed by venture capital instruments of “La Caixa”, and the company has Caixa Capital BioMed and several private investors (business angels), as investors.