Sanifit has raised a €55.2 million ($62.9 million) series D round. The financing sets Sanifit up to take its lead drug through phase 3 studies while exploring its potential in other progressive vascular calcification disorders.
Sanifit made headlines in 2015 when it raised the largest ever private round for a Spanish biotech. Equipped with €36.6 million in series C funds, Sanifit took SNF472 through a phase 2 program that linked the calcification inhibitor to improvements in wound healing and pain in calciphylaxis patients.
Now, Sanifit has set a new private Spanish biotech financing record. Caixa Capital Risc, a unit of one of Spain’s largest banks, led the series D with the support of two its compatriots, Columbus Venture Partners and Alta Life Sciences, that backed Sanifit for the first time. Two other existing Spanish investors in Sanifit, Ysios Capital and HealthEquity, also contributed to the series D.
Sanifit raised the rest of the money from an existing syndicate of international investor that includes Lundbeckfonden Ventures and Forbion Capital Partners. But the presence of five Spanish investors means local VCs played a significant role in a big financing.
"It says a lot about the Spanish life sciences environment. We have a number of VC firms specialized in healthcare in Spain," Sanifit CEO Joan Perelló said. "It's a large financing which always makes things more complicated but we're delighted having had the ability to attract additional investors.”
Sanifit also recently capitalized €17 million of convertible bonds, giving it a total of €72.2 million to take SNF472 through to the generation of phase 3 data in calciphylaxis, a disease that affects chronic kidney disease patients. Sanifit will use some of the rest of its series D haul to perform manufacturing scale-up and validation in anticipation of filing a NDA when it has the phase 3 data.
Calciphylaxis is defined by the accumulation of calcium in small blood vessels, leading to necrotic skin ulcers. Around 55% of patients die within one year of being diagnosed. Sanifit thinks SNF472 will bind to the sites of the main calcification deposits, leading to wound healing and pain data that enable it to become the first approved drug that targets the underlying cause of the disease.
In phase 2, Sanifit generated evidence to support its belief that SNF472 can support wound healing and the management of pain associated with calciphylaxis. Having spoken to regulators on both sides of the Atlantic, Sanifit is preparing to start a phase 3 trial that uses the same wound and pain endpoints.
The phase 3 will enroll up to 70 patients in the U.S. and certain European countries, including Spain and the U.K. Sanifit plans to start the phase 3 trial by the end of the year.
In parallel, the Spanish company will work to wrap up a phase 2b dose-finding trial that is assessing the effect of SNF472 on cardiovascular calcification in hemodialysis patients. Sanifit expects to have data from the 274-patient clinical trial at the end of the year. Data from the study could tee Sanifit up to target indications beyond calciphylaxis.