Spain's Sanifit raises €72 million for rare disease drug trial

Sanifit has raised €72.2 million ($80.9m) in Spain’s largest private biotech fundraiser to finance phase 3 clinical development of its rare disease drug SNF472.

Based in Palma, Sanifit is developing SNF472 to treat calcific uremic arteriolopathy (CUA), a devastating rare disease that leads to the death of around 55% of patients within the first year of diagnosis.

In phase 2 studies, SNF472 met its primary and secondary goals in calciphylaxis patients and has been designated an orphan drug in Europe and the US.

Sanifit is preparing a pivotal phase 3 study testing SNF472 in CUA, which is scheduled to begin in the final quarter of this year.

The financing consists of a 55.2 million euro series D round led by Spain’s Caixa Capital Risk, in addition to selling 17 million euros of convertible bonds.

New investors Columbus Venture Partners and Alta Life Sciences chipped in, in addition to an international consortium of existing shareholders including Denmark’s Lundbeckfonden Ventures, Spain’s Ysios Capital and Health Equity, Forbion Capital Partners and Gilde Healthcare from the Netherlands, France’s Andera Partners, and several private individuals.

SNF472 is also being assessed in a phase 2b proof of concept study CaLIPSO, assessing the effect of SNF472 in reducing the progression of cardiovascular calcification (CVC) in haemodialysis patients and is expected to read out in Q4 2019.

Accelerated CVC leads to other calcification-related diseases, like peripheral arterial disease or cardiovascular disease, which the company described as “near-term” opportunities.

Sanifit described SNF472 as the hexasodium salt of myo‑inositol hexaphosphate, a calcification inhibitor with a novel mechanism of action for the treatment of haemodialysis patients with cardiovascular diseases linked to calcification.

It works by inhibiting the development and progression of ectopic calcifications by binding to the growth sites of the hydroxyapatite crystal, the main component of cardiovascular calcification deposits.

The drug has been tested in 200 patients and healthy volunteers across four clinical trials, and has been shown to be well tolerated, Sanifit said.