Sanifit Utilizes Calcium Phosphate Chemistry To Treat Rare Renal Disease

Sanifit Laboratories, a small biotech with offices in Palma and San Diego, wants to apply 1960s calcification chemistry to heart disease conditions in renal failure patients.

To date, Sanifit has raised over €40m equity to progress development of its lead product, SNF472, in cardiovascular disease in end-stage renal failure patients and in the rare disease calciphylaxis. The company is backed by several international investors including Caixa Capital Risc, MGA Business Consulting, Health Equity, YSIOS Capital, Forbion Capital Partners, Gilde Healthcare and Edmond de Rothschild; as well as two pharma venture groups, Baxter Ventures and Lundbeck Fund.

Sanifit's Pipeline

SNF472 is an experimental drug for the treatment of cardiovascular diseases linked to calcification in the end-stage renal disease population undergoing haemodialysis. The drug, which contains hexasodium phytate, works by stopping the progression of, and reducing, calcification in patients to reduce the risk of cardiovascular events.

Sanifit is targeting two indications for SNF472 within the renal failure setting: cardiovascular diseases linked to calcification and calciphylaxis, or calcific uremic arteriolopathy, which is a syndrome of vascular calcification, thrombosis and skin necrosis. There are currently no approved pharmaceuticals for either of these indications.

Calciphylaxis, an orphan disease, is seen mostly in patients with stage 5 chronic kidney disease but can occur in the absence of renal failure. The current standard of care includes both medical and surgical interventions. However, intravenous sodium thiosulfate, an antioxidant which works in a similar way to Sanifit's drug by increasing the solubility of calcium deposits, has been used off-label to treat calciphylaxis.

According to Informa Pharma Intelligence's BioMedTracker database, there are no other trials ongoing specifically targeting calciphylaxis. However, clinicaltrials.gov does list a handful of studies for products treating some symptoms of calciphylaxis.

Sanifit's CEO and co-founder, Dr. Joan Perello, told Scrip that other drug developers active in this area are targeting the classical risk factors related to cardiovascular disease, such as hypertension, but Sanifit is targeting the calcium phosphate build-up in arteries. "There are some products to control calcium in the blood and others to control phosphate but no one else is targeting the crystals that develop in the arteries," Perello said. "Our target is an organic solid stone. The chemistry around our product was developed in the '60s but it has not yet been successfully applied to medicine."

From 2009 to 2013 Perello pioneered the international development of Sanifit’s lead candidate from academia to its clinical evaluation and SNF472 entered Phase II for calciphylaxis in Oct. this year. This trial marks the first clinical investigation of the drug in patients with newly diagnosed calciphylaxis. Sanifit expects top-line data from this study in the second half of 2017.

Meanwhile, for the larger of the two indications Sanifit is targeting with SNF472, cardiovascular calcification related to end-stage renal disease, a Phase IIb program has been approved by regulators and is due to start enrolling patients soon. Sanifit expects to enroll around 400 patients in this Phase IIb study, which will have clinical sites in four European countries and the US. Sanifit estimates that there are approximately 2.5 million dialysis patients worldwide with no effective treatment for this medical condition. To date SNF472 has completed more than 20 preclinical studies and was safe and tolerable in a Phase I clinical trial in healthy volunteers and hemodialysis patients after one month of exposure.

What’s Next?

Perello told Scrip that the company had been able to attract the attention of numerous investors because it has a novel target and a "totally new approach" to heart disease in dialysis patients. "We are also building a clinical strategy that will allow us to meet our objectives within a reasonable timeframe," Perello said.

He added that there was great market potential for a successful product targeting calcium phosphate build-up in renal failure patients.

Sanifit has the funds and management team to progress its rare disease program for SNF472 into Phase III, Perello said – a stage he hopes to reach by 2019. But the company is evaluating partnership options, particularly involving pharmaceutical companies with nephrology expertise, pipeline products in development for indications in this field or a sales force able to take on a product like SNF472.

Perello anticipates the company might get more interest for its rare disease indication from partners, but a deal for Sanifit would have to include a commitment to continue development of its lead drug in the wider end-stage renal failure patient population.

Aside from SNF472, Sanifit also has a pipeline of over the counter products. These include ASB-01 for dental health and SNF671 and Phytech for bone health. The company's management team includes: chief scientific officer, Dr. Carolina Salcedo; chief medical officer, Dr. Preston Klassen; and finance director, Richard Peach.

Brought to you from the editors of Start Up.