July 26, 2017 8:36 AM ET

Pharmaceuticals

Company Overview of Laboratoris Sanifit S.L.

Company Overview

Laboratoris Sanifit S.L., a biopharmaceutical company, develops drugs for the treatment of calcification disorders. Its therapeutic pipeline includes SNF472, an experimental drug for the treatment of cardiovascular diseases linked to calcification in the end stage renal disease population undergoing hemodialysis. The company’s OTC pipeline comprises Lit-Control, a medical device that helps to improve the quality of life of patients suffering from renal lithiasis, allowing self-monitoring of the disease by means of urinary pH control; ASB-01, an oral and dental health solution; SNF671, a food supplement for bone health; and Phytech, an implant surface treatment with bioactive molecules. Labor...

ParcBIT – Ctra Valldemossa km7.4

Building Europa

2nd floor

Palma de Mallorca,  07121

Spain

Founded in 2004

Phone:

34 971 43 99 25

Fax:

34 971 43 99 25

Key Executives for Laboratoris Sanifit S.L.

Co-Founder, Chief Executive Officer, Managing Director and Director
Finance Director
Chief Scientific Officer
Compensation as of Fiscal Year 2017.

Laboratoris Sanifit S.L. Key Developments

Sanifit Announces Enrollment of First Patient in Calipso - A Phase IIb Study for the Treatment of Cardiovascular Calcification in End-Stage-Renal-Disease Patients on Haemodialsis

Laboratoris Sanifit S.L. announced that the first patient has been enrolled in the Phase IIb "CaLIPSO Study" clinical trial of lead candidate, SNF472, for the treatment of cardiovascular calcification (CVC) in end-stage-renal-disease (ESRD) patients on haemodialysis (HD). Most ESRD patients, in the last stage of chronic kidney disease, suffer from accelerated cardiovascular calcification, which correlates with higher cardiovascular risk. Cardiovascular disease is the most common cause of death in patients with ESRD and there are currently no approved therapies for the treatment of CVC. SNF472 is being developed to address this significant medical challenge. The CaLIPSO Study is a 52-week, double-blind, randomized, placebo-controlled trial which will evaluate the effects of 300 and 600mg of SNF472 on the progression of cardiovascular calcification (CVC). The study will be conducted at approximately 75 investigation sites across the US, Spain, Italy and the UK. It is the large trial ever in the field of cardiovascular calcification with plans to enroll 400 patients and results expected in 2019.

Laboratoris Sanifit S.L Announces Initiation of First Clinical Trial of SNF472 in Patients with Calciphylaxis

Laboratoris Sanifit S.L. announced successful initiation of the first clinical trial of its lead candidate, SNF472, for the treatment of the orphan disease calciphylaxis (calcific uraemic arteriolopathy, CUA). The recently initiated Phase II study is the first clinical investigation of SNF472 in patients with newly diagnosed calciphylaxis. Designed as an open-label investigation, eligible patients will be treated over three months to assess the effect of SNF472 on wound healing and pain. The trial is led by Prof Vincent Brandenburg, University Hospital RWTH Aachen, Germany, along with a team of internationally recognized calciphylaxis experts in the US, Spain and the UK. This multi-centre study plans to enroll a total of 15 adult patients with first data expected in second quarter 2017. Calciphylaxis is a serious and rare condition characterized by vascular calcification and thrombosis leading to necrosis (cellular death) of the skin and fatty tissue. Patients with calciphylaxis experience painful skin ulcers with a high risk of severe infection and a 50% rate of death within the first year after diagnosis. The condition is seen predominantly in patients receiving dialysis therapy due to end stage renal disease (ESRD) and is related to the abnormal deposition of calcium in small blood vessels and other tissues, a process known as ectopic calcification. Approximately 1-4% of patients with ESRD experience calciphylaxis and there is currently no US Food & Drug Administration (FDA) or European Medicines Agency (EMA) approved therapy to treat this disorder. SNF472 is administered during hemodialysis in patients with ESRD. It selectively binds to hydroxyapatite and directly inhibits the initiation and progression of ectopic calcification. Preclinical models demonstrate that SNF472 reduces the progression of calcium deposition in blood vessels and cardiac tissue. SNF472 has received orphan drug designation for the treatment of calciphylaxis from both the EMA and FDA. Sanifit is also collaborating on this trial with Frenova Renal Research, a Fresenius Medical Care North America company. SNF472 is an intravenous formulation with a novel mechanism of action for haemodialysis patients with cardiovascular diseases linked to calcification. SNF472 is being developed for two indications: reduction of cardiovascular events in dialysis patients and for the treatment of calciphylaxis. SNF472 has orphan drug status for the treatment of calciphylaxis from both the EMA and FDA. SNF472 selectively blocks the pathological cardiovascular calcification progression and poses an innovative solution for these unmet medical needs.

Laboratoris Sanifit S.L. Appoints Preston S. Klassen as Chief Medical Officer; Announces Launch of Subsidiary, Sanifit Inc

Laboratoris Sanifit S.L. announced the appointment of Dr. Preston S. Klassen, MD, MHS as its Chief Medical Officer. Dr. Klassen brings nearly 14 years of industry experience to Sanifit. In addition to his CMO role within the company, Dr. Klassen will serve as President of the US subsidiary and his primary responsibilities will include leading the clinical development of SNF472 and enhancing the company's growing presence in the US. Dr. Klassen was most recently Executive Vice President, Head of Global Development at Orexigen Therapeutics. Previously, Dr. Klassen held several positions of increasing responsibility at Amgen Inc., including Therapeutic Area Head for Nephrology. The company announced launch of its US Subsidiary Sanifit Inc., based in San Diego, USA.

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