December 27, 2014 5:17 AM ET

Pharmaceuticals

Company Overview of Cerenis Therapeutics SA

Company Overview

Cerenis Therapeutics SA, a pharmaceutical company, engages in discovery, development, and commercialization of high-density lipoprotein (HDL) compounds for the treatment of cardiovascular and metabolic diseases. The company’s products include Cerenis HDL, PPAR delta compounds, and HDL enhancers, which reverse atherosclerotic disease by enhancing natural cardioprotective mechanism in humans. Cerenis Therapeutics SA was founded in 2005 and is based in Labege, France. The company has operations in Ann Arbor, Michigan; and Toulouse, France.

BP 87519

Rue de la Découverte

cedex

Labege,  31675

France

Founded in 2005

Phone:

33 5 62 24 97 06

Fax:

33 5 62 19 04 17

Key Executives for Cerenis Therapeutics SA

Co-Founder
Age: 55
Vice President of Finance
Senior Vice President of Clinical Development
Age: 53
Chief Medical Officer
Age: 60
Chief Medical Officer
Compensation as of Fiscal Year 2014.

Cerenis Therapeutics SA Key Developments

Cerenis Therapeutics Receives EMA Orphan Drug Designations for CER-001 for the Treatment of ApoA-I and ABCA-1 Deficiencies

Cerenis Therapeutics announced that it has received two separate Orphan Drug Designations from the European Medicines Agency (EMA) for the use of CER-001 in the treatment of patients with rare genetic defects in HDL synthesis/maturation pathways, specifically apoA-I deficiency and ABCA1 deficiency. Inherited defects in the apoA-I gene or the ABCA1 gene in both homozygous and heterozygous forms can act in a dominant manner to cause Familial Primary HypoAlphalipoproteinemia (FPHA), a rare syndrome characterised by the absence of or a severe deficiency of HDL particles in the circulation. Due to either the impaired production/maturation or the premature destruction of HDL particles, the Reverse Lipid Transport (RLT) pathway, the body's only natural mechanism for the elimination of cholesterol, is compromised. Patients experience a rapid accumulation of cholesterol, particularly in blood vessels, which often results in accelerated atherosclerosis and premature cardiovascular disease. Proof-of-mechanism data supporting the orphan designation application were obtained from the SAMBA Phase II efficacy and safety trial of CER-001 in patients with FPHA and were presented at the European Atherosclerosis Society in June 2014. The data from this trial showed that CER-001 reconstituted the RLT pathway in individuals who have defects in the natural HDL pathway and facilitated elimination of cholesterol from the body. Importantly, one month of treatment with 9 doses of CER-001, provided on top of optimized standard of care for LDL-c-lowering therapy, resulted in a statistically significant reduction in carotid artery Mean Vessel Wall Area, as measured by Magnetic Resonance Imaging (3T-MRI). CER-001 was well-tolerated.

Cerenis Therapeutics Mulls Raising Funds

Cerenis Therapeutics SA is considering selling shares in an initial public offering. Cerenis Therapeutics SA's Chief Executive Officer Jean-Louis Dasseux said that Cerenis may opt for another round of financing before it holds an initial public offering. The process for the next round of financing, whether it’s a private round or an IPO, or both, will start in October 2014.

Cerenis Therapeutics Reports 2 Positive Phase II Studies, SAMBA and MODE

Cerenis Therapeutics announced that two of its Phase II studies, SAMBA and MODE (Modifying Orphan Disease Evaluation), with CER-001, an engineered human apoA-I-containing pre-ß HDL mimetic, met their primary clinical endpoints in patients with Familial Primary Hypoalphalipoproteinemia (FPHA) and Homozygous Familial Hypercholesterolemia (HoFH), respectively. SAMBA clinical trial: Proof-of-Mechanism data will be presented at the EAS from the SAMBA Phase II efficacy and safety trial in patients with Familial Primary Hypoalphalipoproteinemia (FPHA), a rare syndrome of severe HDL deficiency caused by mutations in the genes responsible for HDL synthesis /maturation and characterized by accelerated atherosclerosis. The Netherlands, enrolled 7 FPHA patients in an open-label single-arm active-treatment study and assessed the efficacy of infused CER-001 engineered human apoA-I-containing pre-ß HDL particles in reconstituting the endogenous Reverse Lipid Transport in individuals who have defects in the natural HDL pathway and facilitate elimination of cholesterol from the body. The data from patients receiving CER-001 treatment on top of optimized standard of care LDL-c-lowering therapy showed that CER-001 performed the four steps of the Reverse Lipid Transport pathway: CER-001 increased cholesterol mobilization and esterification in the HDL fraction, and one month of treatment with 9 doses of CER-001 resulted in a statistically significant reduction in carotid artery Mean Vessel Wall Area, as measured by Magnetic Resonance Imaging (3T-MRI). CER-001 was well-tolerated. MODE clinical trial: Cerenis also reported that data from the MODE (Modifying Orphan Drug Evaluation) trial, a Phase II efficacy and safety study in patients with Homozygous Familial Hypercholesterolemia (HoFH), a rare disease of markedly elevated LDL-cholesterol (bad cholesterol) levels caused by genetic defects in the LDL-receptor pathway and characterized by premature atherosclerosis. Data will also be presented as a late-breaking clinical trial at the EAS. The open-label single-arm active-treatment study in 23 patients with homozygous FH met the prespecified primary clinical endpoint in the modified Intention to Treat population, demonstrating a statistically significant reduction in carotid artery Mean Vessel Wall Area, as measured by Magnetic Resonance Imaging (3T-MRI), after 6-months of bi-weekly CER-001 treatment on top of optimized LDL-c-lowering therapy, including apheresis. CER-001 was well-tolerated.

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