Positive Safety and Tolerability Profile of CER-001 Presented at the European Society of Cardiology (ESC) Congress 2016

Professor Alberto Corsini, Department of Pharmacology and Biomolecular Sciences, University of Milan, Italy, presented CER-001 data at ESC

Regulatory News:

Cerenis Therapeutics (Paris:CEREN) (FR0012616852 – CEREN), every international biopharmaceutical company dedicated to the discovery and development of innovative HDL therapies (“abundance cholesterol”) for treating cardiovascular and metabolic diseases, today announces the gift of a poster on the categorical tolerability and safety findings of its drug candidate CER-001, at the bring to pass of the European Society of Cardiology congress, which will be held from the 24th to 31st August 2016 in Rome.

The unequivocal safety and tolerability profile of CER-001 observed in the clinical hardship program to date supports its continued disentanglement as both a short- (post-ACS people) and a long-term treatment (HDL-defective patients).

Clinical trials in patients by familial hypercholesterolaemia or hypoalphalipoproteinaemia have shown that CER-001 reduces carotid wall density and enhances cholesterol excretion, thus reducing atherosclerotic burden1. Furthermore, encouraging potency results have also been reported by CER-001 in patients with violent coronary syndrome (ACS)2.

This bill reports the clinical tolerability and close custody findings seen with CER-001 thwart the clinical development programme, to begin, and determines whether any specific method of treating-related adverse events (AEs) emerge for example clinical experience with the product grows.

The results of the Phase I placebo-controlled study, that involved 32 subjects, showed CER-001, athwart a wide dose range of 0.25 to 45 mg/kg, to get a tolerability profile similar to that of placebo. Moreover, this study showed that CER-001 significantly mobilises cholesterol in the HDL bit without causing significant elevation of liver enzymes, calm at the higher doses. Additionally, none adverse effects of CER-001 steady ECGs were observed and no antibodies to ApoA-I, the ingenuous protein in HDL contained in the CER-001 mingled, were detected following single dose management.

Pooling safety and tolerability data from 530 patients involved in the completed Phase II studies that evaluated multiple doses of CER-001 transversely the range 3–12 mg/kg found a safety profile that is to be compared with placebo. No unusual or concerning AEs have been reported to time and after six administrations, one either week, in post-ACS patients, in ~ degree antibodies against ApoA-I were detected at 6 months. CER-001 is not associated through any adverse impact on hepatic safety as no clinically relevant differences in elevations of liver enzyme levels between CER-001 and placebo have been observed.

Professor Alberto Corsini of the Department of Pharmacology and Biomolecular Sciences, University of Milan, commented, “While the evaluation of competency data is important, the collection and simple entertainment of safety data on CER-001 that is gathered during the Phase I and II clinical disentanglement programme is of critical importance in the more distant development of this candidate drug. Following multiple doses athwart a 6-month period, CER-001 appears to accept a clinical safety profile similar to that of placebo and the solicitant drug was not associated with at all hepatic safety concerns. These reassuring safety results support the continued clinical unravelling of CER-001 for both brief- and long-term treatment.”

The detailed poster, presented by Dr Nicola Ferri to the ESC congress forward 30 August 2016, is available in successi~ the website of Cerenis in the tab “Our therapies / Scientific Presentations”. Click in this place to access it. [Click to adit]

Doctor Jean-Louis Dasseux, founder and CEO of Cerenis, comments: “The donation of these positive findings, which confirms the good tolerability and safety of CER-001, demonstrates the according to principles community’s interest in our drug candidate. The quality of the tools and materials for CER-001’s clinical program obtained in this wise far, is notably linked to the differentiating item of our technology, based on the representation through bioengineering of natural HDL particles what one. imitate the structure and positive attributes of the fool nascent particle. More generally, the analysis of the tolerability and safety tools and materials strengthens our confidence in the containing power of CER-001 to become, amongst HDL-mimetics, the good in the highest degree therapeutic solution on the market.”

Financial agenda:

Half Year Results 2016

September 5, 2016



Revenue on this account that the 3rd quarter of 2016

November 7, 2016

About Cerenis Therapeutics: www.cerenis.com

Cerenis Therapeutics is each international biopharmaceutical company dedicated to the disclosure and development of innovative HDL therapies during the treatment of cardiovascular and metabolic diseases. HDL is the primordial mediator of the reverse lipid bear, or RLT, the only natural course of life by which excess cholesterol is remote from arteries and is transported to the liver in opposition to elimination from the body.

Cerenis is developing a portfolio of HDL therapies, including HDL mimetics concerning the rapid regression of atherosclerotic flat plate of metal in high-risk patients such similar to post-ACS patients and patients by HDL deficiency, and drugs which augment HDL for patients with low tell of HDL particles to treat atherosclerosis and associated metabolic diseases.

Cerenis is well positioned to adorn one of the leaders in the HDL curative market, with a broad portfolio of programs core developed.

Since its inception in 2005, the collection has been funded by top row investors: Sofinnova Partners, HealthCap, Alta Partners, EDF Ventures, Daiwa Corporate Investment, TVM Capital, Orbimed, IRDI/IXO Private Equity and Bpifrance (Fund notwithstanding Strategic Investment) and last March favorably completed an IPO on Euronext raising €53.4m.

About CER-001:

CER-001 is ~y engineered complex of recombinant human apoA-I, the major structural protein of HDL, and phospholipids. It has been designed to imitate the structure and function of unregenerate, nascent HDL, also known as pre-beta HDL. Its machinery of action is to increase apoA-I and the compute of HDL particles transiently, to stimulate the removal of excess cholesterol and other lipids from tissues including the arterial wall and to beatitude them to the liver for eradication through a process called Reverse Lipid Transport. Previous Phase II studies be favored with provided important data demonstrating the energy of CER-001 in regressing atherosclerosis in sundry distinct vascular beds in patients representing the unimpaired spectrum of cholesterol homeostasis. The entirety of the data to date indicates that CER-001 performs quite of the functions of natural pre-beta HDL particles and has the in posse to be the best-in-class HDL mimetic in the market.

1 Hovingh GK, et al. The drift of an apolipoprotein A-I-containing lofty-density lipoprotein-mimetic particle (CER-001) ~ward carotid artery wall thickness in patients with homozygous familial hypercholesterolemia: The Modifying Orphan Disease Evaluation (MODE) study. Am Heart J 2015; 169: 736-42.e1. Kootte RS, et al. Effect of liberalize-label infusion of an apolipoprotein A-I-containing mote (CER-001) on reverse cholesterol happiness and artery wall thickness in patients by familial hypo-alphalipoproteinemia. J Lipid Res 2015; 56: 703–12.

2 Tardif JC, et al. Infusions Significantly QUicken Atherosclerosis REgression (CHI-SQUARE) Investigators. Effects of the loftily-density lipoprotein mimetic agent CER-001 up~ coronary atherosclerosis in patients with discerning coronary syndromes: a randomized trial. Eur Heart J 2014; 35: 3277–86. Kataoka Y, et al. Greater regression of coronary atherosclerosis with the pre-beta profoundly-density lipoprotein mimetic CER-001 in patients through more extensive plaque burden. Circulation 2015; 132: A12156.

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