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GEN News Highlights : Oct 21, 2010

Cerenis Closes Series C Financing with €50M

Company’s HDL mimetic pipeline is led by a candidate for ASC in Phase II.

Cerenis Therapeutics raised €10 million (almost $14 million) in a second close of its Series C financing. This takes the total Series C funding to €50 million (about $70 million).

The capital will support Phase II development of the lead program, CER-001, an HDL mimetic for the treatment of cardiovascular diseases. It will also support the development of other HDL therapies.

CER-001 is an HDL mimetic and is based on natural apolipoprotein A-I (ApoA-I), the major structural protein of HDL. It is designed to regress atherosclerotic plaque. A Phase I study in acute coronary syndrome (ASC) patients was completed in May. Cerenis is also developing CER-001 for metabolic diseases, specifically as a treatment of orphan diseases in the lipid metabolism field.

The ASC trial was a randomized, double-blind, placebo-controlled, cross-over, single rising dose study. It involved 32 dyslipidemic volunteers and showed that the drug was safe and well tolerated at dosages of up to 45 mg/kg. The study also demonstrated cholesterol mobilization at dose levels of 2 mg/kg and higher. A Phase II trial using intravascular ultrasound to assess plaque regression in post-ACS patients is planned for initiation later this year.

The company has another HDL mimetic IV infusion candidate called CER-522, which is based on a peptide analogue of ApoA-I. It is currently in Phase I development for the treatment of aortic valve stenosis.

Cerenis also has a Phase I, a Phase II, and a preclinical oral product in development, all for the treatment of dyslipidemia with low HDL. CER-627, which is at the Phase II stage, is a fixed-dose combination of niacin and aspirin, where the aspirin dose is delivered by sustained release several hours before the niacin dose. In a proof-of-concept clinical study a 39% flushing reduction compared to Niaspan, the market leader, was observed.

Additionally, CER-628 is being developed as a statin/niacin/aspirin follow-up compound to CER-627. Cerenis is currently conducting preclinical investigations. The combination is expected to combine the attributes of CER-627 of enhancing HDL levels and reducing flushing with the LDL-lowering properties of a statin.

In Phase I development is CER-002, which was developed from NCEs that are specific agonists for human PPAR delta. It was selected from a series of small molecule compounds available to Cerenis through a licensing agreement with Nippon Chemiphar. Cerenis says that it is exploring several orphan drug indication development pathways.

In preclinical models CER-002 demonstrated strong efficacy in elevating HDL and in halting the progression of atherosclerosis. It also completed Phase I trials demonstrating that the product is well tolerated and safe at all doses tested.