Company expects to start Phase II trials with HDL mimetic during late 2010.
Cerenis Therapeutics raised €40 million (about $51.8 million) in the first close of its Series C round of financing and separately reported the award of €10.7 million (about $13.9 million) in French government funding to support development of its Phase II-stage HDL mimetic, CER-001. The Series C fundraising will also be used to progress CER-001 and was led by France-based Fund for Strategic Investment, a new investor that put €20 million (just shy of $26 million) into Cerenis.
The French government award has been made through OSEO to Cerenis and Novasep, its process development partner for CER-001. The funds will be used to support continued development of the HDL therapy for orphan diseases. The government award coincided with Cerenis expanding its existing agreement with Novasep for production of CER-001. The latter now has global responsibility for manufacturing the product through clinical trials to initial commercial-scale supply.
Cerenis is focused on the discovery and development of HDL therapies for the treatment of cardiovascular and metabolic diseases. CER-001 is an HDL mimetic based on natural apolipoprotein A-I (ApoA-I), the major structural protein of HDL. The product is in development both as an infusion therapy to help regress plaques in patients with acute coronary syndromes (ACS) and for the treatment of orphan lipid metabolism diseases. A Phase I trial has already been successfully completed and was reported in May. A Phase II trial in post-ACS patients is expected to start during late 2010.
Cerenis’ clinical pipeline also includes CER-627, a fixed-dose combination of niacin and aspirin that is designed to deliver the aspirin dose by sustained release several hours before the niacin dose. The product is currently in Phase II evaluation. CER-002 is a specific agonist for human PPAR delta that has completed a Phase I trial. The candidate was selected from a series of small molecule compounds available through a licensing agreement with Nippon Chemiphar. Cerenis says it is currently exploring potential development of the drug for several orphan indications.