Date: 2015-09-08
Type of information: Recruitment of the first patient
phase: 2
Announcement: recruitment of the first patient
Company: Cerenis Therapeutics (France)
Product: CER-001
Action
mechanism: protein./HDL-mimetic. CER-001 is a complex of recombinant human ApoA-I and charged phospholipids. It is designed to mimic pre-beta HDL, the \"good\" cholesterol, to promote the removal of excess cholesterol and other lipids from artery walls and enhance reverse lipid transport.
Disease: acute coronary syndromes
Therapeutic area: Cardiovascular diseases
Country: Australia, Hungary, The Netherlands, USA
Trial
details: The CARAT trial is a phase II, double-blind, placebo-controlled, multi-centre study in the USA, Hungary, The Netherlands and Australia and is being led by the South Australian Health and Medical Research Institute (SAHMRI). The novel HDL-mimetic CER-001 will be administered at the dose of 3 mg/kg once a week for 9 weeks for a total of 10 infusions. Patients arriving at hospital with ACS (heart attacks) will receive CER-001 infusions or placebo in addition to standard of care (including lipid lowering drugs such as statins). (NCT02484378)
Latest
news: * On September 8, 2015, Cerenis Therapeutics announced that the first patients have been enrolled into the phase II CARAT trial that is designed to maximize the therapeutic efficacy of CER-001 in post Acute Coronary Syndrome (ACS) patients. The CARAT trial, which began in the 3rd quarter of 2015 as announced to investors at the time of the Company’s IPO, is progressing in line with the defined schedule and its results are expected during the 1st quarter of 2017. The CARAT trial will be followed by a phase III pivotal trial to register CER-001: CALMS. The primary clinical endpoint of the CARAT trial is the percentage change in atheroma volume (PAV) compared with placebo in the trial population with a baseline PAV ≥30%. The primary clinical endpoint of the CARAT trial is the percentage change in atheroma volume (PAV) measured by the change in percentage atheroma volume (PAV) compared with placebo in the trial population with a baseline PAV ≥30% in the coronary artery examined by intravascular ultrasound (IVUS). It is known that even with the best LDLcholesterol (LDL-C)-lowering drugs, patients often experience recurrent cardiovascular events within a few weeks to a few months after the initial event. CER-001 is being used to treat patients in the time period after ACS where the risk of another event is very high. LDL-C lowering drugs generally take far longer to affect mortality and morbidity.
The CARAT trial is headed by Professor Stephen Nicholls, Director of the prestigious Heart Health Research team at the South Australian Health and Medical Research Institute (SAHMRI) and world expert in HDL research through medical imaging. The CARAT Steering Committee consists of world-renowned experts Professors Steve Nicholls (principal investigator SAHMRI), Steven Nissen (Cleveland Clinic, USA), John Kastelein (Academic Medical Center, Amsterdam, Netherlands), Kausik Ray (Professor of Public Health, Department of Primary Care and Public Health, Imperial College London, UK), Gregory Schwartz (Professor of Medicine, University of Colorado, USA), Béla Merkely (Heart and Vascular Center, Semmelweis University, Budapest, Hungary) and Stephen Worthley (Royal Adelaide Hospital, Australia).
