Cerenis Therapeutics, a biopharmaceutical company focused on discovering and developing novel HDL therapies, today announced the completion of a Phase 1 study of the Company's CER-001 investigational product candidate to treat patients with acute coronary syndromes. Results of the completed study provide evidence that the investigational therapy was safe and well-tolerated at all dose levels evaluated, including those intended for future clinical development.
“The data are strongly supportive of continued clinical development of CER-001 as a treatment for patients with high-risk atherosclerosis, including acute coronary syndromes.”
The Phase 1 randomized, double-blind, placebo-controlled, cross-over, single rising dose study of 32 healthy dyslipidemic human volunteers, was designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single intravenous infusions of CER-001. In this study, each subject received dosages up to 45 mg/kg and placebo in a two period crossover design. No drug related adverse events were reported for CER-001, and cholesterol mobilization was observed at dose levels of 2mg/kg and higher.
The results from this study were consistent with pre-clinical findings in demonstrating evidence of dose-related cholesterol mobilization, as well as evidence of substantial increases in HDL-cholesterol levels. Because of these properties, we believe that administration of CER-001 may promote reverse cholesterol transport and stimulate cholesterol removal in patients.
"These positive results represent an important milestone for the CER-001 program and Cerenis' approach to developing potent HDL mimetics." said Jean-Louis Dasseux, CEO of Cerenis. "The data are strongly supportive of continued clinical development of CER-001 as a treatment for patients with high-risk atherosclerosis, including acute coronary syndromes."
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