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HDL mimetic failed to achieve primary endpoint in CHI-SQUARE study
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Cerenis Therapeutics has announced that its investigational HDL mimetic did not reach the primary endpoint in patients with ACS enrolled in the phase 2b CHI-SQUARE study.
The double blind, randomized, dose-ranging study was conducted to evaluate the efficacy and safety of CER-001. Researchers, led by principal investigator Jean-Claude Tardif, MD, of the Montreal Heart Institute, recruited 507 patients with ACS at 53 centers in the United States, Canada, France and the Netherlands. Patients were randomly assigned in a 3:1 ratio to receive weekly infusions of placebo or a low, middle or high dose of CER-001 for 6 weeks. IVUS was performed at baseline at 3 weeks after the final dose, according to a press release.
Jean-Claude Tardif
The primary endpoint was nominal change to total atheroma volume among CER-001 vs. placebo recipients in the 417-patient modified intention-to-treat population. While CER-001 recipients experienced a significant reduction in total atheroma volume as compared with baseline, and researchers observed a dose-dependent cholesterol mobilization among post-ACS patients, the difference between the two groups was not significant, according to the release.
In an independent, blinded analysis performed by Stephen Nicholls, MBBS, PhD, of the South Australian Health and Medical Research Institute, the reduction in total atheroma volume vs. baseline in the modified intention-to-treat population was also significant, but did not reach significance when compared with placebo for the primary clinical endpoint. In the modified per-protocol population (n=295), one dose level of CER-001 achieved significantly better total atheroma volume and percent atheroma volume change vs. placebo.
Stephen Nicholls
“The apparent demonstration of benefit at one dose level versus placebo in our analysis is encouraging,” Nicholls stated in the release. “CER-001 warrants further study in clinical trials to evaluate its potential benefits for patients with CVD.”
CER-001 is an engineered complex of recombinant human apoA-I and phospholipids. It was designed to mimic the structure and function of pre-beta HDL. CHI-SQUARE is the largest clinical trial to date to test an HDL mimetic, according to the company.
“In all preclinical and clinical studies to date, CER-001 has been shown to perform the functions of natural HDL and the steps of the reverse lipid transport pathway with a high degree of potency,” Cerenis Therapeutics CEO Jean-Louis Dasseux, PhD, MBA, stated in the release. “We are undertaking a detailed review of all the data to further understand these results and to determine the best path forward for CER-001.”
The company anticipants that full results from the CHI-SQUARE study will be presented at a future scientific meeting.