XyloCor reveals promising 12-month data from Phase 2 Trial of XC001

XyloCor Therapeutics, a clinical-stage biopharmaceutical company focusing on novel gene therapies for cardiovascular diseases, has revealed encouraging 12-month data from the Phase 2 section of its Phase 1/2 EXACT trial.

The trial is evaluating the safety and preliminary efficacy of its lead gene therapy candidate, XC001 (encoberminogene rezmadenovec), in refractory angina patients. The data show XC001 brought about enduring enhancements across several efficacy measures, including total exercise duration and reductions in ischemic symptoms and burden.

Earlier this year, XyloCor reported positive outcomes from the Phase 2’s primary study period at six months. The recent 12-month data from the trial’s extension period shows sustained, clinically-significant impacts, suggesting the potential of XC001 as a new treatment approach for the significant unmet medical need in refractory angina.

Thomas Povsic, Professor of Medicine at Duke University School of Medicine, and National Principal Investigator for the EXACT study, said, “These 12-month data build upon the positive results achieved at the 3- and 6-month marks of the trial. In total, the outcomes of the EXACT study form a robust body of mechanistic evidence to propel the next stage of XC001’s development, suggesting that a single treatment may have long-term benefit.”

XC001 is a one-time gene therapy designed to decrease ischemic burden by stimulating new blood vessel formation in the heart. At 12 months, the patients showed sustained and increased total exercise duration over the baseline, pointing to a significant and clinically meaningful change. Furthermore, episodes of chest pain and nitroglycerin use were markedly reduced.

Al Gianchetti, President and CEO of XyloCor, remarked, “These results further enhance our confidence that we are on the right path for transforming outcomes in cardiovascular disease.”

XC001 aims to form new blood vessels in the heart to bypass diseased vessels and improve blood flow, potentially enhancing patients’ quality of life by allowing them to engage in daily physical activities that would otherwise cause pain.