WAYNE, PA — XyloCor Therapeutics, a clinical-stage biopharmaceutical company, recently reported positive 12-month data from the Phase 2 portion of its Phase 1/2 clinical trial (EXACT) designed to assess the safety and provide preliminary evidence of efficacy of lead gene therapy candidate XC001 (encoberminogene rezmadenovec) in patients with refractory angina. At the 12-month mark in the extension period of the trial, XC001 demonstrated durable improvements across multiple efficacy measures, including continued improvement in total exercise duration and reductions in ischemic burden and ischemic symptoms. Earlier this year, XyloCor reported positive results from the primary study period for the Phase 2 portion EXACT trial at six months. New results at 12 months highlight significant, clinically-meaningful impacts that are now sustained out to 12 months, pointing to the potential of XC001 as a novel therapeutic approach for the significant unmet medical need in refractory angina.
“The durability and, in the case of exercise time, continued improvements observed at 12 months signals a sustainable activity which is an exciting step forward in the advancement of gene therapy for cardiovascular disease,” said Thomas Povsic, M.D., Ph.D., Professor of Medicine, Duke University School of Medicine and National Principal Investigator for the EXACT study. “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 candidate designed to reduce ischemic burden by creating new blood vessels in the heart. The six-month primary study period in the Phase 2 portion of the EXACT trial was followed by a month 12 follow up period. At 12 months, patients demonstrated sustained and continued increases in total exercise duration (TED) over baseline, representing a significant and clinically meaningful change. In addition, there was a sustained and robust decrease in episodes of chest pain (angina) and nitroglycerin use. Cardiac imaging at 12 months provided additional evidence of the potential mechanism of action to achieve a biological effect, confirmed by a sustained reduction in ischemic burden observed over time.
“With the 12-month results from our EXACT trial, XyloCor continues to take a lead role in fulfilling the promise of gene therapy for people with cardiovascular disease,” said Al Gianchetti, President and CEO of XyloCor. “These results further enhance our confidence that we are on the right path for transforming outcomes in cardiovascular disease.”
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