XyloCor Therapeutics presented positive results from the Phase 2 portion of its Phase 1/2 EXACT clinical trial of its lead gene therapy candidate, XC001, for the treatment of refractory angina at the European Society of Cardiology Congress.
Dr. Thomas Povsic, principal investigator of the EXACT trial, presented primary six-month outcome data from the recently completed EXACT trial, which demonstrated that treatment with XC001 resulted in improvements across all key efficacy endpoints. The findings underscore its strong potential as a novel therapeutic approach for the treatment of this disabling condition.
XC001 is a one time gene therapy designed to reduce ischemic burden by creating new blood vessels in the heart through the local expression of multiple vascular endothelial growth factor isoforms.
In the Phase 2 portion of the EXACT trial, 32 patients with class II-IV angina were dosed with the maximal dose of XC001 through direct administration to the heart. XC001 met all of its safety and exploratory objectives and showed potential transformative benefits for the patient population.
“The six-month results from the EXACT trial, which have now been sustained out to 12 months, demonstrate that gene therapy with XC001 has the potential to be safely administered while improving quality of life for these cardiac patients,” Dr. Povsic said in a statement.
Al Gianchetti, president and CEO of XyloCor, said these results “strongly support our continued development of this novel therapeutic approach.”