XyloCor Therapeutics has dosed the first subject in the multi-centre, randomised Phase IIb EXACT-2 trial, to assess the gene therapy candidate, XC001 (encoberminogene rezmadenovec), for patients with coronary artery disease and refractory angina.
Dosing procedures were carried out by Timothy Henry at The Christ Hospital Health Network in Cincinnati, Ohio, US.
The double-blind study involves 100 subjects with refractory angina to assess the gene therapy's efficacy and safety delivered via SmartWise’s Extroducer Infusion Catheter System that allows for direct injections of therapies into the heart muscle.
This dosing marks a significant milestone in the development of XC001, following outcomes from the Phase I/II EXACT-1 trial.
The trial indicated the therapy’s potential to modify the disease course, showing a decrease in cardiac ischemia and anginal symptoms, and an improvement in the quality of life for cardiac subjects without other treatment options.
Findings from this study showed that the therapy could be administered safely, leading to durable clinical improvements. These included increased exercise duration, minimised ischemic load as per positron emission tomography (PET) imaging measurements, and a decrease in angina frequency.
A significant percentage of subjects reported no chest pain with ordinary activities at the six-month mark, without any serious adverse events related to the therapy being reported.
XyloCor Therapeutics CEO and president Albert Gianchetti said: “Initiating the EXACT-2 trial is an important milestone as we continue to develop XC001 for the treatment of refractory angina in patients who have exhausted available treatment options and have a debilitating quality of life.
“Building on the positive results from EXACT-1, we are now focused on advancing the EXACT-2 trial to bring this potentially transformative treatment to patients as quickly as possible.”
In addition to the EXACT-2 trial, XyloCor is commencing a double-blind Phase II trial of the therapy as an adjunctive treatment to coronary artery bypass graft surgery (CABG).
In June 2022, the Extroducer Infusion Catheter System received 510(k) clearance from the US Food and Drug Administration (FDA).
Last year, XyloCor entered a licensing agreement with SmartWise to utilise the system for XC001 delivery.
