XyloCor Therapeutics has reported positive topline data from the Phase II portion of its Phase I/II EXACT clinical trial of XC001 (encoberminogene rezmadenovec) gene therapy for refractory angina.
The open-label, multicentre, single-arm Phase I/II trial has been designed for evaluating the efficacy and safety of XC001 in these patients.
XyloCor stated that the trial met both its safety and efficacy objectives, with no serious adverse events related to the drug reported.
The company obtained six-month data from 28 participants in the study’s Phase II portion, which demonstrated improvements in many important efficacy measures such as reduction in ischaemic burden measured by cardiac positron emission tomography (PET) imaging.
Participants also had improvements in total exercise duration, along with a reduction in episodes of chest pain.
After six months of treatment, almost half of the participants were able to complete ordinary physical activity without causing angina.
XyloCor president and CEO Al Gianchetti said: “We are excited to share this positive topline data from the Phase II portion of the EXACT trial, reinforcing our confidence in XC001 as a novel therapeutic approach with the potential to address the significant unmet medical needs of people with refractory angina.
“We now look forward to pursuing key upcoming milestones in XC001’s continued development, including finalising our pivotal trial design through our ongoing discussions with the FDA and other regulatory authorities.”
The XC001 gene therapy has been designed for promoting new blood vessels in the heart which will bypass diseased blood vessels and helps improve blood flow.
It is intended to eliminate toxicity issues that are observed with other gene therapies by a strategy of a one-time, local administration.
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