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Encoberminogene rezmadenovec is an investigational gene therapy. It is also known by its development code XC001. The substance is classified as a structurally diverse substance of non-chemical origin, and it belongs to the therapeutic area of cardiovascular diseases.[1] It has no marketing authorisation in the product records, meaning it is not yet approved as a medicine.[1] The product is supplied by Xylocor Therapeutics Inc.[1]
The registry records do not describe the molecular mechanism of action of encoberminogene rezmadenovec. The trials investigate whether a single injection into the heart muscle can reduce the amount of heart muscle that lacks sufficient blood supply (ischemic burden) and improve exercise capacity in people with angina. The exact way the gene therapy achieves this is not detailed in the available trial records.
Encoberminogene rezmadenovec is formulated as a solution for injection and is given by intracardiac use, meaning it is injected directly into the heart muscle.[1] In the EXACT-2 trial, the dose used is 2.2 millilitres delivered via a catheter during a one-time endocardial administration.[1] The EXACT-CABG trial also uses a 2.2 millilitre dose by intracardiac use.[2]
Two Phase 2 trials of encoberminogene rezmadenovec are registered in the EU Clinical Trials Information System. Both are interventional studies. The EXACT-2 trial is authorised and plans to enrol 109 participants with refractory angina.[1] The EXACT-CABG trial is completed and enrolled 116 participants undergoing coronary artery bypass grafting who are at risk of incomplete revascularization.[2]
The EXACT-2 trial compares XC001 against a sham procedure. Its primary endpoint, measured at Week 12 and Week 26, combines three elements: total exercise duration on a treadmill test, the number of angina episodes recorded in a patient diary, and ischemic burden measured by stress imaging with positron emission tomography (PET).[1] The EXACT-CABG trial compares XC001 against placebo. Its primary endpoint is the change in treated heart segments on cardiac magnetic resonance imaging (CMR), specifically the proportion of qualifying segments that improve at 12 and/or 26 weeks after surgery, based on myocardial ischemic burden and left ventricular contractile function.[2]
No results from either trial are reported in the registry records. The EXACT-2 trial is authorised but not yet completed; the EXACT-CABG trial is completed but its findings are not included in the data provided.
The registry records do not include information on side effects of encoberminogene rezmadenovec. No supplementary sources on adverse events were provided, so no side effect profile can be described here.
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