This is a 26-week (with a 26-week extension) multicenter, randomized, double-blind, placebo-controlled Phase 2 study of XC001 versus placebo. Approximately 116 participants who have CAD and have been referred for revascularization by CABG and who have, according to assessment by stress imaging multiple myocardial segments that are substantially ischemic, and that are unlikely to be fully revascularized during CABG for technical reasons, including diffuse atherosclerosis, lack of conduits, or insufficient target vessels.
Patients will be randomized in a 1:1 to XC001 or placebo injections during the final stages of the CABG procedure. Patients will have a baseline CMR at day 4-6 post CABG and additional assessments in the primary study period will be performed on Day 14, and Weeks 4, 12, and 26, (and during the extension period at 52 weeks).
1. Males and females, age 18 to 80 years, inclusive, at the time of signing the ICF.
Postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to screening. In addition, at least 2 high follicle stimulating hormone (FSH) measurements in the postmenopausal range must be used to confirm a postmenopausal state in women with less than 12 months of amenorrhea and not using hormonal replacement surgery; OR
Surgically sterile (i.e., hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) at least 1 month prior to Screening 6. Female participants agree to not donate oocytes and male participants must agree not to donate sperm for 6 months following administration of investigational protocol.
ST elevation myocardial infarction (STEMI) or cerebral vascular accident within the past 60 days prior to the Screening visit;
Sustained, current systolic blood pressure (BP) less than 90 mmHg or uncontrolled hypertension (systolic BP > 180 mmHg, diastolic BP > 100 mmHg) despite maximal medical treatment;
Current untreated malignant ventricular arrhythmia;
Congestive heart failure (HF) within the last 60 days defined as New York Heart Association Functional Class IV;
Parallel
XC001
Drug22 injections will be administered at the end of the CABG procedure as a one time treatment.
A195/placebo
Drug22 injections of A195/placebo will be administered at the end of the CABG procedure.
Change from Baseline (Day 4-6 CMR) in treated segment(s) comparing XC001 and placebo in CMR imaging parameters at Weeks 12 and 26 post-surgery.
Endpoint at the participant level is the proportion of qualifying segments that improve at 12 and/or 26 weeks as determined by myocardial ischemic burden, as measured by the following: * Global and segmental perfusion measured as sum of 32 subsegmental American Heart Association (AHA) LV segments with myocardial ischemia at 12- and 26-weeks follow-up compared to baseline (defined as a subsegment with myocardial ischemia without subendocardial late gadolinium enhancement) * Segmental myocardial blood flow measuring extent of ischemic defect in each of 16 (combined subendocardial and subepicardial) AHA LV segments defined as below at 12 and 26 weeks follow-up compared with Baseline: * Segment is abnormal if one (subendocardial) or both subsegments are ischemic at Baseline * Segment is defined as improved at follow-up if one or both subsegments normalize To qualify for analysis of the primary endpoint, at least 3 of 32 subsegments will have will have to be ischemic on the baseline CMR.
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