Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
XC001 · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Treatment group | EXPERIMENTAL | Administration of study drug (XC001) at the end of the CABG procedure. |
| Placebo group | PLACEBO_COMPARATOR | Administration of A195/placebo at the end of the CABG procedure. |
| Name | Type | Description |
|---|---|---|
| XC001 | DRUG | 22 injections will be administered at the end of the CABG procedure as a one time treatment. |
| A195/placebo | DRUG | 22 injections of A195/placebo will be administered at the end of the CABG procedure. |
Inclusion Criteria: * 1\. Males and females, age 18 to 80 years, inclusive, at the time of signing the ICF. 2\. Has multivessel epicardial CAD and is clinically indicated for coronary revascularization that is best treated via elective (stand-alone, i.e., not associated with valve surgery) and o...
XC001 is an investigational small molecule being studied for the treatment of Coronary Artery Disease (CAD). It is delivered via epicardial injection to promote angiogenesis in patients undergoing coronary artery bypass grafting (CABG). The therapy is currently in Phase 2 clinical development.
XC001 is designed to promote angiogenesis, the formation of new blood vessels, in patients with Coronary Artery Disease. By delivering the therapy directly to the epicardium during CABG surgery, it aims to improve blood flow to the heart muscle. The specific molecular target has not been disclosed.
XC001 is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker YCBD. The company is conducting a Phase 2 clinical trial of XC001 in the United States for patients with Coronary Artery Disease.
XC001 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 2 trial is a randomized, double-blind, placebo-controlled study with an enrollment target of 116 participants.
XC001 is being evaluated in a single Phase 2 clinical trial registered as NCT07118449. The study, titled 'Epicardial Delivery of XC001 Gene Therapy to Promote Angiogenesis in CAD Patients Undergoing Treatment With CABG,' is not yet recruiting and will enroll 116 patients in the United States.
Yes, XC001 is described as a gene therapy in its clinical trial title, despite being classified as a small molecule. The trial involves epicardial delivery of XC001 to promote angiogenesis in patients with Coronary Artery Disease undergoing CABG surgery.