MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers

DL-VSU-201 is a multi-center, two-part study in patients with VSU (n=80). The lead-in phase of the study (Part 1) enrolled 11 eligible patients. In Part 1, patients were allocated to receive active MTX-001 once weekly or once every two weeks with standard of care. After completion of Part 1, the data was reviewed to determine the administration frequency of Study Product in Part 2 of the Study. In Part 2, approximately 70 patients will be randomized 1:1 to receive MTX-001 or placebo (0.9% NaCl) with standard of care. Patients will be administered study treatment weekly, as needed. Patients will receive localized subcutaneous injection of MTX-001 or placebo into and/or around the wound bed during weekly clinic visits over a 12-week period and assessed for safety and efficacy measures at Screening, Baseline, and Weeks 4, 8, and 12. Percent reduction of the wound surface area will be formally collected at Baseline, Weeks 4, 8, and 12. To assess healing, the ulcer will be evaluated by assessing the change in the surface area from Baseline. Overall change in VAS from Baseline to Week 12 will be evaluated and total wound closure will be evaluated at Week 12.