Results from a phase II study in patients who underwent percutaneous revascularisation of the superficial femoral artery (SFA) and received the IL-1a True Human monoclonal antibody (MABp1, XBiotech) have shown a 58% reduction in major adverse cardiovascular events (MACE) and 60% longer patency in treated vessels compared to control patients.
The phase II clinical study of MABp1 is a randomised, open-label multicentre trial lead by Hosam El-Sayed, assistant professor of Cardiovascular Surgery, Weill Cornell Medical College, Methodist DeBakey Heart and Vascular Center, The Methodist Hospital, Houston, Texas, USA.
Patients enrolled in the study had claudication or calf pain at rest and haemodynamically significant occlusion of the SFA, with average lesion lengths of 15cm. The primary efficacy endpoint, measured by vessel patency, evaluates the ability of MABp1 to reduce restenosis by blocking vascular inflammation after revascularisation using balloon angioplasty, atherectomy or stent placement. The incidence of MACE was the secondary endpoint based on the high incidence of cardiovascular-related morbidity and mortality in patients requiring revascularisation of the femoro-politeal artery.
XBiotech reported that at the time of the interim analysis, 42 patients had enrolled in the study—including 21 patients in the control arm receiving standard of care (SOC) and 21 patients in the treatment arm receiving SOC and MABp1. Patients were treated with MABp1 and evaluated for 12 months. Adverse events reported in both groups appeared to be related to underlying disease, and no obvious side effects from MABp1 treatment were observed.
“The challenge we face in endovascular surgery today is keeping vessels open after being treated by endovascular interventions,” said El-Sayed. “While the emerging technology drug–eluting stents and balloons have helped to address the high rate of restenosis, they are limited to local delivery of drugs within the vessel. As a systemic drug, MABp1 is capable of addressing both restenosis within the vessel, as well as the underlying cardiovascular and cerebrovascular complications associated with vascular disease. This represents an entirely new treatment approach and a paradigm shift in current thinking. Based on the encouraging interim results, incorporating this simple and safe monoclonal antibody therapy into current treatment practices has the potential to provide significant benefit to patients and a new option for endovascular surgeons.”
“Vascular inflammation is the cause of vascular diseases such as atherosclerosis,” said Michael Stecher, medical director, XBiotech. “Our MABp1 therapy blocks a key mediator of vascular inflammation. Patients with advanced arterial disease treated with MABp1 after revascularisation have shown reduced arterial occlusion and reduced overall complications from the disease. Based on the interim results, we believe MABp1 may ultimately provide a treatment for millions of patients suffering with vascular disease.”
About True Human antibodies
True Human antibodies represent the next generation of therapeutic antibodies. These antibodies are identified using XBiotech’s proprietary platform technology to ensure faithful reproduction of the original human antibody gene. True Human antibodies are “invisible” to the body’s immune system and thus have the potential for better safety, efficacy and patient tolerability compared to earlier generation antibody therapeutics.