Peripheral arterial occlusive disease (PAOD) is a serious chronic cardiovascular condition associated with high mortality, morbidity, and limb amputation rates. PAOD is caused by atherosclerosis, which together with inflammation and thrombosis (blood clot formation) leads to impaired and eventually full occlusion of blood flow to the lower limbs. Funded by the European Innovation Council, the APAC-ON project is introducing a novel drug that uniquely targets these atherosclerotic sites, provides a local, long-term antithrombotic and anti-inflammatory effect, and may inhibit further atherosclerosis. APAC-ON will evaluate the safety and efficacy of the drug in patients with advanced PAOD.
There is a major unmet need for effective and safe therapies for PAOD due to the high cardiovascular burden, including mortality, morbidity, and amputation rates in these patients. Aplagon is developing the first vascular injury -targeting product (APAC) for the local treatment of advanced PAOD. PAOD is caused by fatty deposits in lower limb arteries (atherosclerosis) that become inflamed (thrombo-inflammation), resulting in blood coagulation (atherothrombosis). APAC uniquely targets the sick arteries, prevents further atherosclerosis, and downregulates thrombo-inflammation, the main drivers of PAOD. At the beginning of the EIC-grant project, Aplagon had completed preclinical proof-of-concept and toxicology studies, initiated a Phase 1 clinical study in hemodialysis access failure indication (local administration) and was preparing for clinical studies in advanced PAOD patients (systemic administration). Aplagon has an experienced, international team, and is supported by a renowned scientific advisory board. The EIC-grant project aims to show the safety and preliminary efficacy of APAC in advanced PAOD-patients, a major value inflection point.