Aplagon has dosed the first patient in its phase 2a HEALING clinical trial evaluating APAC, a first‑in‑class treatment for thrombo‑inflammatory diseases, in people with peripheral arterial occlusive disease and chronic limb threatening ischemia.
The study, taking place in Finland, will enrol up to 42 patients across four cohorts and will assess the safety and preliminary efficacy of APAC delivered intravenously. It will also examine the therapy’s impact on thrombo‑inflammatory biomarkers in patients with and without revascularisation.
CLTI is a severe form of PAOD caused by atherosclerosis‑related thrombo‑inflammation, leading to critically reduced blood flow, a high risk of amputation and a one‑year mortality rate of 25 percent.
The phase 2a trial follows a successful international phase 1 study in 30 healthy volunteers, which showed APAC was well tolerated with dose‑dependent and transient systemic antithrombotic effects. A related PET‑imaging study using 89zirconium‑labelled APAC is expected to complete in the first half of 2026.
Aki Prihti, CEO at Aplagon, said: “We’re delighted to have achieved this significant clinical milestone and dosed our first patient in our phase 2a trial to treat PAOD/CLTI. These are common, serious, thrombo-inflammatory diseases with high morbidity.
“Our innovative approach, using a heparin proteoglycan mimetic with targeting ability and retention on the vascular injury sites, has potential applications across a broad range of serious vascular diseases caused by thrombo-inflammation. Importantly, our APAC technology can be easily administered locally or intravenously in the hospital setting, supporting its uptake by vascular surgeons or angiologists.”
Maarit Venermo, Professor of vascular surgery at Helsinki University Hospital, explained: “The aim of this study is to improve the current treatment of PAOD/CLTI. APAC has been shown to prevent platelet aggregation and blood clotting. Previous studies have also shown that it reduces the inflammatory response in tissues damaged by oxygen deprivation during short follow-ups.”
He added: “Through these actions, APAC enhances the medical treatment of lower limb arterial atherosclerosis, accelerate the healing of tissue damage caused by ischemia, and prevent restenosis after revascularization procedures, thereby reducing the need for reinterventions.”
Aplagon also plans a phase 2 trial in 2026 for arteriovenous fistula maturation failure in Europe, following encouraging phase 1 results.
