HELSINKI, March 12, 2026 (GLOBE NEWSWIRE) — Aplagon, a clinical stage biotech pioneering a first-in-class treatment for thrombo-inflammatory diseases, known as APAC, a heparin proteoglycan mimetic with antiplatelet and anticoagulant effects, announced today the first patient has been dosed in its Phase 2a ‘HEALING’ clinical trial in peripheral arterial occlusive disease (PAOD) leading to chronic limb threatening ischemia (CLTI).
The single- and repeat- dose study using an intravenous (IV) administration taking place in Finland, is for up to 42 patients across 4 cohorts and has been designed to provide a preliminary indication of safety and efficacy of APAC in CLTI patients (with and without revascularisation) as well as APAC’s effect on thrombo-inflammatory biomarkers. Atherosclerosis-related thrombo-inflammation lead to CLTI, a severe form of PAOD, with insufficient blood flow in the affected limb, which can indicate limb amputation and has a mortality rate of 25% in the first year. The most important risk factors are diabetes and cigarette smoking.
This new Phase 2a trial received FIMEA approval following the successful completion of an international Phase 1 clinical trial in 30 healthy participants, which demonstrated that APAC was well tolerated, with dose-dependent and transient systemic antithrombotic effects. An associated PET-imaging clinical trial with 89zirconium-labeled APAC in PAOD patients and healthy participants is due to complete in H1 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, MD, PhD at Helsinki University Hospital, University of Helsinki, commented on the study, “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. 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.”
PAOD is relatively common and, as it progresses, can lead to limb threatening ischemia, significantly increasing the risk of amputation if arterial perfusion is not improved by a revascularization procedure. Arterial occlusions are often caused by atherosclerotic plaque formation, which may be aggravated by platelet aggregation at sites of severe stenosis, worsening limb ischemia. Current treatments for PAOD do not cure the disease but only alleviate symptoms. Revascularization procedures are often effective; however, particularly after endovascular treatment, restenosis occurs in approximately one-third of treated arteries, even when patients are on antithrombotic medication according to current treatment guidelines. The occurrence of restenosis and microvascular dysfunction represent a significant Achilles’ heel of endovascular treatment, leading to not only suffering for patients but also considerable societal costs.
Aplagon is also planning for 2026 a Phase 2 clinical trial for arteriovenous fistula (AVF) maturation failure in Europe, following the successful completion of its Phase 1 AVF trial. The study demonstrated encouraging early maturation results with no safety concerns.
About Aplagon Oy
Aplagon is a clinical stage biotech company developing a first-in-class therapeutic, called APAC (anti-platelet and anticoagulant), for treating thrombo-inflammatory diseases. The company’s two lead indications are for the prevention of arteriovenous fistula (AVF) maturation failure, to enable lifesaving haemodialysis treatment in end-stage kidney disease patients, and for chronic limb threatening ischemia (CLTI). By mimicking naturally occurring mast cell-derived heparin proteoglycans, APAC targets arterial injury sites providing long-lasting antithrombotic and anti-inflammatory action in situ. APAC is intended for in-hospital use and can be administered either locally or by IV infusion.
APAC is based on the pioneering research on mast cell-derived heparin proteoglycans performed by Prof. Riitta Lassila and associates at Wihuri Research Institute in Helsinki, Finland. Aplagon is backed by a syndicate of leading Nordic investors including FSG Fund, Wihuri Foundation, Innovestor and Serlachius Foundation as well as EIC Fund. The company is headquartered in Helsinki, Finland.
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Media Contacts
Aplagon
Aki Prihti, CEO
aki.prihti@aplagon.com
Scius Communications
Katja Stout +44 7789435990
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Daniel Gooch +44 7747875479
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