Aplagon Announces Review Publication On APAC, A First-In-Class Dual-Action Antithrombotic To Treat Unmet Clinical Needs In Thromboinflammatory Diseases

(MENAFN- GlobeNewsWire - Nasdaq) HELSINKI, June 01, 2026 (GLOBE NEWSWIRE) -- Aplagon, a clinical-stage biotech developing first-in-class therapies for thromboinflammatory diseases, today announced the comprehensive publication of an invited review article in Arteriosclerosis, Thrombosis, and Vascular Biology (ATVB).

The paper highlights 1) a central clinical challenge in achieving effective arterial thrombosis prevention without compromising hemostatic safety and 2) summarises the preclinical and clinical evidence supporting APAC, a first-in-class heparin proteoglycan mimetic, which combines selective antiplatelet and anticoagulant activity in a single agent. Professor Riitta Lassila, Chief Scientific Officer and Chief Medical Officer at Aplagon, is the leading author of the publication alongside colleagues from the University of Helsinki and Helsinki University Hospital (HUS).

Thromboinflammatory cardiovascular conditions driven by thrombosis and vascular occlusion remain a leading global cause of morbidity and mortality. Current standard-of-care treatments rely on combinations of two separate classes of antiplatelet and anticoagulant drugs to treat severe ischemic events, but these approaches are only partially effective and limited both by variable patient responses and increased bleeding risk.

APAC overcomes the limitations of current therapies by integrating inhibition of both platelet activation (via collagen and thrombin only) and thrombin generation within a single molecule. This duality aligns with a short systemic half-life but a targeted and long-term retention at vascular injury sites. This mode of action relies on modulation of von Willebrand factor and thrombin activities. Subsequently, the inflammation at local injury sites is alleviated during and after interventions including vascular surgery and progressing atherosclerosis.

APAC is expected to provide superior efficacy over the standard of care, due to its comprehensive properties that address the underlying causes of the disease, including at the same time alleviating thrombosis risk, inflammation and supporting blood-vessel wall healing.

"There is a clear need for more precise antithrombotic strategies that reflect the biology of thrombotic complications under different blood flow conditions and clinical demands, such as in association with vascular interventions and recovery,” said Professor Riitta Lassila, lead author and CSO and CMO at Aplagon.“APAC is designed to act locally where arterial thrombosis occurs, while preserving global hemostatic properties. This publication, together with the growing body of clinical evidence, supports the potential of APAC as a new class of antithrombotic therapy,” she added.

Aki Prihti, CEO at Aplagon, said,“This compelling paper demonstrates the substantial progress we have made with our APAC platform and is a major credit to Riitta and colleagues. Our goal is to deliver targeted, biology-driven therapies that act locally at the vascular injury sites to inhibit thrombosis and inflammation and support vascular wall healing. APAC represents a potential first-in-class therapy in our lead indications, including arteriovenous fistula maturation (AVF) failure and peripheral arterial occlusive disease / chronic limb threatening ischemia (PAOD/CLTI) aiming at improving blood circulation.”

Preclinical models demonstrate targeted dual action at sites of vascular injury

APAC binds directly to exposed VWF at the sites of vascular injury to inhibit VWF-mediated platelet aggregation and thrombin-driven fibrin formation while allowing platelet adhesion and hemostasis to take place. APAC is particularly active under high shear rate blood flow conditions, triggered by platelet deposition in arterial thrombosis, where traditional heparins often fail due to the neutralizing action against heparin via platelet activation. The following preclinical experimental results reinforce APAC's mode of action as listed above:

• Arterial thrombosis models: Potent inhibition of platelet and fibrin deposition under high-shear arterial flow conditions, dependent on von Willebrand factor.
• Atherosclerosis: Extensive reduction in plaque formation, necrotic areas and inflammatory indicators, especially under high-shear rate stenotic areas.
• Ischemia–reperfusion injury: Significant protection against irreversible acute kidney and cardiac injury, with significant reductions in tissue damage and associated inflammatory signatures.
• Stroke model: Reduced ischemic brain injury without increased hemorrhagic risk.
  

Collectively, these findings provide strong support for APAC's clinical development programs in AVF maturation failure as well as in PAOD/CLTI, and more broadly across cardiovascular and vascular intervention settings.

Clinical progress and development path

Early clinical trials have already demonstrated favourable safety and tolerability with both systemic (IV) and local administration of APAC. A Phase 2a clinical study is currently underway focusing on PAOD/CLTI and a Phase 2 study is planned in the AVF indication. These indications reflect areas of high clinical need where current treatment options are suboptimal, and the unique modes of APAC action could offer first-in-class solutions.

The project was supported by funding from Aplagon and the European Innovation Council (EIC grant 190168043).

Reference:
Kern AY, Jouppila A, Pitkänen H, Lassila R. Therapeutic strategies combining antiplatelet with anticoagulant actions: heparin proteoglycan mimetic APAC as a model. Arteriosclerosis, Thrombosis, and Vascular Biology (ATVB), 28 May 2026.

About Aplagon Oy

Aplagon is a clinical-stage biotechnology company developing APAC, a first-in-class antiplatelet and anticoagulant therapy for treating thromboinflammatory diseases. The company's lead programmes are for the prevention of arteriovenous fistula (AVF) maturation failure, to enable lifesaving hemodialysis treatment in end-stage kidney disease patients, and for chronic limb threatening ischemia (CLTI) , with broader applications across cardiovascular and vascular intervention settings. 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, creating flexibility across multiple clinical settings.

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 Fåhraeus Startup and Growth AB and the European Innovation Council. The company is headquartered in Helsinki, Finland.

For more information see our website and LinkedIn.

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