First Patient Dosed in the CHASE Clinical Trial for Aplagon’s APAC Therapeutic for Thrombo-Inflammatory Diseases

  • Company’s heparin proteoglycan mimetic now in three clinical trials

HELSINKI, October 24, 2024.  Aplagon Oy (Aplagon), a clinical stage biopharmaceutical company developing a first-in-class therapeutic (APAC, a heparin proteoglycan mimetic) for thrombo-inflammatory diseases, announced today the first patient had been administered radiolabeled APAC and all three positron emission tomography / computed tomography (PET/CT) imaging sessions have been completed in an open-label PET-imaging study (CHASE-study).

The CHASE-study investigates safety, tolerability, and biodistribution of 89zirconium-labeled APAC in six patients with peripheral arterial occlusive disease / critical limb ischemia (PAOD/CLI) and four healthy volunteers. APAC uniquely combines short systemic half-life and local, long-term effect at the vascular injury sites. The 89Zr-APAC was administered as an intravenous (IV) injection (Day 1), and PET/CT scanning performed on Day 1, Day 3, and Day 7, with the aim to determine 89Zr-APAC’s biodistribution and binding to arteries and atherosclerotic lesions. The study, performed in the Netherlands, will provide valuable information on both systemic and local pharmacokinetics of a low APAC dose after IV-administration. The CHASE-study is supported by a EUR 2.1 million EIC Accelerator grant. The EIC Accelerator APAC-ON project is focused on early clinical studies of APAC in advanced PAOD/CLI patients in Europe.

Aplagon has two clinical studies ongoing besides the CHASE-study, both sponsored by Aplagon’s long-term partner, Cadila Pharmaceuticals Ltd:

  • The Phase 1 AVF clinical study evaluates the safety and tolerability of three doses of APAC in three 10 patient cohorts of chronic kidney disease patients undergoing vascular surgery to create a radio-cephalic (wrist-area) arteriovenous fistula (AVF) to facilitate hemodialysis. In the study, APAC is administered locally inside the AVF vascular access during the surgical procedure.
  • The Phase 1 safety study is an open label, safety, tolerability and pharmacodynamic, clinical study of single and multiple IVdoses of APAC in 40 healthy subjects.

More than 40 participants have received APAC. There have been no safety concerns to date and the initial clinical findings are encouraging.

Aplagon’s proprietary investigational drug, APAC, a heparin proteoglycan mimetic, is a dual AntiPlatelet and AntiCoagulant (APAC) with unique multifunctional antithrombotic and anti-inflammatory properties. APAC specifically targets arterial injury sites and acts locally at these sites to inhibit thrombosis (blood coagulation or clot formation) and inflammation. Thrombo-inflammation – the dysregulated interaction between blood and vessel wall involving platelets, coagulation processes and inflammation at the vascular injury sites – is a key underlying driver in many vascular diseases, leading to impaired blood circulation and organ damage. APAC is intended for in-hospital use and can be administered either locally (AVF) or by IV infusion (PAOD/CLI).

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About Aplagon Oy (https://aplagon.com)

Aplagon is a clinical stage biopharmaceutical company developing a first-in-class therapeutic APAC for treating thrombo-inflammatory diseases. The company’s first two lead indications are 1) the prevention of AVF maturation failure, to enable life-saving hemodialysis treatment in end-stage kidney disease patients, and 2) CLI, to prevent amputations and other major cardiovascular events in CLI patients. APAC is based on the pioneering research performed by Prof. Riitta Lassila and associates at Wihuri Research Institute in Helsinki, Finland on mast cell-derived heparin proteoglycans.

About the European Innovation Council

The European Innovation Council (EIC) is Europe’s flagship innovation programme to identity, develop and scale up breakthrough technologies and game changing innovations. The EIC has been established under the EU Horizon Europe programme. It has a budget of €10.1 billion to support game changing innovations throughout the lifecycle from early stage research, to proof of concept, technology transfer, and the financing and scale up of start-ups and SMEs. The EIC Accelerator programme supports individual Small and Medium Enterprises (SMEs), in particular startups and spinout companies to develop and scale up game-changing innovations.

For further information, please contact Aki Prihti, CEO (aki.prihti@aplagon.com) or visit www.aplagon.com.