Aplagon announced that it has closed a €4.8 million financing round, equal to about $5.6 million, to support the expansion of its APAC clinical development program.
The financing will support a new Phase 2 clinical program evaluating APAC for arteriovenous fistula maturation failure in patients with end-stage kidney disease.
The round was led by existing investors Fåhraeus Startup and Growth AB and the European Innovation Council Fund. Finnish investors, including the Jenny and Antti Wihuri Foundation, Innovestor, and the Gösta Serlachius Fine Arts Foundation, also continued their support.
Aplagon is a clinical-stage biotechnology company developing APAC, a first-in-class antiplatelet and anticoagulant therapy designed to treat thrombo-inflammatory diseases.
The company said the financing supports the expansion of its Phase 2 plans in Europe for arteriovenous fistula maturation failure after recently filing its clinical trial application with the European Medicines Agency.
APAC is designed to mimic naturally occurring mast cell-derived heparin proteoglycans. The therapy is intended to localize directly to sites of vascular injury and provide sustained antithrombotic and anti-inflammatory activity where it is needed.
Aplagon said APAC’s dual antithrombotic and anti-inflammatory activity may offer advantages over conventional antithrombotic therapies in vascular diseases driven by both thrombosis and inflammation. More than 70 participants have received APAC to date, with no significant safety concerns observed.
Arteriovenous fistula maturation failure is a major unmet need for patients with end-stage kidney disease who require hemodialysis. About 130,000 new arteriovenous fistulas are created annually in the U.S., but around half fail to mature adequately for long-term dialysis use, often resulting in repeat procedures, hospitalizations, and higher healthcare costs.
Aplagon believes APAC’s localized vascular protective effects could improve arteriovenous fistula maturation outcomes by reducing platelet activation and vascular injury immediately after surgery.
The company also sees broader potential for APAC across vascular interventions where thrombosis and inflammation contribute to poor clinical outcomes.
Aplagon previously announced that the first patient had been dosed in its Phase 2a HEALING clinical trial in peripheral arterial occlusive disease leading to chronic limb-threatening ischemia.
Aplagon’s lead clinical programs focus on the prevention of arteriovenous fistula maturation failure in end-stage kidney disease patients and chronic limb-threatening ischemia. The company said APAC can be administered locally or by IV infusion, creating flexibility across multiple hospital-based clinical settings.
APAC is based on research into mast cell-derived heparin proteoglycans conducted by Prof. Riitta Lassila and associates at the Wihuri Research Institute in Helsinki, Finland.
To date, Aplagon has raised over €20 million through equity financing and non-dilutive funding. The company is headquartered in Helsinki.
KEY QUOTES:
“This financing represents another important milestone for Aplagon as we continue to build momentum around APAC and its potential across a broad range of serious thrombo-inflammatory diseases. The financing supports the expansion of our clinical development plans in Phase 2 in Europe for AVF, having recently filed our CTA with the EMA. The continued backing from our experienced healthcare investors validates both the strength of our clinical progress and the growing recognition of APAC’s differentiated mechanism of action that overcomes the limits of current treatments.”
Aki Prihti, CEO of Aplagon
“Aplagon is addressing a major unmet need in thrombo-inflammatory disease with a highly differentiated therapeutic approach that has the potential to transform outcomes across several vascular indications. Since our initial investment, the company has continued to execute strongly, advancing clinical development while further demonstrating the broad applicability of APAC. We are pleased to continue supporting the team as they move toward important clinical and strategic milestones.”
Johanna Asklin, General Partner at Fåhraeus Startup and Growth
