HELSINKI, November 16, 2022. Aplagon Oy (Aplagon), the Finnish pharmaceutical development company developing first-in-class vasculoprotective antithrombotic agents (APACs) to treat vascular injury related blood vessel occlusions and tissue damage, today announced that it had signed an EIC Accelerator grant agreement (Grant Agreement) with the European Innovation Council and SMEs Executive Agency (EISMEA).

Under the Grant Agreement, Aplagon will receive up to EUR 2.1 million grant funding, representing 70% of the total project costs, for the execution of its EIC Accelerator APAC-ON project. APAC-ON focuses on early clinical studies of Aplagon’s lead pharmaceutical agent, APAC, in advanced peripheral arterial occlusive disease / critical limb ischemia (PAOD/CLI) patients in Europe. In addition, under the EIC Accelerator blended finance programme, Aplagon is eligible to receive up to EUR 7.0 million in direct equity investments from the EIC Fund.

Aki Prihti, CEO of Aplagon, said: “We are highly excited about the EIC Accelerator funding and grateful for the European Innovation Council for enabling our development program in advanced PAOD/CLI patients. There is a major unmet need for new effective and safe therapies in this indication, and APAC has the potential to provide a new therapy option for these patients.”

More than 200 million patients suffer from PAOD, which is a serious chronic cardiovascular condition caused by inflammation, atherosclerosis and thrombosis (blood clot formation), leading to an impaired and eventually full occlusion of blood flow to the lower limbs. An estimated 30 million patients worldwide and 6-7 million patients in the US and Europe suffer from CLI, the most advanced stage of PAOD, causing pain, ulcers and tissue death. CLI is associated with a high risk of leg amputation and other cardiovascular diseases in heart, brain and kidneys, increasing the risk of death. There is a major unmet need for new effective and safe therapies as current treatments and interventions are only partially efficacious.

APAC, a mimetic of the body’s own heparin proteoglycans, provides potentially a new way of treating advanced PAOD/CLI patients. APAC addresses the underlying causes of the disease by uniquely targeting the vascular injury (atherosclerotic) sites, sealing the vascular surface, cooling down the processes of blood clotting (platelets, coagulation) and thromboinflammation and inhibiting the progression of atherosclerosis. APAC’s localised action also potentially reduces the risk for bleeding complications compared with antithrombotic drugs that predominantly rely on systemic effects. APAC is expected to be applicable in hospital use both in connection with the revascularization procedures of the affected arteries and microcirculation, and as a maintenance therapy by intravenous infusions.

– Ends –

About Aplagon Oy
Aplagon Oy is a pharmaceutical development company, based in Helsinki, Finland, developing proprietary locally acting vasculoprotective antithrombotic products (APACs) for the management of vascular injury related blood vessel occlusions and tissue damage. Aplagon 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. In the first year of the EIC Accelerator programme, out of more than 4000 applicants, 164 projects have been selected for funding.

The EIC Fund is owned by the European Commission and established to make direct equity investments in breakthrough innovation companies selected for EIC Accelerator blended finance support (grant and equity).
For further information, please contact Aki Prihti, CEO (aki.prihti@aplagon.com) or visit www.aplagon.com.

HELSINKI, June 7, 2022. Aplagon Oy (“Aplagon”), the Finnish pharmaceutical development company developing first-in-class vasculoprotective antithrombotic agents to treat vascular injury related blood vessel occlusions and tissue damage, today announced that its lead pharmaceutical agent, APAC, has been administered for the first time in a clinical study.

The Phase 1 clinical study is primarily intended to evaluate the safety of APAC in 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 into the AVF during the hemodialysis vascular access surgery. The study is sponsored by Aplagon’s long-term partner, Cadila Pharmaceuticals Ltd., and is expected to enroll 30 patients.

Patients with end-stage renal disease (kidney failure) require hemodialysis, a life-saving treatment that cannot be conducted without functioning vascular access. Lack of early AVF maturation precludes the initiation of dialysis programs. Moreover, vascular access failure or dysfunction is a leading cause of hospitalisation and morbidity, representing a major unmet need in dialysis patients. More than 50% of AVFs occlude or require corrective procedures within the first year.

Aplagon’s APAC is a first-in-class antithrombotic agent with protective effects to manage vascular injury-related occlusions and tissue damage. The agent is named after its unique dual antiplatelet (AP) and anticoagulant (AC) activity. APAC actively targets vascular injury sites to provide long-term local antithrombotic and anti-inflammatory protection without a prolonged systemic effect. As a result, the bleeding risk with APAC is anticipated to be less than with traditional systemic antithrombotics. The initial target indications for APAC include hemodialysis access failure, COVID-19/sepsis-induced coagulopathy, and peripheral arterial occlusive disease.

Riitta Lassila, Chief Scientific Officer of Aplagon and inventor of APAC, said: “The safe administration of APAC to the first patient in a clinical trial is a major milestone for Aplagon. We hope that APAC will provide a novel management tool benefitting dialysis patients.”

Aki Prihti, CEO of Aplagon, said: “After years of hard work, we are extremely pleased to have successfully transitioned to become a clinical-phase company. This first clinical study with our partner Cadila Pharmaceuticals will provide the basis for future clinical development of APAC worldwide.”

– Ends –

About Aplagon Oy (www.aplagon.com)
Aplagon Oy is a pharmaceutical development company, based in Helsinki, Finland, developing proprietary locally acting vasculoprotective antithrombotic products (APACs) for the management of vascular injury related blood vessel occlusions and tissue damage.

Aplagon has a strong network of collaborators among top scientists and laboratories in Europe and the US in the field of vascular medicine and is backed by leading Finnish life science investors. Aplagon is partnered with Cadila Pharmaceuticals Ltd, one of the largest privately owned pharmaceutical companies in India, for the clinical development and commercialisation of APAC in India.

Aplagon was founded in 2009 and 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. Aplagon owns all Intellectual Property rights to the APAC molecules.

For further information, please contact:

HELSINKI, May 28, 2021. Aplagon Oy (“Aplagon”), the Finnish pharmaceutical development company developing first-in-class vasculoprotective antithrombotic compounds to treat vascular injury related blood vessel occlusions and tissue damage, today announced the closing of a EUR 2.2 million funding round. The fundraise was arranged in collaboration with Invesdor Group and was oversubscribed.

These funds increase the total equity investments and Business Finland R&D-loans so far raised by Aplagon to EUR 11.5 million. The majority of the raise will be used to fund planned clinical studies, including a Phase 1/2a study in end-stage chronic kidney disease patients undergoing vascular access surgery for dialysis, a Phase 1 study in healthy volunteers, and a Phase 2 study in patients suffering from COVID-19-induced coagulopathy. The studies will be performed in India in collaboration with Aplagon’s local partner, Cadila Pharmaceuticals Ltd.

Aki Prihti, CEO of Aplagon, said: “We are extremely pleased with the successful closing of the funding round and the strong interest shown by investors. The funds raised will enable us to move forward with planned clinical studies of our APAC therapeutics with the goal of demonstrating their preliminary safety and efficacy in our initial target indications. We would like to thank our existing investors for their continued support and welcome our new investors as shareholders in Aplagon”.

Aplagon’s APACs are first-in-class antithrombotic compounds with-vasculoprotective effects, for the management of vascular injury related blood vessel occlusions and tissue damage. The compounds are named after their unique dual antiplatelet (AP) and anticoagulant (AC) activity. They actively target vascular injury sites where they provide local long-term antithrombotic and anti-inflammatory protection without a prolonged systemic effect, thereby also reducing the bleeding risks associated with systemic antithrombotics. The initial target indications for APACs include hemodialysis access failure, COVID-19/sepsis-induced coagulopathy, and peripheral arterial disease.

– Ends –

About Aplagon Oy (www.aplagon.com)
Aplagon Oy is a pharmaceutical discovery and development company, based in Helsinki, Finland, developing proprietary locally acting vasculoprotective antithrombotic products (APACs) for the management of vascular injury related blood vessel occlusions and tissue damage.

Aplagon has a strong network of collaborators among top scientists and laboratories in Europe and the US in the field of vascular medicine and is backed by leading Finnish life science investors. Aplagon is partnered with Cadila Pharmaceuticals Ltd, one of the largest privately owned pharmaceutical companies in India, for the clinical development and commercialisation of APAC in India.

Aplagon was founded in 2009 and 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. Aplagon owns all Intellectual Property rights to the APAC molecule.

For further information, please contact: