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.”
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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:
|At the Company:
Aki Prihti, CEO
Tel. +358-40-762 5159
Melanie Toyne-Sewell / Katie Duffell
Tel: +44 20 7457 2013