As part of the tender procedure, the company selected a contractor: Łukasiewicz Research Network – Institute of Industrial Organic Chemistry, with whom it will undertake the implementation of the first panel of pre-clinical tests for the aptamer project PB002 (AptaPheresis). The planned research work will include multi-stage in vivo studies in an animal model.
The aim of the first panel study planned by Pure Biologics is to perform pharmacokinetic tests for the model anti-AQP4 antibody.
In the course of the first study, we plan to determine the optimal dose of antibody to be administered to the animals. The half-life of a human recombinant monoclonal antibody (anti-AQP4) dose in the bloodstream of a rabbit will also be established, among other parameters. The next stages of the research will be aimed at getting a lot of information about the mechanism of the proposed extracorporeal therapy and confirming its effectiveness – says Dr. Tomasz Bąkowski, Scientific Project Manager of PB002.
The company decided to establish cooperation with Łukasiewicz Research Network – Institute of Industrial Organic Chemistry, which for over 50 years has been conducting research in the area of toxicology and drug properties. The institute legitimizes itself with quality certificates and authorizations to perform preclinical tests, meeting the high demands placed on subcontractors in terms of experience and technical capabilities.
PB002 is Company’s first and the most developed project in non-systemic therapies based on aptamers, also known as AptaPheresis. Pure Biologics in PB002 develops targeted selective apheresis based on an aptamer biomolecular filter to help patients suffering from periodic exacerbations (relapses) in the rare NMO disease (neuromyelitis optica).
Neuromyelitis Optica (NMO) is a rare neurological autoimmune disease with a paroxysmal, generally severe and progressive course that causes the body to produce pathogenic immunoglobulins (an autoimmune reaction) that cause inflammation of the spinal cord and optic nerves and their subsequent demyelination. Most patients experience disease relapses with periods of remission ranging from weeks to months. Quadriplegia and blindness are not uncommon to develop in a short time. In some patients, unfortunately, this disease as a result of paralysis of the respiratory muscles is fatal. Although NMO disease is classified as a rare disease, it is estimated that around 300,000 people suffer from it all over the world.
The commencement of subsequent panels of preclinical studies in the PB002 project is scheduled for the end of 2021 and the beginning of 2022.