The goal of «Spark» is to carry out the first preclinical stage of the development of a first-in-class drug that will prevent, stop and reverse the progression of cognitive impairment associated with schizophrenia and other mental disorders, and to be able to start first-in-humans trials by 2016
The project, which has just won a 500,000 euro endorsement from the Ministry of Economy and Finance through the “Retos-Colaboración” (Challenges-Collaboration) subprogram- will be developed by a consortium led by the biotech Iproteos -located at the Parc Cientific de Barcelona- and comprised by the company Ascil-Biopharm, IRB Barcelona, the Centre for Genomic Regulation and the University of the Basque Country
Currently there is no drug targetting the cognitive impairment associated with schizophrenia, the third most disabling disease even above paraplegia and blindness- according to the WHO and that affects about 24 million people worldwide. It is also the fifth disease with a higher annual cost to society, with more than 35,000 million euros cost only in the Europe Union
A public-private consortium led by the biotech Iproteos –based at Parc Científic de Barcelona (PCB)–, and comprised by the biopharmaceutical company Ascil-Biopharma, the Institute for Biomedical Research (IRB Barcelona), the Centre for Genomic Regulation (CRG) and the University of the Basque Country (UPV/EHU) has launched a project to advance the development of a new neuroprotective drug for the treatment of the cognitive impairment associated with schizophrenia and other mental disorders. The project, called "Spark", has just received a 500,000 euro grant from the Ministry of Economy and Finance, through the 2014 “Retos-Colaboración” (Challenges-Collaboration) subprogram call as part of the National Programme for Research Aimed at the Challenges of Society’ (File. RTC-2014-1645-1).
The drug candidate is IPR019, that belongs to a family of compounds of so-called 'third generation', has been developed and patented by Iproteos. The therapeutic activity of the drug is based on blocking a protein located in the brain that is related to the cognitive impairment. "Our drug acts through a yet unexplored novel mechanism of action in the treatment of schizophrenia, and it is therefore, a first-in-class drug", explains scientist Teresa Tarragó, CEO of Iproteos and researcher at IRB Barcelona.
IPR019 is a peptide derivative (small protein) able to cross the blood-brain barrier- a protective wall of the brain, impassable for most of the drugs available in the market- which has already shown its efficacy as a cognitive enhancer in in vivo tests. Scientists have achieved a significant improvement in learning and memory capabilities, which make it a revolutionary treatment for diseases of the central nervous system in which cognitive abilities are severely diminished.
Iproteos, the biotech coordinating the project, will assess the metabolism and toxicity of candidate compounds and their activity once administered orally and subcutaneously in animal models. The Peptides and Proteins Lab at IRB Barcelona –led by Ernest Giralt where Teresa Tarragó works as associate researcher– will be in charge of the compound synthesis. The Proteomics Unit of the CRG-UPF –led by Eduard Sabidó– will carry out proteomic studies to assess the changes caused in the cells after they are treated with the compounds. ASCIL Biopharm –led by Roland Chérif-Cheikh– will be in charge of the research and development of the oral and infectable pharmaceutical forms. Finally, the Neuropsychopharmacology Unit of the UPV/EHU –led by Javier Meana– will be responsible for ratifyingthe activity of the formulations by means of in vivo studies in animal models of schizophrenia.
The expected end-result will be the obtaining of an optimal formulation and a route of administration of the compound for its use as a drug in patients. This will allow carrying out the regulatory preclinical trials and then the first-in-human trials in 2016 with a future application in health centers.
Schizophrenia is the third most disabling disease- even above paraplegia and blindness- in the DALYS index (Disability-Adjusted Life Years) of the World Health Organization (WHO). It is estimated to affect about 24 million people worldwide, and it is the fifth most costly disease for society in terms of required care and loss of productivity (up to 90% of patients are not working) with an annual cost in the European Union exceeding 35 billion euros.
"The treatment, developed by Iproteos, represents a major advance in the management of this disease. Currently, there are no drugs able to correct the cognitive deficits in patients with schizophrenia, therefore an effective therapy will have a major impact on the life quality of patients. Given its efficacy and innovative nature, there are already multinational pharmaceutical companies interested in following the project progress ", Teresa Tarragó says.