30 November, 2021
aptaTargets begins the APTACOVID trial, in which hospitalized patients susceptible to develop an uncontrolled inflammatory process will be treated with ApTOLL.
The Spanish Agency for Medicines and Health Products, AEMPS, has authorized the biotechnology company aptaTargets to start the APTACOVID study, a Phase Ib clinical trial in 30 patients hospitalized for COVID-19 susceptible to develop an uncontrolled inflammatory process that, potentially, can lead to the ICU and even death. This first trial in COVID-19 patients will be carried out at the Ramón y Cajal Hospital and at the La Princesa Hospital, both in Madrid.
ApTOLL is the only drug in development for the treatment of ischemic stroke that blocks the activation of TLR4, a receptor located in the immune cells surface, such as microglia, neutrophils, macrophages, and lymphocytes.
The activation of TLR4 initiates the inflammatory cascade and, therefore, by blocking this activation, ApTOLL modulates the inflammatory response that causes tissue damage, thereby preventing the development of the much-feared cytokine storm syndrome that occurs in the most severe cases of COVID-19. Administered to COVID-19 patients suffering from uncontrolled and exacerbated inflammatory response, ApTOLL could generate an important benefit by reducing the associated damage and avoiding the fatal consequences that the cytokine storm syndrome causes (multiple organ failure and death, in the most serious cases). Therefore, ApTOLL could reduce the saturation of Intensive Care Units and of health systems worldwide.
Despite the global impact of the pandemic, and the impact of vaccines on the development of the disease, the therapeutic options to treat COVID-19 are very limited and, practically, focused on the repositioning of drugs, as is the case of dexamethasone. However, the development of drugs to prevent and treat cytokine storm syndrome is still a priority, thus avoiding the evolution of the disease to serious stages, as well as the development of complications such as, for example, the formation of clots that can cause tissue damage due to ischemic processes secondarily to SARS-Cov-2 infection. Controlling, first, the inflammatory process in COVID-19 patients and, secondly, the subsequent damage to vital organs, provides the opportunity of improving patient´s outcomes and reduces the possibility of developing fatal complications such as multiorgan failure and death.
Founded in 2014 by David Segarra and Maria Eugenia Zarabozo, aptaTargets span-out from Aptus Biotech, an aptamer technology platform. AptaTargets started a drug development program, in collaboration with the Complutense University and the Ramón y Cajal University Hospital. In October 2020, aptaTargets started APRIL, a Phase Ib / IIa clinical trial testing ApTOLL, a novel and powerful immunomodulator and anti-inflammatory, capable of reducing brain damage in stroke. ApTOLL is the first aptamer (single-stranded DNA molecule) targeting TLR4, a receptor that triggers the immune response in the first steps of the inflammatory pathway against stroke, and also in other pathologies.
Also in 2020, aptaTargets closed a round of financing, with the participation of Inveready and CDTI, through its INNVIERTE program, which has mobilised up to 5 million euros to be invested between 2020 and 2022.
Funded by the CDTI
The APTACOVID clinical study is included in the project “NeumoToll-ApTOLL and its effects for the treatment of respiratory problems caused by SARS-COV-2”, financed with the help of the CDTI, from the Ministry of Science and Innovation, through of its PID (Research and Development Projects) program.