29 March, 2022
aptaTargets announces that is has dosed the first patient in the clinical trial with the drug ApTOLL for treating COVID-19 at the University Hospital La Princesa in Madrid (Spain).
This patient is in Phase 1b of aptaCovid, a randomised, blind, multicentre, placebo-controlled clinical trial that includes 30 patients hospitalised by COVID-19 and are at risk of developing the known cytokine storm syndrome (an excessive and uncontrolled inflammatory process of the illness). The aim of aptaCovid is to evaluate the safety and efficacy of ApTOLL. The study was started at four Spanish hospitals: La Princesa, Ramón y Cajal, Clínico San Carlos of Madrid and the University Hospital of Burgos.
Over three days, the patients will receive three intravenous doses of the drug and their clinical progress, as well as the development of the inflammatory process.
“We will evaluate the safety of ApTOLL in these patients and its potential ability to prevent the evolution of the disease when it is administered alongside the standard authorised treatment that is administered in the country, such as dexamethasone or remdesivir” explains Dr Ignacio Santos, co-principal researcher of the study at La Princesa Hospital.
“There is still a strong need for more therapeutic options to limit the evolution of the disease into advanced inflammatory stages where the prognosis of the patient becomes very severe and can lead to death” highlights Dr Sergio Serrano, co-principal researcher of the study at Ramón y Cajal Hospital.
David Segarra, CEO of aptaTargets, notes: “We are very happy that this aptaCovid trial has included the first patient and that it is taking place at leading hospitals in infectious diseases. ApTOLL offers high potential to be an effective and safe treatment option in patients hospitalised for COVID-19.”
The first results of the study are due for the third quarter of 2022. If they are positive, the company will continue with Phase 2 clinical trials.
AptaCovid was approved by the Spanish Agency of Medicines and Medical Products (AEMPS) at the end of 2021 and has received financing from the Centre for the Development of Industrial Technology (CDTI), an agency of the Spanish Ministry of Science and Innovation.
According to the SEMI-COVID-19 clinical registry, promoted by the Spanish Society of Internal Medicine, 33.8% of patients hospitalised for coronavirus in Spain developed acute respiratory distress syndrome, 10.9% developed bacterial pneumonia and 6.2% developed sepsis. The mortality rate for patients admitted to the ICU was 8.6% (data from Nov 2020).