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.
ApTOLL is an innovative drug based on aptamer technology, with immunomodulator and anti-inflammatory effect, developed by the biopharmaceutical aptaTargets.
The study will evaluate the safety and efficacy of ApTOLL in 30 patients with COVID-19 at four Spanish hospitals.
Madrid (Spain), 28 March 2022 – aptaTargets, a biopharmaceutical company specialising in the development of innovative therapies based on aptamer technology, announces that it 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).
27580. ApTOLL
ApTOLL is a novel single-stranded DNA molecule (aptamer) with immunomodulator and anti-inflammatory effect. Its activity focuses on blocking the activation of TLR4, a receptor located on the surface of immune cells responsible for initiating the inflammatory cascade. Upon blocking this activation, ApTOLL modulates the inflammatory response, and therefore, it prevents the development of the cytokine storm syndrome in the most severe COVID-19 cases.
ApTOLL has shown efficacy in preclinical studies for ischaemic stroke, haemorrhagic stroke, myocardial infarction and multiple sclerosis, and an excellent safety profile in Phase I and Phase Ib clinical trials on healthy volunteers and patients with ischaemic stroke. Currently, ApTOLL is moving forward in a Phase 2a clinical trial where its efficacy in patients with acute ischaemic stroke will be studied.
- aptaTargets
aptaTargets is a clinical stage biopharmaceutical company specialising in the development of therapeutic applications based on aptamer technology. Its main drug is ApTOLL, a molecule with immunomodulator and anti-inflammatory effect that is being researched for acute ischaemic stroke (Phase 2a), COVID-19 (Phase 1b) and intracerebral haemorrhage, myocardial infarction and multiple sclerosis (preclinical). Founded in 2014, aptaTargets’ headquarters are located in Madrid and has secured 5 million euros in investment led by Inveready and the CDTI (Spanish Ministry of Science and Innovation) through the Innvierte programme. More information: aptatargets.com
Media contact:
Gemma Escarré Comms
aptatargets@gemmaescarre.com
M +34 667 76 15 24
www.aptatargets.com