1 March, 2023
aptaTargets has obtained priority medicines (PRIME) designation from the European Medicines Agency (EMA) for the neuroprotectant ApTOLL to improve the treatment of acute ischemic stroke, which accounts for 85% of strokes.
The designation is based on positive safety and efficacy data from the APRIL Phase 1b/2a clinical trial. These results were recently presented at the International Stroke Conference (ISC) 2023.
PRIME status is granted to drug candidates that may offer a significant therapeutic advantage over existing treatments or benefit patients without treatment options. In 2022, only six medicines obtained PRIME designation.
ApTOLL is a first-in-class neuroprotective drug that acts on the Toll-like receptor 4 (TLR4) with high specificity by blocking the inflammatory response following ischemic stroke. Dr Marc Ribó, Chief Medical Officer of aptaTargets and interventional neurologist of the Vall d’Hebron University Hospital of Barcelona, and Dr Macarena Hernández, Chief Scientific Officer of aptaTargets, presented at the ISC the clinical advances demonstrated by ApTOLL, from reducing patient mortality from 18% to 5% to significantly reducing long-term functional disability. The company plans to start Phase 2b/3 clinical trials this year.
“We are very pleased to receive PRIME designation for ApTOLL as it is a very important step that will help us to receive scientific support by the EMA and expedite its market authorisation in Europe if the results of the upcoming Phase 2b/3 clinical trial are positive,” explains David Segarra, CEO of aptaTargets.
“Receiving PRIME designation is a strong advancement towards getting ApTOLL to ischemic stroke patients as rapidly as possible, both for patients who receive mechanical thrombectomy as studied in the APRIL trial and then the remainder of people who experience an ischemic stroke”, commented David Saxner, Business Development Director of aptaTargets.
Administration of ApTOLL will also soon be studied in ambulances when the Emergency Medical System (EMS) detects that the patient may suffer an ischemic stroke (Phase 2a) and in myocardial infarction (Phase 2a). In other pathologies, such as intracerebral haemorrhage and multiple sclerosis, it has shown promising preclinical results.