A new neuroprotective drug shows good preliminary results for ischemic stroke

  • According to the results of the APRIL study, in which the Hospital de Bellvitge and IDIBELL have participated, ApTOLL has shown good safety in 151 patients with acute ischemic stroke.
  • The paper also highlights that preliminary efficacy results show that the drug significantly reduces mortality and long-term functional disability.

The prestigious scientific journal JAMA Neurology has published positive results from a clinical trial called APRIL, which has evaluated the effect of an innovative neuroprotective drug called ApTOLL in combination with endovascular treatment in patients with acute ischemic stroke.

The study has shown that administration of ApTOLL within 6 hours of stroke, together with endovascular treatment, is safe and well tolerated. In addition, patients who received ApTOLL showed a significant reduction in mortality (from 18% to 5%) and improved function at 90 days compared to patients who received placebo.

Dr. Pere Cardona, director of the Stroke Unit at Bellvitge University Hospital (HUB) and principal investigator of IDIBELL’s Neurological and Neurogenetic Diseases group, highlighted the importance of these results: “ApTOLL is the first neuroprotective drug that has shown great efficacy and safety in the acute phase of severe stroke. This makes it a promising candidate for future studies in hospital and prehospital settings.”

The APRIL study was carried out in 14 stroke reference centers in Spain and France and included 151 patients who were randomized to receive ApTOLL or a placebo before thrombectomy, with the main endpoint being safety determined by death, symptomatic intracranial hemorrhage, and malignant and recurrent cerebrovascular accidents. The volume of the infarct and the severity of the symptoms at 72 hours and the disability at 90 days were also evaluated.

Stroke is a serious disease that will affect 1 in 4 adults over the age of 25 throughout their lives, and acute ischemic stroke is the most common form. Despite reperfusion treatments, many patients continue to develop significant disabilities. Therefore, ApTOLL emerges as a promising hope as a neuroprotective drug to improve stroke outcomes in combination with other treatments. In addition, it is important to note that ApTOLL already has priority drug designation from the European Medicines Agency (EMA), recognizing its potential importance in the medical field.


Original paper:

Safety and Efficacy of ApTOLL in Patients with Ischemic Stroke Undergoing Endovascular Treatment. Hernández-Jiménez M, Abad-Santos F, Cotgreave I, Gallego J, Jilma B, Flores A, Govin T, Vivancos J, Hernández-Pérez M, Molina C, Montaner J, Casariego J, Dalsgaard M, Liebeskind D, Cobo E, Castellanos M, Cardona Portela P, Masjuán J, Moniche F, Tembl J, Terceño Izaga M, Arenillas J, Callejas P, Olivot J, Calviere L, Henon H, Mazighi M, Piñeiro D, Pugliese M, González V, Moro M, Garcia-Tornel A, Lizasoain I, Ribó M. JAMA Neurology, 2023.

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