It blocks the mechanisms that cause the death of neurons.
A new neuroprotective drug has demonstrated safety and efficacy in reducing lesions in ischemic stroke patients. The drug ApTOLL blocks the mechanisms that cause neurons to die until the patient receives treatment to restore blood flow. It acts as an antagonist on the TLR4 receptor, a molecule that is involved in all the inflammatory mechanisms that trigger stroke and cause cell death and damage.
In the phase 1b/2a clinical trial led by the Vall d’Hebron hospital in Barcelona, with the participation of 13 other Spanish and French centers and 151 stroke patients, the drug has shown safety and efficacy. The group that received a high dose had an 18% decrease in mortality compared to 5% in the group treated with placebo. In addition, this dose reduced end-infarct volume and improved US State Stroke Scale scores at 72 hours. 64% of the high-dose patients had functional independence at 90 days, compared with 46.3% of those treated with placebo.
“This is the first time that a medication has shown a neuroprotective effect in patients with a stroke,” explains neurologist Marc Ribó, principal investigator in stroke at Vall d’Hebron and medical director of aptaTargets, the company that developed the drug. Ribó has presented the results of the clinical study in the main plenary session of the International Conference on Cardiovascular Accidents held in Dallas (USA).
A study will begin in April in different areas of Catalonia to verify the results in a prehospital administration: EMS professionals will inject the drug in the ambulance to see its effect until arrival at the hospital and in the hours afterward. The slogan in stroke is to gain time.
On the other hand, in the fourth quarter of this year a pivotal study will begin that will last approximately one year. “If we confirm the results obtained so far in terms of safety and efficacy, the (public drug) agencies should approve it as routine treatment for all patients, and this could happen in a couple of years,” Ribó projects. In recent decades, she explains, “tens or hundreds” of drugs have been tried to try to protect the brain during times of ischemia (lack of blood flow). Antonio Lopez Tovar