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ISC 2023 | APRIL trial: ApTOLL demonstrates neuroprotective effects in acute ischemic stroke

Marc Ribo, MD, PhD, Vall d’Hebron University Hospital, Barcelona, Spain, shares an overview of the Phase Ib/IIa APRIL trial (NCT04734548) which investigated the safety and efficacy of ApTOLL, an aptamer targeted against Toll-like receptor 4 (TLR4), for the treatment of acute ischemic stroke. TLR4 is a key receptor in the regulation of immune responses which when activated, leads to the production of pro-inflammatory cytokines. Preclinical studies found ApTOLL to have long-lasting protective effects against experimental cerebral ischemia in rodent models. A first-in-human study identified no serious adverse events and demonstrated a favorable pharmacokinetic profile. These promising findings led to the double-blind, randomized, placebo-controlled APRIL study. The two best doses to be taken forward were established in the Phase Ib portion, after which 120 patients were randomized to receive low dose ApTOLL, high dose ApTOLL, or placebo, prior to endovascular treatment. Primary endpoint analysis demonstrated a significant reduction in mortality at 90 days with high dose ApTOLL compared to placebo (4.76% vs 16.98%). Additionally, mean infarct volume at 72 hours and disability at 90 days were significantly reduced in the high dose ApTOLL cohort, compared to placebo. Trends towards reduced brain edema and hemorrhagic transformation were also noted with ApTOLL use. These results highlight the potential neuroprotective capabilities of ApTOLL in ischemic stroke. This interview took place during the International Stroke Conference (ISC) 2023 in Dallas, TX.

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MR is a consultant for Apta Targets.