ApTOLL: An innovative neuroprotectant to reduce brain damage in Acute Ischemic Stroke (AIS)

Project Information

ApTOLL

Grant agreement ID: 101163492

DOI

10.3030/101163492

Project closed

EC signature date 20 May 2024

Start date 1 January 2024

End date 31 March 2026

Funded under

• The European Innovation Council (EIC)

Total cost

€ 3 569 737,25

EU contribution

€ 2 498 816,00

Coordinated by

APTATARGETS SL
Spain

Periodic Reporting for period 1 - ApTOLL (ApTOLL: An innovative neuroprotectant to reduce brain damage in Acute Ischemic Stroke (AIS))

Reporting period: 2024-01-01 to 2025-02-28

Summary of the context and overall objectives of the project

Stroke is a devastating medical condition affecting 15 million people worldwide yearly, being Ischemic Stroke the most frequent (87%). Indeed, the global cost of stroke is >€847b (≈€60b in EU) due to the huge socioeconomic burden of disabilities. Reperfusion treatment improves outcomes, but only ≈20% of patients are currently eligible for treatment due to the narrow therapeutic window after stroke symptom onset and stringent selection criteria for eligibility. Novel therapies - small molecules or biologics - targeting neuroprotection have not achieved enough efficacy to get approved.

To face this challenge, AptaTargets has developed ApTOLL, which is an innovative neuroprotectant aimed at reducing brain damage in Acute Ischemic Stroke (AIS) when used in combination with endovascular therapy (EVT).

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

During the first half of the apTOLL project´s implementation, AptaTargets has advanced in the following activities:
• the design and preparations of late-stage clinical trials in acute ischemic stroke patients,
• optimization of the manufacturing process and
• development of non-clinical studies to expedite the access to the markets.

Regarding exploitation activities, AptaTargets has achieved a major objective, signing a transaction with a big pharma.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Following the successful preclinical development and a Phase I First-in-Human trial, AptaTargets conducted a Phase II clinical trial in AIS patients with outstanding results, showing that ApTOLL is able to reduce the brain damage and significantly improve functional outcomes.

In addition, AptaTargets has advanced in its ApTOLL-AIS program and has recently partnered with a global pharmaceutical company that will take the product to the market and launch clinical trials in other indications.

AptaTargets team at International Stroke Conference 2025, Los Angeles (USA).