Treeway announces first patient enrolled in the Phase 2a ASURE clinical trial exploring the safety and effectiveness of oral edaravone to delay disease progression in Alzheimer’s patients

Tilburg, March 6, 2023 – Treeway, in collaboration with the Alzheimer Drug Discovery Foundation (ADDF), announces today the successful enrollment of the first patient in the Alzheimer’s Disease Study Using Oral Edaravone (ASURE), Phase 2a clinical trial.

The trial will include 60 patients in different European countries, and will evaluate the safety, pharmacodynamics and pharmacokinetics of oral edaravone in Alzheimer’s patients. This is the first clinical study that aims to investigate the effect of oral edaravone, a novel multimodal treatment for early onset of Alzheimer’s Disease (AD).

“We are thrilled to venture into a clinical phase for Alzheimer’s Disease, building on our experience in neurodegenerative disease and inspired by patients, our team is passionately working on advancing oral edaravone as a potential treatment for AD,” said Inez de Greef, Chief Executive Officer at Treeway.

AD is a complex disease where multiple disease pathways occur in parallel. Despite recent positive results in the field, there is still a high need to counter AD progression in multiple disease domains. Edaravone is a free radical scavenger and acts by reducing oxidative stress, which plays a pivotal role in the development and progression of the disease. Moreover, edaravone has been shown to modulate mitochondrial dysfunction and pathological neuroimmune processes in AD animal models.

 According to Dr. Everard G.B. Vijverberg, Neurologist and Principal Investigator of the trial: “We are confident that this study will provide us with important information about Alzheimer’s disease as we will be monitoring multiple important pathophysiological mechanisms throughout the study.”

Results from ASURE are expected in early 2025 and the innovative trial design, which includes a panel of biomarkers, novel EEG markers and cognitive functioning outcomes, will investigate the potential of oral edaravone in treating AD.

 Ronald van der Geest, Treeway’s Chief Development Officer added: “We are excited to be enabled by ADDF to extent our activities to Alzheimer’s and to collaborate with one of the top centers in the world. With the help of the Amsterdam team, we believe we have incorporated the latest insights in AD trial design into our study.” 

About Treeway

Treeway is a clinical-stage biotechnology company with a mission to develop therapies for the treatment of amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases, as AD. Founded in 2012 by two ALS patients, Treeway is committed to developing the neurodegenerative disease drugs of tomorrow. Treeway’s research and development portfolio has a strong focus on ALS and AD and is continuously looking to expand the therapeutic targets within the neurodegenerative diseases arena. Treeway’s pipeline has several therapies in development for ALS and has entered the clinical stage with a treatment for AD. Oral edaravone is currently also being tested for the treatment of ALS in a Phase 3 trial in Europe (EUDRACT nr 2020-003376-40). More information available at https://treeway.nl/.   

Treeway, Therapy development inspired by patients.

About Alzheimer’s Disease (AD)

AD is the most common cause of dementia due to the brain changes. These changes are caused by the damage to the nerve cells (neurons) in the brain, which includes the accumulation of abnormal proteins beta-amyloid and phosphorylated tau, as well as the degeneration of neurons, leading to cell death and shrinkage if the brain. Neurons in temporal lobe and hippocampus are the first to suffer damage, regions responsible for storing and retrieving new information. As a result, memory, language, and thinking issues are frequently among the early signs of AD.

About Alzheimer Drug Discovery Foundation (ADDF)

Founded by Leonard A. Lauder and Ronald S. Lauder, ADDF is a nonprofit organization leading the way in Alzheimer’s research since 1998. Their mission is to rapidly accelerate the discovery of drugs to prevent, treat and cure Alzheimer’s disease through several core funding programs or diagnostics accelerator programs. The foundation has awarded more than $209 million to fund over 690 Alzheimer’s drug discovery programs, biomarker programs and clinical trials in 19 countries.

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