Belgian-based biotech Amyl Therapeutics is looking to initiate a Phase I trial with its novel pipeline candidate in patients with amyloidosis, with hopes the candidate could compete with companies such as Eli Lilly and Eisai.

The Phase I trial is due to begin in 2025, with a preclinical study ending in the coming months. The first-in-human study will enrol patients with amyloidosis, which will be a challenge, said Amyl founder and CEO Pierre Vandepapelière.

The biotech is focusing efforts on its unnamed amyloid-targeting candidate in amyloidosis. Amyloidosis is a rare disease which in amyloid builds up in your body, affecting organs such as the heart, kidneys, liver, nervous and digestive systems.

The company said that due to the candidate’s novel mechanism of action, it can also be used for a variety of neurodegenerative diseases (NDDs) including Alzheimer’s disease (AD) and Parkinson’s disease.

The candidate, which is referred to as the ‘Amyl candidate’, is a molecule that conformationally binds to the amyloid fold of toxic protein aggregates such as amyloid-β (Aβ), Tau and α-synuclein that accumulate in the brain.

Amyl Therapeutics’ says that its molecule’s ability to target all amyloid folds offers an advantage over classical monoclonal antibodies.

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By GlobalData

Speaking exclusively to the Clinical Trials Arena, Vandepapelière said that he has been glad to see the results from Lilly’s donanemab and Eisai’s Leqembi (lecanemab) studies as it has confirmed the long-standing hypothesis that amyloid build-up is causative.

“They [Leqembi and dononemab] target one of the amyloid fibrils that are involved in Alzheimer’s disease but only one because those are monoclonal antibodies,” Vandepapelière said.

“There are two, sometimes three different amyloid fibrils that are known to participate in the pathogenesis of Alzheimer’s disease. Our product has the specificity to be able to bind and target and act on all the amyloid fibrils, so we have a competitive advantage.”

Amyl will use $5m in funding gained from a Series A financing round to continue the candidate’s development in amyloidosis. The company is also looking to launch another fundraising round in 2025 to push development in NDDs.

According to a GlobalData report in May 2023, the AD market is expected to reach $13.7b across the eight major markets, which include the US, France, Germany, Italy, Spain, UK, Japan, and China, by 2030.

GlobalData is the parent company of the Clinical Trials Arena.