Oscotec and ADEL have dosed the first healthy subject in a Phase Ia/Ib study of ADEL-Y01, a treatment aimed at addressing Alzheimer’s disease (AD) by targeting tau protein accumulation in the brain.

The companies are collaborating on the development of ADEL-Y01, a disease-modifying immunotherapy agent designed to inhibit the aggregation and propagation of toxic tau proteins.

The acetylated tau protein at lysine-280 (acK280) is the specific target of ADEL-Y01, which could potentially decelerate AD progression.

This trial in the US aims to assess the tolerability, safety, pharmacokinetics and clinical activity of ADEL-Y01.

It will enrol 40 healthy subjects and 33 subjects with mild cognitive impairment due to AD or mild AD.

Preclinical data of ADEL-Y01 have shown promising outcomes in animal models.

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The study demonstrated that treatment with the immunotherapy offered improvements in memory impairment and behavioural deficits by hindering Tau seeding and propagation.

ADEL CEO SeungYong Yoon said: “Given that tau is strongly correlated with AD progression and clinical severity, targeting of tau is anticipated to effectively slow the disease progress. As our understanding of the pivotal role of the tau mid-region MTBR increases, selecting the right epitope becomes crucial in developing tau-targeting therapeutics to attain clinical benefits.”

Oscotec focuses on developing innovative therapies for unmet clinical needs. Its clinical pipeline comprises targeted therapeutics in the fields of immunology and oncology.

The company is also advancing cevidoplenib, a SYK inhibitor for immune thrombocytopenia (ITP) and has completed a Phase II trial.

Another Phase I asset, a FLT3/AXL inhibitor is developed for acute myeloid leukaemia (AML), as well as solid tumours.

Oscotec CEO Taeyoung Yoon said: “Oscotec is pleased to reach a significant milestone leading the clinical study as a co-developer with ADEL, and we will continue to bring innovative medicines in neurogenerative diseases.”