Muna Therapeutics has dosed the first participants in a Phase I trial of its lead asset MNA-001 to treat early Alzheimer’s disease.
The single-ascending/multiple-ascending dose study will assess the therapy in healthy adult individuals.
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MNA-001 is an orally administered small molecule that acts as a selective and potent agonist of the triggering receptor expressed on myeloid cells 2 (TREM2). It is intended for Alzheimer’s and other neurodegenerative disorders.
The Phase I placebo-controlled, randomised, double-blind study aims to assess its tolerability and safety in elderly participants and healthy adults.
It will also evaluate pharmacodynamic and pharmacokinetics effects on biomarkers of TREM2 engagement in plasma and cerebrospinal fluid.
The study will utilise new biomarker findings to offer early insights into human activities, with topline results anticipated by the end of mid-2026.
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By GlobalDataMuna CEO Rita Balice-Gordon said: “We are delighted to have initiated clinical development of MNA-001. Our goal is to fundamentally shift the focus in Alzheimer’s disease treatment from clearing pathology to bolstering the brain’s innate protective mechanisms.
“This milestone demonstrates our progress toward advancing disease-modifying therapeutics that mitigate key drivers of neurodegeneration and functional impairment to improve disease outcomes.”
MNA-001 activates TREM2, a key regulator of microglia brain cells with immune and other functions.
By enhancing TREM2 signalling, the therapy promotes protective microglial responses that aid the phagocytosis of toxic misfolded proteins and cell debris, potentially slowing neurodegeneration.
Preclinical data showed a considerable decrease in amyloid pathology and reprogramming of disease-related microglia to protective states in animal models of Alzheimer’s.
The molecule was found to be well tolerated and safe in preclinical toxicology assessments.
