MNA-001 is a novel potent, selective and orally administered small molecule “triggering receptor expressed on myeloid cells 2” (TREM2) agonist with best-in-class potential for the treatment of early Alzheimer’s and other neurodegenerative diseases, describes the company.

Our goal is to fundamentally shift the focus in Alzheimer’s disease treatment from clearing pathology to bolstering the brain’s innate protective mechanisms.

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“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,” says Rita Balice-Gordon, Ph.D., Muna’s Chief Executive Officer. “This milestone demonstrates our progress toward advancing disease-modifying therapeutics that mitigate key drivers of neurodegeneration and functional impairment to improve disease outcomes.”

We intend for this to be the first of several innovative approaches to enhance the brain’s resilience to pathological drivers of neurodegeneration.

The primary objective of Muna’s Phase 1 randomized, double-blind, placebo-controlled study is to evaluate the safety and tolerability of MNA-001 in healthy adult and elderly subjects. The study will also assess pharmacokinetics and the pharmacodynamic effects of MNA-001 on biomarkers of TREM2 engagement and activation in plasma and CSF. It also will leverage Muna’s novel biomarker discoveries to provide early insights into MNA-001’s activity in humans, with topline data expected in late summer, 2026.

“We believe that MNA-001 has the potential to treat disease and improve quality of life for Alzheimer’s patients and their loved ones,” says Donald Nicholson, Chair of Muna’s Board of Directors. “We intend for this to be the first of several innovative approaches to enhance the brain’s resilience to pathological drivers of neurodegeneration.”