Muna Therapeutics (Muna), a clinical-stage biotechnology company developing innovative treatments for neurodegenerative diseases, has announced positive results from its phase 1 study of MNA-001, a potent, selective, orally administered small-molecule modulator of triggering receptor expressed on myeloid cells 2 (TREM2) that support the treatment’s potential in early Alzheimer’s disease.
The study demonstrated favourable safety and tolerability, strong cerebrospinal fluid (CSF) exposure, and dose-dependent target engagement in younger and elderly volunteers.
Exploratory analyses of CSF showed that, after repeated dosing of MNA-001, age-associated markers of microglial and innate immune activity and neuronal stress in elderly volunteers shifted toward the levels seen in younger healthy participants. These findings provide evidence of downstream biological activity in humans and support evaluation of MNA-001 in early Alzheimer’s.
Human evidence beyond target engagement MNA-001 was designed to activate TREM2, a critical regulator of microglia, to enhance protective microglial responses to pathology. Microglia maintain brain health by responding to damage, clearing cellular debris and misfolded proteins, and regulating inflammation. Genetic variants that impair TREM2’s activity increase the risk of Alzheimer’s disease.
