Muscarinic agonists have emerged as a new class of therapeutic agents for the

treatment of psychosis with a mechanism distinct from typical and atypical

antipsychotics. M₁ and M₄ receptor subtypes show the highest expression in brain

regions implicated in psychosis, cognition, and negative symptoms, and thus have

therapeutic potential across several neuropsychiatric disorders including

Alzheimer’s disease psychosis and schizophrenia. ML-007C-MA is an

investigational fixed-dose combination of a novel M₁/M₄ muscarinic agonist, ML-

007 and fesoterodine fumarate, a peripherally-acting muscarinic antagonist.

Fesoterodine is ideally suited for the combination due to its low brain penetration,

predictable pharmacokinetics, and favorable physicochemical properties that

enabled precision matching of the exposure profiles. By synchronizing the

pharmacokinetic exposures of agonist and antagonist components in the

periphery, ML-007C-MA was designed to maintain strong activation of M₁ and M₄

receptors in the brain to drive efficacy while mitigating cholinergic side effects that

can result from modulation of muscarinic receptors in the periphery.