Taiwan-based Merry Life Biomedical Company announced on Thursday the launch of its global Phase II clinical trial for TML-6, a novel oral small molecule drug targeting early-stage Alzheimer's disease (AD).

TML-6 combines multiple mechanisms, including anti-oxidative effects (Nrf2 activation), melioration of autophagy function (autolysosomal activation), anti-amyloid accumulation (beta-amyloid clearance), and anti-inflammatory effects (through NF-kB inhibition) through autolysosome pathway in neurons and microglia to remove intraneuronal and extracellular amyloid accumulation, representing the first in human multi-target strategy for AD treatment.

Merry Life said that the Phase I trial demonstrated excellent safety, tolerability, and pharmacokinetics at 100–200 mg in both healthy and elderly adults. TML-6 will now advance to a Phase II trial at 19 sites across the United States, Sweden, and Taiwan after FDA approval. This 12-month study will enrol 210 patients with mild cognitive impairment (MCI) or mild dementia.

Primary endpoints will include neuropsychological assessments (CDR-SB, iADRS) and blood biomarkers (p-Tau 217, A beta 42/40, NfL, GFAP), supported by brain MRI, amyloid PET scans, and ApoE genotyping. Type C FDA consultation for phase 2 trial design was completed on 13 May 2025, with trial initiation expected in April 2026, conducted by Syneos Health CRO.