Merry Life Biomedical Company has announced the launch of its global Phase II clinical trial for TML-6, a novel oral small molecule drug targeting early-stage Alzheimer's disease. The Taiwan-based biotechnology company positions TML-6 as the first drug to target the autolysosome pathway for Alzheimer's treatment, representing a pioneering multi-target therapeutic approach.
Novel Multi-Target Mechanism
TML-6 combines multiple therapeutic mechanisms through the autolysosome pathway in neurons and microglia. The drug's comprehensive approach includes anti-oxidative effects through Nrf2 activation, improvement of autophagy function via autolysosomal activation, anti-amyloid accumulation through β-amyloid clearance, and anti-inflammatory effects through NF-κB inhibition. This multi-target strategy aims to remove both intraneuronal and extracellular amyloid accumulation, marking the first in human application of such an approach for Alzheimer's disease treatment.
Phase I Results Support Advancement
The Phase I trial demonstrated excellent safety, tolerability, and pharmacokinetics at doses of 100-200 mg in both healthy and elderly adults. These positive results provided the foundation for FDA approval to proceed to Phase II testing, with the company completing Type C FDA consultation for phase 2 trial design on May 13, 2025.
Global Phase II Trial Design
The upcoming Phase II study represents a comprehensive 12-month trial that will enroll 210 patients with mild cognitive impairment (MCI) or mild dementia. The trial will be conducted across 19 sites spanning three regions: the United States, Sweden, and Taiwan. Syneos Health CRO will conduct the study, with trial initiation expected in April 2026.
Primary endpoints will include neuropsychological assessments using CDR-SB (Clinical Dementia Rating-Sum of Boxes) and iADRS (integrated Alzheimer's Disease Rating Scale). The study will also evaluate blood biomarkers including p-Tau 217, Aβ42/40, NfL (neurofilament light chain), and GFAP (glial fibrillary acidic protein). Supporting assessments will include brain MRI, amyloid PET scans, and ApoE genotyping to provide comprehensive evaluation of the drug's efficacy.
Therapeutic Potential and Future Applications
With its strong preclinical and clinical profile, TML-6 holds promise as both a monotherapy and in combination with anti-amyloid biologics. This flexibility in treatment approaches could provide new therapeutic options for patients with Alzheimer's disease, addressing the urgent unmet medical needs in neurodegenerative disease treatment.
Merry Life Biomedical focuses on developing innovative therapies for neurodegenerative and age-related diseases, leveraging advanced molecular design, pharmacological innovation, formulation optimization, and global clinical development capabilities.
