#Taiwan #Alzheimer's Disease #Tainan #Merry Life #TML-6

Merry Life Launches Global Phase II Trial of TML-6

Merry Life Biomedical Company, based in Taiwan, has recently announced the initiation of a global Phase II clinical trial for their innovative oral medication, TML-6. This groundbreaking drug targets the autolysosome pathway, aiming to provide a new avenue for treating Alzheimer's disease (AD), particularly in its early stages.

The Mechanisms Behind TML-6

TML-6 is designed to combat AD through a multi-target strategy, deploying several mechanisms that work synergistically. By activating Nrf2, TML-6 exhibits anti-oxidative properties, which counteract oxidative stress commonly seen in neurodegenerative conditions. Additionally, the drug improves autophagy function by activating autolysosomes, crucial for degrading and clearing harmful substances within neurons and microglia. Moreover, TML-6 helps reduce amyloid plaque accumulation—one of the characteristic markers of AD—by facilitating β-amyloid clearance. The compound also boasts anti-inflammatory effects via the inhibition of NF-κB, further reducing neuronal damage.

Results from Phase I Trials

The promising results from Phase I trials have paved the way for this next stage. In these earlier studies, TML-6 displayed excellent safety and tolerability profiles at dosages ranging from 100 to 200 mg in both healthy participants and elderly adults. These results were crucial for acquiring FDA approval to advance to Phase II trials.

Details of the Phase II Clinical Trial

The upcoming Phase II trial will unfold across 19 sites in the United States, Sweden, and Taiwan, with plans to recruit approximately 210 patients diagnosed with mild cognitive impairment (MCI) or mild dementia. The trial is structured over a 12-month period, focusing on various primary endpoints, which include neuropsychological assessments (such as CDR-SB and iADRS) and relevant blood biomarkers (including levels of p-Tau 217 and Aβ42/40). These evaluations will be supplemented by advanced imaging techniques such as brain MRIs and amyloid PET scans, along with ApoE genotyping for comprehensive patient profiling.

Consultation and Timeline

The design for the Phase II trial has been shaped through a Type C FDA consultation completed on May 13, 2025. The trial is expected to commence in April 2026, orchestrated by Syneos Health as the contract research organization (CRO).

A New Hope for Alzheimer’s Patients

With its robust preclinical and clinical data supporting efficacy and safety, TML-6 shows potential not only as a standalone treatment but also as a complementary option alongside existing anti-amyloid biologics. This innovation is positioned to redefine the therapy landscape for Alzheimer's disease, offering new hope for patients and their families.

About Merry Life Biomedical Company

Merry Life Biomedical is committed to redefining care for patients with neurodegenerative diseases. By harnessing advanced molecular design, pharmacology, and global clinical partnerships, the company aims to address significant unmet medical needs in this field. For further inquiries, please reach Dr. Ih-Jen Su at Merry Life Biomedical Company via phone at +886-910-902-296 or via email.