Merry Life Biomedical Advances Global Phase II Trial of TML-6 for Early Alzheimer’s Disease
Taiwan’s Merry Life Biomedical has advanced its locally-developed oral drug candidate TML-6 into a global Phase II clinical trial for early Alzheimer’s disease, according to a company press release. The multinational study spans Taiwan, Sweden, and the United States and brings together 20 clinical sites, including nine medical centers in Taiwan, seven sites in Sweden, and four centers in the U.S. Approximately 210 patients with early Alzheimer’s disease are expected to participate in the trial.
The randomized, double-blind, placebo-controlled study will evaluate TML-6 at two dose levels, with participants receiving either 100 mg or 200 mg of the drug, or placebo, once daily for 52 weeks. The primary endpoint is the change from baseline in the Clinical Dementia Rating Sum of Boxes (CDR-SB), which measures cognitive and functional changes associated with dementia. Secondary endpoints include blood biomarkers such as phosphorylated tau 217 (p-Tau 217), amyloid-beta (Aβ), glial fibrillary acidic protein (GFAP), and neurofilament light chain (NfL), providing additional measures of disease-related pathology and neurodegeneration.
TML-6 is being developed around a potentially complementary approach to Alzheimer’s disease treatment. While existing disease-modifying therapies have focused primarily on removing amyloid plaques from the brain, TML-6 is being investigated for its effects on the autophagy-lysosomal pathway, a cellular system responsible for clearing and recycling damaged proteins and other cellular components. Merry Life Biomedical said research on TML-6 has increasingly focused on this pathway and its potential role in maintaining neuronal and microglial function, as well as addressing mechanisms associated with amyloid-related pathology, oxidative stress, and inflammation.
The global study also brings together international expertise in Alzheimer’s clinical research, biomarkers, and brain imaging. Seven Swedish clinical sites are participating in the program in collaboration with researchers affiliated with the Karolinska Institute and Karolinska University Hospital.
Taiwan represents the largest group of participating sites in the study, with nine medical centers taking part alongside the Swedish and U.S. sites. Merry Life Biomedical views the international Phase II program as an opportunity to advance a drug candidate developed in Taiwan through a globally coordinated clinical development program and to establish broader international clinical and research networks.
With TML-6 now entering Phase II, with results expected to help guide the company’s subsequent development strategy, including potential advancement into Phase III and broader international development. Merry Life Biomedical is also exploring potential strategic investment, venture capital, capital-market financing, and partnerships with global pharmaceutical companies to support the next stages of TML-6 development.