Taipei – September 21, 2026 -- Merry Life Biomedical has advanced TML-6, a Taiwan-developed oral therapy for early Alzheimer's disease, into a global Phase 2 trial spanning 20 clinical sites across Taiwan, Sweden, and the United States, targeting approximately 210 participants.
Twenty sites across three countries anchor the trial's design
The study includes nine medical centers in Taiwan, seven sites in Sweden, and four centers in the United States, with Taiwan forming the largest single group of participating sites. The randomized, double-blind, placebo-controlled trial will assign patients to TML-6 100 mg, TML-6 200 mg, or placebo, administered once daily for 52 weeks.
Trial targets the autophagy-lysosomal pathway rather than amyloid alone
Unlike approved amyloid-clearing therapies, TML-6 is being investigated for its effects on the autophagy-lysosomal system, the cellular mechanism responsible for clearing and recycling damaged proteins in neurons and microglia. Preclinical work has examined its impact on amyloid-related pathology, oxidative stress, and inflammation. Dr. Ih-Jen Su, Founder and Chairman of Merry Life Biomedical, said the next generation of Alzheimer's therapeutics must address why neurons lose the ability to clear damaged proteins, not just what accumulates in the brain.
Endpoints combine cognitive scoring with four blood biomarkers
The primary endpoint is change from baseline in the Clinical Dementia Rating Sum of Boxes. Secondary endpoints include blood biomarkers p-Tau 217, Aβ, GFAP, and NfL. Henrik Zetterberg, MD, PhD, will support blood biomarker analyses, while Barbara B. Bendlin, PhD, will contribute amyloid PET and MRI imaging expertise. Gary W. Small, MD, serves as global medical consultant, and Jacobo Mintzer, MD, advises on global clinical site execution.
Swedish investigator with 40-plus trials joins Taiwan program
Anne Börjesson-Hanson, MD, PhD, of Karolinska Institute and Karolinska University Hospital, leads the seven Swedish sites. She has served in Sweden's Clinical Trial Network establishment and has acted as primary investigator in more than 40 global clinical trials. On October 4, she will visit Taiwan for the Taiwan Dementia Society Annual Scientific Meeting, delivering a plenary lecture and meeting with the nine Taiwanese principal investigators.
Company positions Phase 2 as inflection point for licensing talks
Merry Life Biomedical is moving from early-stage safety evaluation toward generating efficacy, biomarker, and imaging data through the trial. The company is exploring strategic investment, international venture capital, capital-market financing, and partnerships with global pharmaceutical companies. Depending on Phase 2 results and regulatory strategy, it will evaluate licensing, co-development, and other partnership models for late-stage development and commercialization, while planning Phase 3 development based on emerging data.