Merry Life Biomedical Advances Global Phase 2 Trial of TML-6, Exploring Cellular Protein Clearance in Early Alzheimer's Disease

Global study brings together nine Taiwan medical centers, seven Swedish sites, and four U.S. centers to evaluate an oral therapy focused on autolysosomal biology

TAIPEI, Sept. 22, 2026 /PRNewswire/ -- Merry Life Biomedical today announced the advancement of TML-6, a Taiwan-developed investigational oral therapy for early Alzheimer's disease, into a global Phase 2 study spanning Taiwan, Sweden, and the United States.

The study brings together 20 clinical sites, including nine medical centers in Taiwan, seven sites in Sweden, and four centers in the United States. It will evaluate TML-6 in approximately 210 participants with early Alzheimer's disease.

A New Approach to Alzheimer's Disease

Alzheimer's disease is characterized by the abnormal accumulation of proteins in and around brain cells, including amyloid plaques and tau tangles. Recently approved therapies have demonstrated that removing amyloid can slow clinical decline in people with early Alzheimer's disease. But even with treatment, the disease continues to progress.

TML-6 is being investigated through a new and potentially complementary approach. Research on TML-6 has increasingly focused on the autophagy–lysosomal pathway, which is responsible for clearing and recycling proteins and other cellular material. Preclinical studies have investigated its effects on autophagy lysosomal function in neurons and microglia, together with amyloid related pathology, oxidative stress, and inflammation.

"The next generation of Alzheimer's therapeutics must look beyond what accumulates in the brain and ask why neurons lose their ability to clear damaged proteins and maintain normal function," said Dr. Ih-Jen Su, Founder and Chairman of Merry Life Biomedical. "Research on TML-6 has increasingly pointed us toward the autophagy–lysosomal system, a fundamental cellular pathway for clearing and recycling damaged proteins and cellular components. This global Phase 2 study will test whether targeting this biology can translate into meaningful benefit for patients."

Swedish Alzheimer's Clinical Trial Expertise Comes to Taiwan

A major international component of the TML-6 program is the participation of seven clinical sites in Sweden, working with Anne Börjesson-Hanson, MD, PhD, of Karolinska Institute and Karolinska University Hospital.

Dr. Börjesson-Hanson is an experienced investigator in international Alzheimer's clinical trials, including studies of emerging disease-modifying therapies. Her clinical trial experience includes serving as Sweden's Clinical Trial Network establishment and participated in more than 40 global clinical trial as primary investigator, as well as leadership roles in other international Alzheimer's studies.

On October 4, Dr. Börjesson-Hanson will visit Taiwan for the Taiwan Dementia Society Annual Scientific Meeting. She will deliver a plenary lecture and meet with the nine Taiwanese principal investigators participating in the TML-6 study.

Nine Taiwan Medical Centers Join the TML-6 Global Study

Nine major Taiwan medical centers are participating in the same global Phase 2 study alongside the Swedish and U.S. sites, making Taiwan the largest group of participating clinical sites in the program.

"For Taiwan's biotechnology sector, this represents more than the advancement of one molecule," Dr. Su said. "It is an opportunity for a therapeutic program developed in Taiwan to contribute to the global effort to understand and treat Alzheimer's disease through a new biological approach."

The randomized, double-blind, placebo-controlled study will enroll approximately 210 participants with early Alzheimer's disease. Participants will receive TML-6 100 mg, TML-6 200 mg, or placebo once daily for 52 weeks. The primary endpoint is change from baseline in the Clinical Dementia Rating Sum of Boxes, a measure of cognition and daily function, and blood biomarkers p-Tau 217, Aβ, GFAP, and NfL as secondary endpoints.

The study also brings together international expertise in Alzheimer's biomarkers, imaging, and clinical development. Henrik Zetterberg, MD, PhD, will support blood biomarker analyses, while Barbara B. Bendlin, PhD, will contribute expertise in amyloid PET and MRI analyses. Gary W. Small, MD, serves as a global medical consultant, and Jacobo Mintzer, MD, advises on global clinical site execution.

Global Phase 2 Marks a Key Value Inflection Point for Business Development and Licensing

With TML-6 advancing into global Phase 2 development, Merry Life Biomedical is moving beyond early-stage safety evaluation toward the generation of clinical efficacy, biomarker, and imaging data. The company views the global Phase 2 study as a key value inflection point and, based on study progress and emerging data, will plan for Phase 3 development and broader global development strategies. Merry Life Biomedical is also actively exploring strategic investment, international venture capital, capital-market financing, and partnerships with global pharmaceutical companies to accelerate subsequent development. In parallel, the company will continue discussions with international pharmaceutical companies and strategic partners and, subject to Phase 2 results and regulatory strategy, evaluate licensing, co-development, and other partnership models to advance TML-6 through late-stage clinical development and toward global commercialization.

Forward-Looking Statements

This press release contains forward-looking statements regarding TML-6 and its clinical development that are subject to risks and uncertainties inherent in drug development. Statements regarding TML-6's mechanism and potential effects reflect hypotheses under clinical investigation and do not establish safety or efficacy.