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FDA to Initiate Phase 1 Trial of TML-6, a New Era Multi-Target Drug for the Treatment of Alzheimer's Disease

Category: Press Releases
TML-6

MLB (Merry Life Biomedical Company, Ltd., a biomedical company, announced that the U.S. Food and Drug Administration (FDA) has approved IND application for TML-6, an novel drug to treat Alzheimer's disease (AD), enabling a Phase 1 clinical trial to be initiated this July. Advancing TML-6 into clinical trial is a critical milestone for MLB to develop a new era multi-target drug for AD since 2018.

About TML-6:


TML-6 is a novel synthetic curcumin analog. Professor Ih-Jen Su at Southern Taiwan University used a platform of 6 aging and AD biomarkers to screen the 12 compounds from Androscience (San Diego, USA) for AD candidate. Preclinical studies showed that TML-6 (ASC-6) exhibits a multi-target action mechanism for AD, including anti-aging, activation of autophagy (mTOR inhibitor), reducing amyloid accumulation, and anti-inflammation (Figure 1), the efficacy confirmed by 2 AD animal models. TML-6 has a high bioavailability through formulation and then completed preclinical toxicology and safety studies. TML-6 should be potentially a novel drug to improve or reverse the progression of early-stage AD.


The Design and Future Plan of TML-6 for AD Clinical Trials:


TML-6 is developed as an oral drug and will conduct a SAD/MAD phase 1 clinical trial at Glendale Adventist Medical Center, LA, USA in 2024 Q3. Elderly cohort and CSF pharmacokinetics (PK) studies were specifically designed. For a global multi-site phase 2a clinical trial, several distinguished global AD experts provided consultation. Blood biomarkers will be included in the phase 2a trial as the surrogate endpoint of efficacy. Furthermore, TML-6 is considering to combine with the current anti-amyloid drugs in phase 2 trial. The drug combination could not only exhibit synergistic effects to improve AD behavior, reducing amyloid accumulation and ant-inflammation, but can also reduce antibody dosing to only 10% and avoid the adverse events (ARIAs) of anti-body drugs. MLB has successfully raised funds to conduct this global phase 2a clinical trial, scheduled to be conducted on 2025 Q3.


Company Name: Merry Life Biomedical Company, Ltd.
About Company: Merry Life Biomedical Company, Ltd. (Merry Life/MLB) is committed to the development for the treatment of Alzheimer’s disease. We focus on global development of new medication based on unique patent portfolio, rigorous research efforts and professional management, moving toward the ultimate solution for the Alzheimer’s disease. Today in the 21st century, the sheer number of dementia population and Alzheimer’s disease patients has become tremendous burden on the society, but we are still struggling to come up with a successful new medicine despite years of efforts that the medical society has made. Thanks to the high-tech platform under our professional team, Merry Life has obtained TML-6 and secured its exclusive licensing, a rare and encouraging opportunity.
Person of Contact: Chien Hong Lin, PhD