Merry Life Biomedical Co Ltd.

TAINAN, June 12, 2025 /PRNewswire/ -- Merry Life Biomedical Company announces the launch of its global Phase II clinical trial for TML-6, a novel oral small molecule drug targeting early-stage Alzheimer's disease (AD). TML-6 combines multiple mechanisms, including anti-oxidative effects (Nrf2 activation), melioration of autophagy function (autolysosomal activation), anti-amyloid accumulation (β-amyloid clearance), and anti-inflammatory effects (through NF-κB inhibition) through autolysosome pathway in neurons and microglia to remove intraneuronal and extracellular amyloid accumulation, representing the first in human multi-target strategy for AD treatment. The Phase I trial showed excellent safety, tolerability, and pharmacokinetics at 100–200 mg in both healthy and elderly adults. TML-6 will now advance to a Phase II 19 site trial across the United States, Sweden, and Taiwan after FDA approval. This 12-month study will enroll 210 patients with mild cognitive impairment (MCI) or mild dementia. Primary endpoints will include neuropsychological assessments (CDR-SB, iADRS) and blood biomarkers (p-Tau 217, Aβ42/40, NfL, GFAP), supported by brain MRI, amyloid PET scans, and ApoE genotyping. Type C FDA consultation for phase 2 trial design has completed on 13 May 2025, with trial initiation expected in April 2026, conducted by Syneos Health CRO. With its strong preclinical and clinical profile, TML-6 holds promise as both a monotherapy and in combination with anti-amyloid biologics, providing new hope for patients with Alzheimer's disease. About Merry Life Biomedical Company Merry Life Biomedical is a Taiwan-based biotechnology company focused on developing innovative therapies for neurodegenerative and age-related diseases. Leveraging advanced molecular design, pharmacological innovation, formulation optimization and global clinical development, the company is committed to addressing urgent unmet medical needs. Media Contact Dr. Ih-Jen Su Merry Life Biomedical Company, Ltd. Phone: +886-910-902-296 Email: [email protected] SOURCE Merry Life Biomedical Company, Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

TAINAN, June 7, 2024 /PRNewswire/ -- MLB (Merry Life Biomedical Company, Ltd., Taiwan: ), 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 Continue Reading 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 Trial s 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. Contact: Chien Hong Lin, PhD Email: [email protected] SOURCE Merry Life Biomedical Company, Ltd.