MLB Gets FDA IND Approval to Start Phase 1 Trial of Alzheimer's Drug TML-6

TAINAN, June 7, 2024 -- Merry Life Biomedical Company, Ltd. (MLB), a biomedical firm focused on innovative treatments, has announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for TML-6, a novel drug aimed at treating Alzheimer's disease (AD). This approval allows the company to commence a Phase 1 clinical trial in July, marking a significant milestone in MLB’s pursuit to develop a multi-target drug for AD since 2018.

About TML-6

TML-6 is a unique synthetic curcumin analog. Its development involved a collaborative effort led by Professor Ih-Jen Su from Southern Taiwan University. Using a platform comprising six aging and AD biomarkers, twelve compounds from Androscience (San Diego, USA) were screened to identify potential AD candidates. Preclinical studies revealed that TML-6 (ASC-6) showcases multiple mechanisms of action against AD, including anti-aging properties, activation of autophagy through mTOR inhibition, reduction of amyloid accumulation, and anti-inflammatory effects. These effects were validated through two distinct AD animal models. TML-6's high bioavailability was achieved through formulation, and comprehensive preclinical toxicology and safety studies have been completed, indicating significant potential to improve or reverse early-stage AD progression.

Design and Future Plans for TML-6 Clinical Trials

TML-6 will be administered orally and is set to undergo a Single Ascending Dose (SAD) / Multiple Ascending Dose (MAD) Phase 1 clinical trial at Glendale Adventist Medical Center in Los Angeles, USA, during the third quarter of 2024. The trial will include elderly cohorts and cerebrospinal fluid (CSF) pharmacokinetics studies. Planning for a global multi-site Phase 2a clinical trial is already underway, with advice from distinguished global AD experts. This phase will include blood biomarkers as surrogate endpoints to measure efficacy. Additionally, there are considerations to combine TML-6 with existing anti-amyloid drugs in the Phase 2 trial. This combination could potentially enhance synergistic effects, improving AD symptoms, reducing amyloid accumulation, and mitigating inflammation. Moreover, it may reduce antibody dosing to just 10%, thereby avoiding the adverse events (ARIAs) commonly associated with antibody drugs. MLB has successfully secured funding for this expansive Phase 2a clinical trial, which is expected to begin in the third quarter of 2025.

Merry Life Biomedical Company, Ltd. continues to advance its research and development efforts to bring innovative treatments to patients suffering from Alzheimer's disease, with TML-6 representing a promising step forward in the field of neurodegenerative disease treatment.

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