{"id":27008,"date":"2024-06-07T07:00:00","date_gmt":"2024-06-07T07:00:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4434224_AE34224_0"},"modified":"2024-06-07T07:00:00","modified_gmt":"2024-06-07T07:00:00","slug":"mlb-announces-ind-approval-by-us-fda-to-initiate-phase-1-trial-of-tml-6-a-new-era-multi-target-drug-for-the-treatment-of-alzheimers-disease","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=27008","title":{"rendered":"MLB Announces IND Approval by US FDA to Initiate Phase 1 Trial of TML-6, a New Era Multi-Target Drug for the Treatment of Alzheimer’s Disease"},"content":{"rendered":"\n

TAINAN, June 7, 2024<\/span> \/PRNewswire\/ — MLB (Merry Life Biomedical Company, Ltd., Taiwan<\/span>: https:\/\/www.tmlbio.com\/<\/a>), a biomedical company, announced that the U.S. Food and Drug Administration (FDA) has approved IND application for TML-6<\/b>, an novel drug to treat Alzheimer’s disease (AD)<\/b>, 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<\/b> drug for AD since 2018.<\/p>\n

\n

\"\"<\/a>
<\/span><\/p>\n<\/p><\/div>\n

About TML-6<\/b><\/p>\n

TML-6<\/b> is a novel synthetic curcumin analog. Professor Ih-Jen Su<\/span> at Southern Taiwan<\/span> University used a platform of 6 aging and AD biomarkers to screen the 12 compounds from Androscience (San Diego<\/span>, USA<\/span>) for AD candidate. Preclinical studies showed that TML-6<\/b> (ASC-6) exhibits a multi-target<\/b> 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<\/b> has a high bioavailability<\/b> through formulation and then completed preclinical toxicology and safety studies. TML-6<\/b> should be potentially a novel drug to improve or reverse<\/b> the progression of early-stage AD.<\/p>\n

The Design and Future Plan of TML-6 for AD Clinical Trial<\/b>s<\/b><\/p>\n

TML-6<\/b> 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<\/b> 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<\/b> 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.<\/p>\n

Contact:
<\/b>Chien Hong Lin<\/span>, PhD
Email: rd07@tmlbio.com<\/a><\/p>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

TAINAN, June 7, 2024 \/PRNewswire\/ — MLB (Merry Life Biomedical Company, Ltd., Taiwan: https:\/\/www.tmlbio.com\/), 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. 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