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APOE x APP x NF-κB x mTOR	1

AbstractBackgroundThese suggest that TML‐6’s ability to enter the brain parenchyma and possibly interact with and reduce Aβ, while possessing anti‐aging and anti‐inflammatory properties contributes to its effects on alleviating AD‐like pathology and behavioral deficit in APP/PS1 mice. Importantly, TML‐6 is safe and has promising drug bioavailability and exposure in pre‐clinical development. Taken together, TML‐6 exhibits promising druggability and meets the current strategy to develop as a first‐in‐class oral therapeutic drug for AD.MethodTML‐6 was applied to investigate the binding with Aβ peptide (1‐40 or 1‐42), hERG, and safety panel screening assay in vitro. Further, the effects of TML‐6 treatment on reducing AD‐like pathology, TML‐6 concentration in plasma‐to‐brain ratio, and inflammaging biomarkers in APP/PS1 mice were evaluated. Lastly, pharmacokinetic and toxicology studies in rats and dogs were performed.ResultData from pre‐clinical development showed that TML‐6 bound Aβ1‐40 and Aβ1‐42 in vitro and improved behavioral deficits with reduced inflammaging in AD model mice (e.g., TNF‐α, IL‐1β, & IL‐6). The TML‐6 levels in the plasm and brain tended to dose‐dependently increase in AD mice, which inversely correlated with behavioral deficits and AD‐like pathologies. TML‐6 was well tolerated in toxicology in rats and dogs and had no off‐target safety pharmacology issue by hERG & safety panel screening. Most importantly, formulation optimization of TML‐6 exerted satisfactory drug bioavailability and exposure.ConclusionThese suggest that TML‐6’s ability to enter the brain parenchyma and possibly interact with and reduce Aβ, while possessing anti‐aging and anti‐inflammatory properties contributes to its effects on alleviating AD‐like pathology and behavioral deficit in APP/PS1 mice. Importantly, TML‐6 is safe and has promising drug bioavailability and exposure in pre‐clinical development. Taken together, TML‐6 exhibits promising druggability and meets the current strategy to develop as a first‐in‐class oral therapeutic drug for AD.

International Journal of Molecular SciencesQ2 · BIOLOGY

The Beneficial Effects of Combining Anti-Aβ Antibody NP106 and Curcumin Analog TML-6 on the Treatment of Alzheimer’s Disease in APP/PS1 Mice

Q2 · BIOLOGY

ArticleOA

Author: Liang, Jia-Jun ; Hsu, Ying-Ting ; Su, Ih-Jen ; Shie, Feng-Shiun ; Hsu, Chia-Yu ; Hsu, John Tsu-An ; Shen, Santai ; Hsueh, Jung-Tsung ; Chao, Po-Kuan

Alzheimer’s disease (AD) is a progressive neurodegenerative disease with a multifactorial etiology. A multitarget treatment that modulates multifaceted biological functions might be more effective than a single-target approach. Here, the therapeutic efficacy of combination treatment using anti-Aβ antibody NP106 and curcumin analog TML-6 versus monotherapy was investigated in an APP/PS1 mouse model of AD. Our data demonstrate that both combination treatment and monotherapy attenuated brain Aβ and improved the nesting behavioral deficit to varying degrees. Importantly, the combination treatment group had the lowest Aβ levels, and insoluble forms of Aβ were reduced most effectively. The nesting performance of APP/PS1 mice receiving combination treatment was better than that of other APP/PS1 groups. Further findings indicate that enhanced microglial Aβ phagocytosis and lower levels of proinflammatory cytokines were concurrent with the aforementioned effects of NP106 in combination with TML-6. Intriguingly, combination treatment also normalized the gut microbiota of APP/PS1 mice to levels resembling the wild-type control. Taken together, combination treatment outperformed NP106 or TML-6 monotherapy in ameliorating Aβ pathology and the nesting behavioral deficit in APP/PS1 mice. The superior effect might result from a more potent modulation of microglial function, cerebral inflammation, and the gut microbiota. This innovative treatment paradigm confers a new avenue to develop more efficacious AD treatments.

1

News (Medical) associated with Merry Life Biomedical Co Ltd.

07 Jun 2024

·www.prnewswire.com

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

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.

Phase 2INDPhase 1

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100 Translational Medicine associated with Merry Life Biomedical Co Ltd.

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Pipeline

Pipeline Snapshot as of 23 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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