The US Food and Drug Administration (FDA) has granted clearance for Merry Life Biomedical’s (MLB) investigational new drug (IND) application to commence a Phase I clinical trial of TML-6, a new drug aimed at treating Alzheimer’s disease (AD).
This development marks a significant step for the company, which has been developing this multi-target drug since 2018.
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The company plans to commence the Phase I trial of the Alzheimer’s drug next month.
The Phase I trial, involving single ascending dose/multiple ascending dose (SAD/MAD) studies, will be conducted at Glendale Adventist Medical Center in Los Angeles, US, in the third quarter of this year.
Specifically designed for the elderly cohort, the trial will also include cerebrospinal fluid pharmacokinetics (PK) studies.
A synthetic curcumin analog, TML-6 was identified using a platform of six aging and AD biomarkers to monitor 12 compounds from Androscience for potential AD treatment.
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By GlobalDataPreclinical studies have demonstrated that TML-6 possesses a multi-target mechanism of action against AD, such as anti-ageing, autophagy activation, lowering amyloid buildup and anti-inflammation.
Furthermore, its efficacy was validated in two animal models of AD.
Developed as an oral medication, the drug has shown high bioavailability and completed preclinical toxicology and safety studies.
It offers the potential to improve or even reverse the progression of early-stage AD.
For the subsequent Phase IIa global multi-site trial, MLB plans to incorporate blood biomarkers as surrogate endpoints for efficacy.
Moreover, TML-6 is being considered for use in combination with current anti-amyloid drugs in the Phase II trial.
This combination regimen is anticipated to enhance the therapeutic effects, reduce amyloid accumulation and mitigate inflammation while potentially lowering antibody dosing to 10% and avoiding the adverse events associated with antibody drugs.
MLB has secured funding to conduct the global Phase IIa clinical trial, which is scheduled for the third quarter of next year.
