TML-6 / AndroScience, Merry Life Biomedical - LARVOL DELTA

A Phase 1 Safety and Tolerability Study of TML-6 in Healthy and Elderly Volunteers for Alzheimer's Disease Treatment (clinicaltrials.gov) - P1 | N=72 | Completed | Sponsor: Merry Life Biomedical Co., Ltd. | Recruiting ➔ Completed | Trial primary completion date: Apr 2025 ➔ Jul 2025

Trial completion • Trial primary completion date • Alzheimer's Disease • CNS Disorders

New Alzheimer's drug TML-6 starts Phase II clinical trial in Taiwan and the U.S. [Google translation] (Virginia Contract Research Organization (VCRO)) - "Completed human clinical trials of health formula with preventive potential...Can improve and prevent Alzheimer's disease To further confirm the human efficacy of the Alzheimer's health formula, the health product was clinically tested in three medical centers in Taiwan by Victoria Biotech (CRO company). After six months of follow-up, the clinical trial of 53 subjects was unblinded in May 2025."

Trial status • Alzheimer's Disease

Merry Life Launches Global Phase II Trial of TML-6, The First Drug Targeted at Autolysosome pathway for Therapy of Alzheimer's Disease (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....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."

New P2 trial • Alzheimer's Disease

Drug Development. (PubMed, Alzheimers Dement) - "TML-6 exhibits a multi-target action mechanism meeting the new era strategy to develop AD drug. The combined data of phase 1 trial and 9-month chronic toxicology in dogs will be applied to US FDA for global phase 2a trial, with integration of blood biomarkers. We look forward to the success of TML-6 in clinical trials that will provide an ideal therapy, with potential of combining with anti-amyloid drug, for Alzheimer's disease."

Journal • Alzheimer's Disease • CNS Disorders • Inflammation • APOE

A Phase 1 Safety and Tolerability Study of TML-6 in Healthy and Elderly Volunteers for Alzheimer's Disease Treatment (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Merry Life Biomedical Co., Ltd.

New P1 trial • Alzheimer's Disease • CNS Disorders

Design of A Phase 1 Trial for Safety, Tolerability, Single-ascending Dose, Multiple-ascending Dose, Food Effect, and Pharmacokinetic Study of TML-6, A Novel Oral Multi-Target Drug, in Healthy Volunteers (AAIC 2024) - "TML-6 exhibits a multi-target action mechanism meeting the new era strategy to develop AD drug. The combined data of phase 1 trial and 9-month chronic toxicology in dogs will be applied to US FDA for global phase 2a trial, with integration of blood biomarkers. We look forward to the success of TML-6 in clinical trials that will provide an ideal therapy, with potential of combining with anti-amyloid drug, for Alzheimer’s disease."

Clinical • P1 data • PK/PD data • Alzheimer's Disease • CNS Disorders • Inflammation • APOE

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 (PRNewswire) - "MLB...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....Furthermore, TML-6 is considering to combine with the current anti-amyloid drugs in phase 2 trial....MLB has successfully raised funds to conduct this global phase 2a clinical trial, scheduled to be conducted on 2025 Q3."

IND • New P1 trial • New P2a trial • Alzheimer's Disease • CNS Disorders