NeuroAiD(TM)II holds promise as a safe add-on therapy to standard Alzheimer Disease symptomatic treatments and may have a disease modifying effect by delaying disease progression

SINGAPORE,Jan. 13,2022 -- Moleac is pleased to announce the release of the ATHENE study results,published in the Journal of the American Medical Director Association (JAMDA)1.

Alzheimer's Disease (AD) and other dementias cause a heavy economic and public healthcare burden worldwide. The number of people living with dementia continues to increase mainly due to population aging and growth. Current approved treatments for AD are symptomatic and do not appear to affect disease progression.

Treatments that could effectively slow the course of AD once it has reached the clinical stage,remain an important unmet medical need. NeuroAiD™II has shown to have modulatory effects on amyloid precursor protein (APP) processing2 and the transformation of tau protein into abnormally phosphorylated and aggregated forms3,as well as neuro-regenerative and neuro-restorative properties4. The beneficial effects of NeuroAiD™II on impaired cognitive functions have already been demonstrated in traumatic brain injury5.

The Alzheimer's disease Therapy with NEuroaid (ATHENE) Study is the first study to assess the safety and efficacy of NeuroAiD™II in mild to moderate AD patients stable on standard symptomatic treatments.

ATHENE was a 6-month randomized double-blind,placebo-controlled trial followed by an open label extension of NeuroAiD™II treatment for another 6 months. 125 subjects from Singapore were included in the trial,which was coordinated by the Memory Ageing and Cognition Centre,National University Health System,National Neuroscience Institute,and St. Luke's Hospital,Singapore.

NeuroAiD™II showed long-term safety as an add-on therapy in AD with no increase of patients experiencing either serious adverse events or adverse events.

Early initiation of NeuroAiD™II provided long-term improvement of cognition compared to placebo (late starter group) measured by the ADAS-cog,statistically significant at 9 months,and slowing down the decline over time.

ATHENE study results support the benefit of NeuroAiD™II as a safe add-on therapy to standard AD treatment as the study found no evidence of a significant increase in adverse events between MLC901 and placebo. Analyses suggest the potential of MLC901 in slowing down AD progression which is consistent with previously published preclinical and clinical studies,making it a promising therapy for AD patients. These results require further confirmation in larger and longer studies.

A word from the Principal Investigator

"Alzheimer's Disease is the most common cause of dementia,accounting for 60-80% of cases. Until the recent approval of aducanumab by the FDA,there was no disease modifying treatment for Alzheimer's Disease,and the currently available symptomatic treatments seek to temporarily delay the worsening of dementia symptoms and improve the quality of life for those with Alzheimer's and their caregivers. Hence,there is a need to offer patients and their caregivers early access to diagnosis and novel treatments.

The promising results of the ATHENE study should be understood as part of the Alzheimer's Disease drug development pipeline's shift from symptomatic towards disease modifying therapies. This study and other potential treatments should be rigorously assessed by well-designed clinical trials."

Professor Christopher Chen

Director,Memory Aging and Cognition Centre,National University Health System and Associate Professor,Department of Pharmacology,Yong Loo Lin School of Medicine,National University of Singapore.

About Moleac

Moleac is a biopharmaceutical company committed to helping patients and their families reconnect with their lives. We address unmet needs of patients suffering from a loss of brain functions after a brain injury or neurodegenerative diseases. Our focus is to help them regain and maintain independence. We select scientifically proven natural compounds and formulations with origins in traditional medicine,establish their clinical properties,and make them available internationally.

1. Chen C,et al. Alzheimer's Disease THErapy With NEuroaid (ATHENE): ARandomized Double-Blind Delayed-Start Trial.Journal of the American Medical Directors Association 2021.DOI: 10.1016/j.jamda.2021.10.018

2. Lim YA,et al. NeuroAiD (MLC601) and Amyloid Precursor Protein Processing.Cerebrovasc Dis 2013.DOI: 10.1159/000346236

3. Lee WT,et al. The effects of MLC901 on tau phosphorylation.NeuroReport 2017.DOI: 10.1097/WNR.0000000000000884

4. Heurteaux C,et al. Neuroprotective and neuroproliferative activities of NeuroAiD (MLC601,MLC901),a Chinese medicine,in vitro and in vivo.Neuropharmacology 2010.DOI: 10.1016/j.neuropharm.2010.01.001

5. Theadom A,et al. MLC901 (NeuroAiD II™) for cognition after traumatic brain injury: a pilot randomized clinical trial.Eur J Neurol2018. DOI: 10.1111/ene.13653

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