Biomed Industries Unveils a New Neurogenesis Hypothesis with Clinical Data for Alzheimer's and Depression Treatment
Biomed Industries, Inc. Unveils a New Neurogenesis Hypothesis with Clinical Data of NA-831 for Alzheimer's and NA-901 for Major Depressive Disorder Treatment
Biomed Industries, Inc. (Biomed) today announced that Dr. Lloyd Tran, CEO, delivered a keynote address at the Neurology World Conference, held from September 4-6, 2024, in San Francisco, CA.
Dr. Tran’s presentation highlighted the company’s cutting-edge research on the Neurogenesis Hypothesis and clinical trials of its drug candidates NA-831 aimed at treating Alzheimer’s Disease (AD) and NA-901, and NA-901 for teh treatment of Major Depressive Disorder (MDD). His address shed light on Biomed’s groundbreaking discovery of the pivotal role neurogenesis plays in combating neurodegenerative diseases and depression.
The Amyloid Hypothesis: Rethinking the Paradigm
For over 30 years, the Amyloid Hypothesis has been the cornerstone of Alzheimer’s disease research, suggesting that amyloid-beta (Aβ) plaques are the primary cause of neurodegeneration in AD. Despite its dominance in the field, nearly all phase 3 AD drug trials based on this hypothesis have failed.
One notable challenge to the Amyloid Hypothesis is the discovery of high levels of Aβ in non-demented elderly individuals. While the hypothesis argues that Aβ plaques damage neurons, leading to dementia, Aβ is present in various tissues, including the brain, skin, muscles, and intestines. In its soluble form, Aβ plays essential roles in human physiology, including:
- Antimicrobial defense
- Tumor suppression
- Repairing leaks in the blood-brain barrier (BBB)
- Promoting brain recovery from injuries
- Regulating synaptic function and memory consolidation
Numerous clinical trials aimed at depleting Aβ have produced disappointing results, often resulting in “Amyloid-Related Imaging Abnormalities (ARIA)”—brain edema, micro-hemorrhages, and cognitive confusion. Despite FDA approval for anti-amyloid drugs like Aducanumab, Lecanemab, and Donanemab, these treatments reduce amyloid plaques without improving cognitive function, casting doubt on the Amyloid Hypothesis.
The Neurogenesis Hypothesis: A Revolutionary Approach
Biomed is advancing the “Neurogenesis Hypothesis”, which posits that Adult Hippocampal Neurogenesis (AHN) —the generation of new neurons in the brain—plays a crucial role in both Alzheimer’s and depressive disorders. Impairments in AHN compromise the hippocampus, a brain region central to memory and cognitive function, and are evident in patients with AD and its precursor, mild cognitive impairment (MCI).
“The hippocampus continues to produce new neurons into the tenth decade of life, even in patients with Alzheimer’s,” said Dr. Lloyd Tran, CEO of Biomed Industries. “Our research indicates that AHN impairment occurs before the formation of amyloid plaques and neurofibrillary tangles, the hallmark signs of AD. We believe our orally-administered drugs, NA-831 for Alzheimer’s and NA-901 for depression, represent a major advancement in targeting neurogenesis for treating these conditions.”
NA-831 and NA-901: Pioneering New Therapies
NA-831: Phase 2 Clinical Trials for Alzheimer’s Disease
In a phase 2 trial involving 112 participants with mild to moderate Alzheimer’s, patients received either NA-831 or a placebo for 24 weeks. The results were compelling: NA-831 significantly improved cognition, with an ADAS-Cog-13 score improvement of 4.1 points (p = 0.001). Additionally, CIBIC-Plus assessments indicated that 78% of treated patients showed improvement (p = 0.01). NA-831 was well-tolerated, with no serious adverse events.
NA-901: Phase 1B Clinical Trials for Major Depressive Disorder (MDD)
A phase 1B, randomized, double-blind, placebo-controlled study of NA-901 in 32 patients with MDD demonstrated significant efficacy in reducing depressive symptoms. The MADRS score improved by an average of seven points compared to placebo, a difference far exceeding that of many approved antidepressants. NA-901 was well tolerated, with only mild side effects, including headaches and dry mouth.
A New Frontier in Neurological Treatment
“We believe the “Neurogenesis Hypothesis” offers a promising new direction for Alzheimer’s and depression research,” stated Dr. Tran. “Guided by this hypothesis, NA-831 and NA-901 have demonstrated significant safety and efficacy in clinical trials. These therapies could redefine treatment options for patients with Alzheimer’s disease and Major Depressive Disorder, and we’re excited to continue advancing this groundbreaking approach.”
About Biomed Industries, Inc.
Biomed Industries, Inc. is a pioneering biopharmaceutical company focused on developing innovative therapeutics to address unmet medical needs. The company’s research efforts have led to the development of novel drugs targeting Alzheimer’s disease, Major Depressive Disorder, diabetes, obesity, Metabolic Dysfunction-Associated Steatohepatitis (MASH), stroke, and rare diseases like Rett Syndrome and Fragile X Syndrome.
Lloyd L. Tran
Biomed Industries, Inc.
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