NEWS

San Jose, CA, October 12, 2023 - Biomed Industries, Inc. (Biomed) is set to present an insightful research study on anti-amyloid drugs at the Clinical Trials in Alzheimer's Disease Conference (CTAD) in Boston, MA, from October 24 to 27, 2023. The study, titled "What Does Amyloid-beta (Aβ) Have to Do with Alzheimer's Disease: A History of Failure," will be presented by Dr. Zung Vu Tran, Vice President of Bioinformatics and AI.

Dr. Tran and his team undertook a comprehensive review and analysis of data from published clinical trials featuring drug treatments based on anti-Aβ monoclonal antibodies. Their analysis prioritized the most recent trial for each drug, focusing on treatments that have completed at least a phase 2 trial. Drugs reviewed included: aducanumab, bapineuzumab, crenezumab, donanemab, gantenerumab, lecanemab, ponezumab, semorinemab, and solanezumab. Notably, both lecanemab and aducanumab recently received FDA approval.

Dr. Tran commented on the study's findings: "The small mean differences for both CDR-SB and ADAS-Cog across the trials conducted with these nine monoclonal antibody drugs cannot be considered as either clinically or statistically significant for the treatment of Alzheimer's disease." He continued "We analyzed the collective evidence from clinical trials of monoclonal antibody drugs using bootstrap methodology. The results show that for the treatment of Alzheimer's disease, these anti-amyloid drugs do not appear to be have a measurable clinical effect. In addition, it is well-known that these drugs are associated with serious adverse events. We therefore conclude that for these trials, it has been essentially a history of failures."

These observations support the ruling of the Centers for Medicare & Medicaid Services (CMS) statement from April 7, 2022, which stated, "To date, no trial of an anti-amyloid mAb has confidently demonstrated a clinically meaningful improvement in health outcomes (i.e., cognition and function) for AD patients. Thus, there is insufficient evidence to conclude that the use of monoclonal antibodies directed against amyloid is reasonable and necessary for the treatment of Alzheimer's disease."

In light of the apparent failure of all anti-amyloid drugs, Biomed is championing a novel approach known as the Neurogenesis Hypothesis, positioned as a potential replacement to the amyloid hypothesis. At the CTAD conference, Biomed will also present a paper titled, "Neurogenesis Hypothesis and Clinical Trials of NA-831 for the Treatment of Alzheimer's Disease and Major Depressive Disorder."

Biomed's drug, NA-831 has demonstrated a proof of safety and efficacy as a potential disease-modifying drug for improving cognitive functions, and overall quality of life for patients with MCI and mild & moderate Alzheimer's disease.

The Company plans to conduct a Phase 2B/3 clinical trial of NA-831 for the treatment of Alzheimer's disease and major depressive disorder. The clinical results of NA-831 suggested that the Neurogenesis Hypothesis provides viable guidance for research in Alzheimer's disease and other neurodegenerative diseases.

About Biomed Industries, Inc.

Biomed Industries™, Inc. is a bio-pharmaceutical company committed to the development and commercialization of new drug therapeutics for unmet needs. Biomed is a leading innovator, having discovered a new family of clinical stage drugs for the treatment of Alzheimer's disease and other neurological disorders. The Company is also developing new applications of AI for drug discovery, clinical trials recruitment and execution, and other mission critical areas in the pharmaceutical and medical device industry.

CONTACT

Michael Willis
Biomed Industries, Inc.
San Jose, CA 95131 USA
Tel. 800-824-5135
Email: media@biomedind.com