traneurocin oral (NA-831) / Biomed Industries - LARVOL DELTA

Associations Between Alzheimer's (AD) and Obesity: Phase 2 of NA-831 for AD and NA-931for Obesity (OBESITY WEEK 2025) - P2 | "Both NA-831 and NA-931 showed promising clinical outcomes in their respective target populations, with unexpected weight loss benefits observed in the AD trial. These findings point to a potential biological link between Alzheimer's disease, obesity, and metabolic disorders like diabetes. Further research is warranted to clarify the nature and direction of this relationship."

P2 data • Alzheimer's Disease • Cardiovascular • CNS Disorders • Cognitive Disorders • Diabetes • Genetic Disorders • Mental Retardation • Metabolic Disorders • Movement Disorders • Obesity • Parkinson's Disease • Psychiatry • Schizophrenia • IGF1

Biomed Industries to Present Four Studies at AAIC 2025 on Breakthrough Alzheimer’s, Rett Syndrome, and Obesity Therapies (Firstwordpharma Press Release) - "Biomed Industries...announced it will present four major scientific papers at the Alzheimer’s Association International Conference (AAIC), taking place July 27–31, 2025, in Toronto, Canada...Featured AAIC 2025 Presentations: 1. The End of the Amyloid Era? Evidence for a Paradigm Shift in the Quest to Treat Alzheimer’s Disease; 2. A Phase 3 Clinical Protocol of NA-831 Combined with Donanemab in Early Alzheimer’s Disease: A Placebo-Controlled, Double-Blind Study; 3. Associations Between Alzheimer’s Disease and Rett Syndrome: Clinical Trials of NA-831 and NA-921; 4. Neuro-Metabolic Link Between Alzheimer’s Disease and Obesity: Clinical Evaluation of NA-831 and NA-931"

Clinical protocol • Trial status • Alzheimer's Disease • CNS Disorders • Obesity

Developing Topics. (PubMed, Alzheimers Dement) - "The Neurogenesis Hypothesis has been shown to be a viable approach for further research for Alzheimer's disease and Major Depressive Disorder. Phase 3 trials of NA-831 for the treatment of AD and MDD are being conducted. Results of the clinical trials will be provided as soon as they are available."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Developing Topics. (PubMed, Alzheimers Dement) - "An association of Alzheimer's disease and diabetes obesity has been suggested with clinical results of NA-831 and NA-931. However, whether this association is causal requires further evaluation."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Diabetes • Genetic Disorders • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity • IGF1

Developing Topics. (PubMed, Alzheimers Dement) - "An association of Alzheimer's disease and stroke has been suggested with clinical studies of NA-831 and NA-911. However, whether this association is causal requires further evaluation."

Clinical • Journal • Alzheimer's Disease • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • IGF1

Developing Topics. (PubMed, Alzheimers Dement) - "The Phase 3 clinical trial will be conducted more than 30 sites in the US and several countries. The details of the Phase 3 methodology and protocol will be presented and discussed."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

Neurogenesis Hypothesis- Clinical Trials of NA-831 for Alzheimer's Disease and NA-901 for Major Depressive Disorder (CTAD 2024) - No abstract available

Clinical • Late-breaking abstract • Alzheimer's Disease • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Combination Therapy Phase 3 Protocol: Placebo-Controlled, Double-Blind, Parallel-Group to Study the Safety and Efficacy of NA-831 in Combination with Lecanemab in Subjects with Early Alzheimer's Disease (CTAD 2024) - No abstract available

Clinical • Combination therapy • Late-breaking abstract • P3 data • Alzheimer's Disease • CNS Disorders

NA-831: Phase 2 Clinical Trials for Alzheimer’s Disease (EIN Presswire) - P2 | N=126 | NCT03538522 | Sponsor: Biomed Industries, Inc. | "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."

P2 data • Alzheimer's Disease • CNS Disorders

Biomed Industries, Inc. to Present Five Pivotal Papers on Alzheimer’s Disease Therapy at AAIC 2024-Philadelphia (EIN Presswire) - "Biomed Industries, Inc. (Biomed), a leading biopharmaceutical company, announced today that it will present five scientific papers at the Alzheimer’s Association International Conference (AAIC) from July 28 to August 1, 2024, in Philadelphia. The papers to be presented include: Phase 3 Clinical Protocol: A placebo-controlled, double-blind, parallel-group study evaluating the safety and efficacy of NA-831 in combination with Lecanemab in subjects with early Alzheimer’s Disease...Phase 2 Clinical Trials of NA-831: Supporting the Neurogenesis Hypothesis in treating Alzheimer’s Disease and Major Depressive Disorder. Associations Between Alzheimer’s Disease and Obesity: Clinical studies on NA-831 for AD and NA-931 for obesity. Associations Between Alzheimer’s Disease and Stroke: Clinical studies on NA-831 for AD and NA-911 for stroke."

Clinical data • Clinical protocol • P2 data • Alzheimer's Disease • CNS Disorders • Metabolic Disorders • Obesity

Phase 3 Clinical Protocol: Placebo-Controlled, Double-Blind, Parallel-Group to Study Safety and Efficacy of NA-831 in Combination with Lecanemab in Subjects with Early Alzheimer's Disease (AAIC 2024) - "The Phase 3 clinical trial will be conducted more than 30 sites in the US and several countries. The details of the Phase 3 methodology and protocol will be presented and discussed."

Clinical • Clinical protocol • Combination therapy • P3 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

Associations Between Alzheimer’s Disease and Obesity: Clinical Trials of NA-831 for AD and NA-931 for Obesity (AAIC 2024) - "An association of Alzheimer’s disease and diabetes obesity has been suggested with clinical results of NA-831 and NA-931. However, whether this association is causal requires further evaluation."

Clinical • Alzheimer's Disease • CNS Disorders • Diabetes • Genetic Disorders • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity • IGF1

Phase 2 Clinical Trials of NA-831 for the Treatment of Alzheimer’s Disease and Major Depressive Disorder, support the Neurogenesis Hypothesis (AAIC 2024) - "The Neurogenesis Hypothesis has been shown to be a viable approach for further research for Alzheimer’s disease and Major Depressive Disorder. Phase 3 trials of NA-831 for the treatment of AD and MDD are being conducted. Results of the clinical trials will be provided as soon as they are available."

Clinical • P2 data • Alzheimer's Disease • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Associations Between Alzheimer’s Disease and Stroke: Clinical Studies of NA-831 for AD and NA-911 for Stroke (AAIC 2024) - "An association of Alzheimer’s disease and stroke has been suggested with clinical studies of NA-831 and NA-911. However, whether this association is causal requires further evaluation."

Clinical • Alzheimer's Disease • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • IGF1

A PHASE 2 CLINICAL PROTOCOL TO CONFIRM THE SAFETY AND EFFICACY OF NA-831 IN COMBINATION WITH ADUCANUMAB IN SUBJECTS WITH EARLY ALZHEIMER'S DISEASE (ADPD 2024) - "The results of the study will be available in 2025. The details of the Phase 2 methodology and protocol will be presented and discussed."

Clinical • Clinical protocol • Combination therapy • P2 data • Alzheimer's Disease • CNS Disorders

A PHASE 3 CLINICAL PROTOCOL TO STUDY THE SAFETY AND EFFICACY OF NA-831 IN COMBINATION WITH LECANEMAB IN SUBJECTS WITH EARLY ALZHEIMER'S DISEASE (ADPD 2024) - "The results of the phase 3 study will be availlabe in 2025. The details of the Phase 3 methodology and protocol will be presented and discussed."

Clinical • Clinical protocol • Combination therapy • P3 data • Alzheimer's Disease • CNS Disorders

NEUROGENESIS AND CLINICAL TRIALS OF NA-831 FOR ALZHEIMER'S DISEASE AND MAJOR DEPRESSIVE DISORDER (ADPD 2024) - "The Neurogenesis Hypothesis has been shown to be a viable approach for further research for Alzheimer's disease (AD) and Major Depressive Disorder (MDD)."

Clinical • Alzheimer's Disease • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Neurogenesis Hypothesis and Clinical Trials of NA-831 for the Treatment of Alzheimer's Disease and Major Depressive Disorder (CTAD 2023) - "Venlafaxine XR was used as the active reference. The Neurogenesis Hypothesis has been shown to be a viable approach for further research for Alzheimer’s disease (AD) and Major Depressive Disorder (MDD). Biomed is in the process of conducting a Phase 2B and Phase 3 trials of NA-831 for the treatment of AD and MDD."

Clinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Depression • Major Depressive Disorder • Mood Disorders • Pain • Psychiatry • Xerostomia

A Phase 3 Clinical Protocol: Placebo-Controlled, Double-Blind, Parallel-Group to Confirm Safety and Efficacy of NA-831 in Combination with Lecanemab in Subjects with Early Alzheimer's Disease (CTAD 2023) - "The Phase 3 clinical trial will be conducted more than 30 sites in the US and several countries. The details of the Phase 3 methodology and protocol will be presented and discussed."

Clinical • Clinical protocol • Combination therapy • P3 data • Alzheimer's Disease • Cardiovascular • CNS Disorders • Cognitive Disorders • Dementia • Depression • Epilepsy • Major Depressive Disorder • Mental Retardation • Psychiatry

A Phase 2 Clinical Protocol: Placebo-Controlled, Double-Blind, Parallel-Group to Confirm Safety and Efficacy of NA-831 in Combination with Aducanumab in Subjects with Early Alzheimer's Disease (CTAD 2023) - "The Phase 2 clinical trial will be conducted more than 20 sites in the US and several countries. The details of the Phase 2 methodology and protocol will be presented and discussed."

Clinical • Clinical protocol • Combination therapy • P2 data • Alzheimer's Disease • Cardiovascular • CNS Disorders • Cognitive Disorders • Dementia • Depression • Epilepsy • Major Depressive Disorder • Mental Retardation • Psychiatry

A PHASE 3 CLINICAL TRIAL PROTOCOL TO EVALUATE THE EFFICACY AND SAFETY OF NA-831 IN SUBJECTS WITH EARLY ONSET OF ALZHEIMER'S DISEASE (ADPD 2023) - "The Phase 3 clinical trial are being conducted in 25 sites in the US and several countries. The details of the Phase 3 methodology and protocol will be presented and discussed."

Clinical • P3 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

AMYLOID HYPOTHESIS & NEUROGENESIS HYPOTHESIS: A CASE STUDY OF PHASE 2A CLINICAL TRIALS OF NA-831 FOR THE TREATMENT OF ALZHEIMER'S DISEASE (ADPD 2023) - "Conclusions NA-831 has been demonstrated a proof of safety and efficacy as a potential disease-modifying drug for improving cognitive functions for patients with MCI and mild & moderate Alzheimer's disease. The Neurogenesis Hypothesis is a viable guidance for research in Alzheimer's disease"

Clinical • P2a data • Alzheimer's Disease • CNS Disorders • BDNF

NEUROGENESIS HYPOTHESIS WITH A CASE STUDY- PHASE 2A CLINICAL TRIALS RESULTS OF NA-831 FOR THE TREATMENT OF ALZHEIMER’S DISEASE. (CTAD 2022) - "NA-831 provided a significant delay in cognitive decline in MCI as measured by ADAS-Cog-13, an average score difference of 3.4 compared to placebo (p = 0.01; ITT) after 24 weeks of treatment. Similarly, NA-831 delayed cognitive decline in early AD, an average score difference of 4.1 com-pared to placebo (p = 0.001; ITT). CIBICPlus showed 78 % of the study participants receiving NA-831 improved (p = 0.01; ITT)."

Clinical • P2a data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • BDNF • PCNA

A PHASE 3 CLINICAL TRIAL PROTOCOL TO EVALUATE THE EFFICACY AND SAFETY OF NA-831 IN SUBJECTS WITH EARLY ONSET OF ALZHEIMER’S DISEASE. (CTAD 2022) - "The details of the Phase 3 methodology and protocol will be presented and discussed. All abstracts are embargoed until the day and time of presentation at the CTAD Conference S73"

Clinical • P3 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

A Phase 3 Clinical Trial Protocol to Evaluate the Efficacy and Safety of NA-831 in Subjects with Early Onset of Alzheimer's Disease (AAIC 2022) - No abstract available

Clinical • P3 data • Alzheimer's Disease • CNS Disorders