Breakthrough Clinical Results
Tiziana Life Sciences announced positive advancements in moderate Alzheimer's disease treatment using intranasal foralumab, a fully human anti-CD3 monoclonal antibody. A recent interview featured a patient, Joe Walsh, who experienced a transformative improvement after receiving the treatment. Dr. Howard Weiner highlighted the reduction in brain inflammation observed in Mr. Walsh as a significant step forward. Foralumab is also being studied in a Phase 2a trial for non-active secondary progressive multiple sclerosis.
Key Highlights
- Positive results from a patient with moderate Alzheimer's disease treated with intranasal foralumab.
- Intranasal foralumab targets brain inflammation, a key contributor to Alzheimer's progression.
- Foralumab is also in a Phase 2a trial for non-active secondary progressive multiple sclerosis.
- The treatment shows promise in improving cognitive function and engagement in social activities.
Incidence and Prevalence
Global Estimates of Alzheimer's Disease Incidence and Prevalence
Alzheimer's disease (AD) is the most common cause of dementia, accounting for 50% to 60% of cases. It is the most common form of age-related dementia and the most common cause of dementia worldwide.
In the United States, AD affects nearly 6 million people. The disease impacts approximately one-half of Americans older than 85 years. In France, Alzheimer's disease affects nearly 300,000 people.
The disease generally begins after 60 years of age, and its prevalence increases markedly after age 75 years. Due to the increasing elderly population in all Western countries, Alzheimer's disease constitutes a "veritable emergent public health problem".
AD is considered a major health problem given the current increase in the geriatric population all over the world.
Emerging Mechanism of Action
Emerging Mechanisms of Action for Alzheimer's Disease
Amyloid-targeting approaches
Anti-amyloid antibodies have shown promise in slowing cognitive decline during the mildly symptomatic phase of Alzheimer's disease (AD). Various pharmacological approaches aim to reduce β-amyloid peptide formation by inhibiting β-secretase and γ-secretase enzymes. Both passive and active immunotherapies have been developed to inhibit β-amyloid peptide aggregation. However, some γ-secretase inhibitors (tarenflurbil, semagacestat) were discontinued due to lack of efficacy or side effects.
Tau-targeting approaches
Another significant focus has been addressing phosphorylated MAPT/tau aggregates that form neurofibrillary tangles. Celastrol, a natural small molecule, has shown promise as a TFEB activator that enhances autophagy and lysosomal biogenesis. Celastrol promotes degradation of phosphorylated MAPT/tau aggregates in cells and animal brains. This approach alleviates memory deficits in AD animal models.
Autophagy-lysosomal pathway (ALP)
Enhancing TFEB-mediated autophagy and lysosomal biogenesis to degrade tau aggregates represents another emerging mechanism. TFEB (transcription factor EB) regulates multiple autophagy and lysosomal-related genes. A compromised autophagy-lysosomal pathway has been implicated in AD progression.
Non-pharmacological interventions
Repetitive transcranial magnetic stimulation (rTMS) has shown encouraging results for improving or stabilizing cognition. A large placebo-controlled double-blind study is investigating short- and long-term benefits of active rTMS.
Other emerging approaches
Granulocyte-colony stimulating factor (G-CSF) has shown neuroprotective functions. G-CSF may protect spatial memory by suppressing TRAIL-mediated neuronal apoptosis. Traditional Chinese medicine (TCM) has shown therapeutic effects for improving cognition in mild to moderate AD.
Drug used in other indications
Based on the provided context, there is no information available about Foralumab being trialled for Alzheimer's disease or any other indications. The context does not contain any details about Foralumab, its clinical trials, or intervention models.
The context mentions several other treatments for Alzheimer's disease, including:
- Aducanumab
- Solanezumab
- Gantenerumab
- Crenezumab
- Donanemab
- Bapineuzumab
- Donepezil
- Florbetapir (as a diagnostic agent)
- Lecanemab
- Statins (including atorvastatin, simvastatin, pravastatin, and rosuvastatin)
However, no information about Foralumab appears in the provided context, so it is not possible to address the queries about which indications Foralumab is being trialled for or what intervention models are being used in these trials.