Tiziana Life Sciences' foralumab nasal spray shows promise in moderate Alzheimer's treatment.

Tiziana Life Sciences, a biotechnology company, announced advancements in moderate Alzheimer's disease treatment using its intranasal foralumab, a fully human anti-CD3 monoclonal antibody. Promising results were shared from the first patient, Joe Walsh, who received the treatment via nasal administration at Brigham and Women's Hospital. Foralumab is designed to combat brain inflammation, marking a step forward in moderate Alzheimer's research and treatment.

Eli Lilly and Company (NYSE: LLY) has announced that the Australian Therapeutic Goods Administration (TGA) has granted marketing authorization for Kisunla (donanemab), an intravenous infusion therapy for the treatment of early symptomatic Alzheimer's disease. This authorization is for adult patients who are Apolipoprotein E-ε4 heterozygotes or non-carriers, marking the 13th regulatory authorization for the drug [1].

Kisunla is designed to target and remove amyloid plaques, which are protein aggregates that can accumulate in the brain and contribute to the progression of Alzheimer's disease. The therapy has shown significant promise in clinical trials, including the TRAILBLAZER-ALZ 2 Phase 3 study, which demonstrated a 35% slowing of cognitive and functional decline compared to placebo at 18 months and a 39% reduction in the risk of disease progression [1].

The approval in Australia is particularly significant given the high prevalence of Alzheimer's disease in the country, with an estimated 600,000 Australians currently living with the condition. Approximately 450,000 of these individuals are in the early stages of the disease, making them eligible for treatment with Kisunla [1].

Kisunla is administered intravenously every four weeks and has shown efficacy in reducing amyloid plaque buildup and slowing cognitive decline. However, the therapy also carries the risk of serious side effects, including amyloid-related imaging abnormalities (ARIA) and infusion-related reactions. The product information includes a boxed warning about the potential for ARIA to mimic stroke symptoms [1].

The registration of Kisunla in Australia is based on the results of the TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6 clinical trials. Lilly continues to study donanemab in multiple clinical trials, including TRAILBLAZER-ALZ 3 and TRAILBLAZER-ALZ 5, focused on reducing the risk of progression to symptomatic Alzheimer's disease in preclinical patients and early symptomatic patients, respectively [1].

The approval of Kisunla in Australia follows its successful registration in several other countries, including the United States, Japan, China, the United Kingdom, and several Middle Eastern and Asian nations. This expansion of regulatory approvals underscores the potential of amyloid-targeting therapies in the treatment of Alzheimer's disease and highlights Lilly's commitment to advancing innovative solutions for this challenging condition [1].

References:
[1] https://www.prnewswire.com/news-releases/lillys-kisunla-donanemab-receives-marketing-authorization-in-australia-for-the-treatment-of-early-symptomatic-alzheimers-disease-302462448.html