Alzheon, Inc. | MedPath

Alzheon's Valiltramiprosate Shows Promising Results for Early-Stage Alzheimer's in APOE4 Homozygotes

2 months ago

• Phase 3 APOLLOE4 trial results reveal valiltramiprosate (ALZ-801) demonstrated significant benefits in patients with mild cognitive impairment, showing 52% improvement on ADAS-Cog13 and 102% improvement on CDR-SB scales. • Unlike anti-amyloid monoclonal antibodies, valiltramiprosate showed no increased risk of ARIA compared to placebo, potentially offering a safer treatment option for APOE4 homozygotes who are typically excluded from other therapies. • The oral administration of valiltramiprosate provides a competitive advantage over injectable monoclonal antibodies, with GlobalData forecasting potential US sales of $663.3 million in the MCI population by 2033.

European Regulators Reject Eli Lilly's Alzheimer's Drug Kisunla Over Safety Concerns

2 months ago

• The European Medicines Agency's advisory committee has recommended against approving Eli Lilly's Alzheimer's treatment Kisunla, citing safety concerns related to brain swelling. • European regulators determined that the risks of amyloid-related imaging abnormalities (ARIA) outweigh the potential benefits of the drug, creating a notable divergence from US regulatory decisions. • This rejection marks another instance where European and American regulators have reached different conclusions on new Alzheimer's treatments, highlighting regional differences in benefit-risk assessment.

Alzheon to Present Phase 3 Data for ALZ-801, Aiming to Slow Alzheimer's Progression

4 months ago

• Alzheon is set to present Phase 3 trial data for ALZ-801 in April 2025, a drug designed to prevent the formation of toxic beta-amyloid plaques in early Alzheimer's patients with the ApoE4 gene. • Anavex Life Sciences has submitted blarcamesine for approval in Europe after completing Phase 2/3 trials, though its efficacy has faced criticism and legal challenges. • Athira Pharma discontinued fosgonimeton development after failing to demonstrate clinical benefit and settled with the DOJ over data manipulation allegations. • Eisai and Biogen's Leqembi may become more accessible with an injectable version under FDA review, potentially allowing for at-home administration.

Alzheimer's Disease Market Set to Surge to $19.3B by 2033, Driven by Novel Therapies

4 months ago

• The global Alzheimer's disease market is projected to grow at a CAGR of 23.4%, expanding from $2.4B in 2023 to $19.3B by 2033 across eight major markets. • Disease-modifying therapies, particularly amyloid beta-targeting drugs like Leqembi and Kisunla, are expected to dominate the market, contributing 73.5% of total market share by 2033. • Despite market growth, significant challenges remain, including treatment access barriers, need for improved diagnostics, and demand for more effective therapies targeting late-stage disease symptoms.

Alzheon's ALZ-801 Shows Promise in Reducing Phosphorylated Tau and Enhancing Memory in Early Alzheimer's Disease

5 months ago

• Alzheon's ALZ-801 demonstrated a 29% reduction in plasma p-tau181 levels at 26 weeks in patients with early Alzheimer's, indicating a potential disease-modifying effect. • Patients treated with ALZ-801 showed cognitive gains from baseline in memory tests, suggesting improvement rather than just slowing cognitive decline. • The oral agent ALZ-801 exhibited a good safety profile, with no vasogenic edema or drug-related adverse events reported, supporting its tolerability. • A Phase 3 study of ALZ-801 is ongoing in APOE4/4 early AD patients, assessing efficacy, safety, and biomarker effects over a 78-week period.

Alzheimer's Disease Pipeline Shows Promise with 120+ Therapies in Development

6 months ago

• Over 120 Alzheimer's Disease treatment therapies are under development by 110+ companies globally, ranging from preclinical to marketed phases. • Emerging therapies like NRDN-201, ST-501, and KarXT are in various clinical trial phases, showing potential for significant market impact. • MapLight Therapeutics initiated a Phase 1 trial for ML-007/PAC, targeting schizophrenia and Alzheimer's disease psychosis, with Phase 2 trials planned. • The FDA granted conventional approval to Leqembi (lecanemab-irmb), marking the first amyloid beta-directed antibody to transition from accelerated approval.

Ziftomenib Shows Promise in AML: Kura Oncology and Kyowa Kirin Advance to Phase 3 Trials

6 months ago

• Kura Oncology and Kyowa Kirin's ziftomenib demonstrates statistically significant efficacy in Phase 2 trial for relapsed/refractory NPM1-mutant acute myeloid leukemia (AML). • The companies plan to submit a New Drug Application (NDA) to the FDA in the second quarter of 2025, seeking approval for ziftomenib in R/R NPM1-m AML. • Phase 3 trials are set to begin in the second half of 2025, evaluating ziftomenib in combination with intensive and non-intensive chemotherapy regimens for newly diagnosed AML. • FDA feedback supports potential accelerated approval pathways in both intensive and non-intensive treatment settings, based on MRD negative CR and CR endpoints.

FDA Approves Lilly's Kisunla (donanemab-azbt) for Early Symptomatic Alzheimer's Disease

a year ago

• The FDA has approved Kisunla (donanemab-azbt) for treating early symptomatic Alzheimer's disease, including mild cognitive impairment and mild dementia stages. • Kisunla is the first amyloid plaque-targeting therapy allowing treatment cessation upon plaque removal, potentially reducing costs and infusion frequency. • Clinical trials showed Kisunla significantly slowed cognitive decline by 35% in early-stage patients and reduced amyloid plaques by up to 84% over 18 months. • Treatment with Kisunla carries potential side effects, including amyloid-related imaging abnormalities (ARIA) and infusion-related reactions, requiring careful monitoring.