ASN-51
- Generic Name
- ASN-51
European Regulators Reject Eli Lilly's Alzheimer's Drug Kisunla Over Safety Concerns
• 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.
Asceneuron Discontinues Phase I Alzheimer's Trial of Tau-Targeting Drug ASN90
• Asceneuron has halted its Phase I clinical trial of ASN90, a novel tau-targeting compound for Alzheimer's disease, adding to the growing list of setbacks in tau-based therapeutic approaches.
• The decision to discontinue the trial reflects the ongoing challenges in developing effective treatments targeting tau protein aggregation, a key pathological hallmark of Alzheimer's disease.
• This development impacts the broader landscape of Alzheimer's drug development, where tau-targeting approaches have faced significant hurdles despite their theoretical promise.
Alzheimer's Disease Pipeline Shows Promise with 120+ Therapies in Development
• 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.
Eli Lilly's Ceperognastat Fails to Meet Cognitive Endpoints in Phase 2 Alzheimer's Trial
• Eli Lilly's ceperognastat, an O-GlcNAcase inhibitor, slowed brain atrophy and tau accumulation in a Phase 2 trial for early symptomatic Alzheimer's disease.
• Despite positive biomarker effects, the high-dose group of ceperognastat showed significantly faster cognitive decline compared to the placebo group.
• Adverse events, including cardiac and nervous system disorders, were more prevalent in the ceperognastat treatment groups, raising concerns about off-target effects.
• While Lilly is monitoring extended safety data, future studies with ceperognastat are uncertain, prompting a reevaluation of small molecule approaches targeting tau modification.
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