Athena Gold Corp

Tau Inhibitors Clinical Trial Pipeline Analysis shows 25+ key companies expected to transform treatment, with increased funding accelerating advancements in neurodegenerative disease therapies.

Dr. Leen Kawas discusses biotech sustainability, emphasizing environmental impact reduction, regulatory compliance, long-term viability, and stakeholder expectations. She highlights strategies like sustainably sourced materials, green chemistry, environmentally friendly product design, waste minimization, and energy efficiency. Emerging trends include increased demand for sustainable products, green R&D investment, collaborations, and regulatory support. Challenges include high costs and balancing sustainability with product efficacy and compliance.

The global healthcare CRO market is projected to grow from USD 52.19 billion in 2023 to USD 104.60 billion by 2033. CROs offer services like drug discovery and clinical trials, benefiting biotechs with global research experience, trial site familiarity, and resource efficiency. However, potential downsides include insufficient resource allocation, staff turnover, and timeline adherence issues. Leen Kawas suggests CROs should focus on outcome-driven contracts and talent retention to better serve biotech sponsors.

Athira Pharma's experimental Alzheimer's drug fosgonimeton failed to show clinical benefit in a Phase 2/3 trial, despite targeting the HGF/MET pathway to protect brain cells. The placebo group did not experience cognitive decline, complicating the drug's efficacy assessment. The company did not announce further trials.

Fosgonimeton, an investigational medication from Athira Pharma, did not significantly improve cognitive and daily functioning in a Phase 2/3 trial for mild to moderate Alzheimer’s disease, despite being safe and well-tolerated. The trial’s primary endpoint, the Global Statistical Test (GST), showed a small difference favoring fosgonimeton over placebo, but not statistically significant. Fosgonimeton did show some numerical superiority in pre-specified groups, such as those with more advanced Alzheimer’s or the APOE4 gene variant. The treatment also resulted in a significant reduction in blood tau levels and other Alzheimer’s biomarkers, though not significantly. Fosgonimeton was generally well-tolerated, with more treatment-emergent side effects, mostly injection site reactions.

Eisai and Biogen's Leqembi and Eli Lilly's Kisunla are first anti-amyloid antibodies to slow Alzheimer's cognitive decline. 32 therapeutics in Phase III trials target neuroprotection, neurotransmitters, neurogenesis, inflammation, and proteinopathies. Leqembi and Kisunla have limited efficacy and notable side effects, prompting diverse opinions on clinical benefit. Next-gen therapeutics aim for easier administration and multiple pathways to treat Alzheimer's.

Athira Pharma's lead candidate, fosgonimeton, failed Phase II/III LIFT-AD trial for Alzheimer's, causing a 81% stock drop. Despite missing primary and secondary endpoints, Athira remains committed to fosgonimeton's development, citing potential benefits in specific subgroups. Full data will be presented at the CTAD Conference in Madrid.

Athira Pharma's Phase II/III LIFT-AD trial of fosgonimeton for Alzheimer's disease failed to meet primary and secondary endpoints, with the therapy showing no significant improvement over placebo. The company cited lack of decline in the placebo group and short study duration as possible reasons. Despite the setback, Athira remains optimistic about the potential of HGF pathway modulation for neuronal health improvement and disease mitigation, encouraged by biomarker and subgroup data.

The LIFT-AD trial showed fosgonimeton failed to meet its primary endpoint in mild-to-moderate Alzheimer's disease but had a numerically greater effect in APOE carriers. Fosgonimeton was generally well-tolerated with a favorable safety profile. Full data will be presented at the CTAD conference in Madrid.