NewAmsterdam Pharma Company (NAMS) Update / Briefing Transcript

Summary of New Amsterdam Pharma Company (NAMS) Conference Call - July 30, 2025 Company Overview - Company: New Amsterdam Pharma Company (NAMS) - Focus: Development of obacetropib for Alzheimer's disease and its potential as a disease-modifying therapy Key Industry Insights - Alzheimer's Disease: The conference highlighted the significance of obacetropib in potentially slowing or preventing Alzheimer's disease progression, particularly in APOE4 carriers, a high-risk genetic group for both Alzheimer's and cardiovascular diseases [6][7][9] - Biomarkers: The presentation emphasized the importance of pTau217 as a biomarker for Alzheimer's disease progression, showing that obacetropib significantly reduced pTau217 levels compared to placebo [12][13][14][18] Core Findings and Data - Clinical Trial Results: - In the Broadway trial, obacetropib resulted in a statistically significant reduction in pTau217 progression over 12 months, with a 1.99% increase in the treatment group versus nearly 5% in the placebo group (p=0.019) [12] - In APOE4 carriers, the increase was 1.45% with obacetropib compared to 7.19% with placebo (p=0.022) [12] - In APOE4 homozygotes, a 20.5% absolute difference in pTau217 progression was observed (p=0.01) [13] - Comprehensive Biomarker Improvement: The trial showed favorable trends across multiple Alzheimer's biomarkers, including GFAP and neurofilament light (NfL), indicating a potential for disease modification [15][22][24] Potential Market Impact - Differentiation from Existing Therapies: Obacetropib is positioned as a first-in-class oral therapy that not only lowers LDL cholesterol but also addresses Alzheimer's pathology, which is not achieved by current anti-amyloid therapies [22][25] - Target Population: Approximately 25% of the general population are APOE4 carriers, representing a significant market opportunity for obacetropib as a preventive treatment [23][36] Regulatory and Development Considerations - Future Studies: The company plans to engage with the FDA regarding the potential for obacetropib to be used in primary prevention of Alzheimer's disease, with ongoing trials like PREVAIL involving 9,500 patients [54][59] - Biomarker as Endpoint: There is ongoing discussion about the potential for pTau217 to be accepted as a registrational endpoint, although current FDA stance may require cognitive outcome data [63][70] Expert Panel Insights - Panelists' Perspectives: Experts highlighted the significance of the findings, particularly the safety profile of obacetropib and its potential for early intervention in high-risk populations [26][31][41] - Preventive Neurology: The need for a precision medicine approach in Alzheimer's treatment was emphasized, advocating for the use of biomarkers to personalize care [34][38] Conclusion - Strategic Positioning: New Amsterdam Pharma is positioned to lead in the development of innovative therapies for Alzheimer's disease, with obacetropib showing promise as a unique oral treatment that addresses both cardiovascular and neurodegenerative risks [22][25][54]