Non - Invasive Tests (NITs)
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Altimmune (NasdaqGM:ALT) Conference Transcript
2025-10-21 12:02
Summary of the Conference Call on Altimmune and Pemvidutide Company Overview - **Company**: Altimmune - **Product**: Pemvidutide - **Focus**: Clinical-stage biotechnology company developing treatments for metabolic dysfunction-associated steatohepatitis (MASH) Key Industry Insights - **Event**: HC Wainwright Virtual Liver Disease Conference - **Context**: The conference combined discussions on viral hepatitis, MASH, and liver cancer, highlighting the growing interest in liver disease therapeutics Core Points and Arguments 1. **Pemvidutide Mechanism**: Pemvidutide is a dual GLP-1/glucagon receptor agonist, designed to treat multiple components of MASH through direct liver effects and metabolic benefits [2][3] 2. **Clinical Data**: The 24-week study showed class-leading MASH resolution of approximately 59% of patients, with expectations for even better results at the upcoming 48-week data readout [5][8] 3. **Weight Loss and Liver Fat**: At the 1.8 mg dose, patients experienced over 6% weight loss, with about 50% normalizing liver fat [6][8] 4. **Tolerability Profile**: Pemvidutide demonstrated the lowest rates of adverse event discontinuations among incretins, with only 1% overall discontinuation due to adverse events [16][17] 5. **Regulatory Strategy**: The company is preparing for an end of phase 2 meeting with the FDA, focusing on the design of the phase 3 program and the potential use of non-invasive tests (NITs) as surrogates for biopsies [13][15] 6. **Market Opportunity**: MASH represents a significant commercial opportunity, targeting patients across various fibrosis stages (F2 to F4) [22][23] 7. **Competitive Positioning**: Altimmune believes that pemvidutide's dual mechanism provides a unique advantage over other therapies that typically focus on either metabolic or liver effects [20][25] Additional Important Insights - **Upcoming Milestones**: The company anticipates presenting 48-week data and having an end of phase 2 meeting with the FDA in the fourth quarter, which are critical for advancing to phase 3 trials [26] - **Combination Therapies**: There is a trend in the industry towards combination therapies for MASH, and pemvidutide's ability to address both liver and metabolic issues in a single molecule positions it favorably [24][25] - **Investor Sentiment**: The management team expressed confidence in pemvidutide's differentiation and readiness for phase 3, emphasizing the importance of upcoming data and regulatory discussions for investor interest [26] This summary encapsulates the key points discussed during the conference call, focusing on Altimmune's pemvidutide and its implications for the MASH treatment landscape.