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Investor Presentaiton

R&D investor presentation 20 Semaglutide showed encouraging phase 2 data across additional important endpoints which are considered relevant by regulators Regulatory guidelines on non-invasive endpoints FDA Non-invasive, disease-specific biomarkers, and imaging modalities that assess liver stiffness or hepatic fat content are acceptable as POC study endpoints as long as the sponsor can scientifically justify them¹ Mean change in ELF from baseline at 72 weeks Relative mean change in liver stiffness³ at 72 weeks 1.0 1 0.9 0.0 -0.02 -0.1 -0.2 -0.3 * -0.4 -0.35 -0.5 * -0.44 0.8 0.7 0.75* 0.69* 0.68* -0.6 -0.7 0.6 * -0.64 -0.8 0.5 Placebo 0.1mg 0.2mg 0.4mg Placebo 0.1mg 0.2mg 0.4mg Semaglutide once-daily Semaglutide once-daily EUROPEAN MEDICINES AGENCY SCIENCE MEDICINES HEALTH Due to the slow development of fibrotic stages and the low prevalence of the disease, the difficulties for the validation of the proposed intermediate endpoints are acknowledged. Future applicants should therefore also take care that a sufficient amount of supportive evidence for long-term efficacy is available. This should consist of standard evaluations such as imaging modalities, other biomarkers (bilirubin, transaminases, but also e.g. ELF-test and other potential future biomarkers)² * statistically significant at 72 weeks (p<0.05 vs placebo). Based on the on-treatment analysis using mixed-effect model repeated measure (MMRM) 1 FDA guidance on developing treatment for NASH: "Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment Guidance for Industry", link 2 EMA guidance on developing treatment for NASH: "Reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH)" 3 % of baseline POC: proof of concept; ELF: enhanced liver fibrosis
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