8:25 am Chair’s Opening Remarks
Selecting Efficacy Endpoints to Establish Clinical Validity with NASH Resolution, Fibrosis Improvement & in Combination Therapy
8:30 am Breakthrough for NASH Drug Development Needs Combination Therapy & Reliable Composite Surrogate Endpoint
Synopsis
- Delving into NASH prevalence and the market size
- Elucidating the ways to tackle the challenges in developing an effective NASH drug
- Key regulatory considerations for combination therapy and navigating regulatory approval pathways
9:00 am Hepatic & Cardiometabolic Endpoints Demonstrate Efficacy of Lanifibranor Across the Spectrum of NASH Biology
Synopsis
- Delving into the late-stage development of lanifibranor; a balanced α, β/δ and γ agonist, for the treatment of NASH
- Demonstrating efficacy on histological NASH resolution and improvement of fibrosis, cardiometabolic health, lipid and glucose metabolism, insulin resistance and systemic inflammation in the Phase 2b NATIVE study
- Correlating adiponectin, a downstream mediator of lanifibranor signaling with the broad efficacy of lanifibranor on markers of cardiometabolic health
9:30 am Underneath the Lost Kilos: Imaging the Effects of Weight Loss in Clinical Trials
Synopsis
- The importance of understanding weight loss of novel anti-obesity drugs and the differentiated effects of different drug mechanisms
- How imaging can be used in drug development to further the understanding of where the weight is actually lost using body and muscle composition as well as looking at other ectopic fat depots
- Imaging can be used to investigate the effects of weight loss on downstream organs and disease states including the liver, kidney, and heart
10:00 am Panel Discussion: Harmonizing Global Regulations to Drive Progress in Therapeutic Development
Synopsis
- Considering market access in the context of distinct payer metrics and regulatory expectations
- From the FDA to the EMA: what are the differences?
- How to approach global regulatory agencies
10:30 am Morning Break & Networking
Track A: Preclinical & Translational Track
Exploring the Full Potential Multi-Omics Analyses Hold as Discovery & Analytical Tools & Improve the Translational Development Landscape
Track Moderator:
Track Moderator:
11:00 am Reversing Liver Fibrosis: A Combination of Anti-NASH siRNA & Semaglutide
Synopsis
- Identifying genomic variants from a large group of patients to derive robust targets
- Delving into the effects of weight loss to due to energy expenditure compared to incretin-based drugs
- Disentangling the forthcoming combination studies to increase the efficacy of reversing liver fibrosis and inducing reduction of liver fat content
11:30 am Nonhuman Primate Obese & NASH Models for Preclinical Studies
Synopsis
- Spontaneous and high fat diet induced NHP obese models are available for biological compound and gene therapies
- NHP NASH model with very close similarity to human NASH is ideal for efficacy assessment
- New MRI techniques are used for validation and efficacy
11:40 am Highlighting a First-in-Class Leptin Sensitizer for the Treatment of Obesity
Synopsis
- Unveiling a different mechanism of action in comparison to the currently existing molecules in the marketplace
- What is the clinical experience research so far?
- Translating basic research and preclinical data into clinical findings
Track B: Clinical, Regulatory & Outcomes Track
Consolidating Digital Pathology to Standardize Biopsy Assessments & Innovating Clinical Trial Design to Optimize Study Outcome
11:00 am Using AI/ML & Multi-Omics to Determine Efficacy for Clinical NASH Study Enrichment: Highlights from Recently Completed Phase 2 Trials with Rencofilstat
Synopsis
- Use of AI/ML to enrich NASH clinical trials
- Use of Multi-omics with ML for biomarker prediction
- Use of AI/ML for NASH patient selection
11:40 am Assessing Current Scoring Systems in Identifying Fibrosis Regression & Their Limitations
Synopsis
- Pairing novel microscopy methods with artificial intelligence to standardize the evaluation of NASH features
- Better quantifying liver fibrosis and collagen fibre on a continuous scale
- Using clustering algorithms to identify sources of variation in a meta-analysis of control
12:10 pm Lunch Break & Networking
1:10 pm Detailing Scar-Associated Macrophages in Preclinical Models & Patients for Liver Fibrosis Drug Development
Synopsis
- Exploring single cell transcriptomic characterisation of pathogenic macrophages in liver fibrosis and NASH
- Validation and mechanistic exploration in mouse models
- Supporting future drug discovery development with translational human cell systems
1:40 pm Unravelling a Liver-Adipose Feedback Loop Involving Hepatic Activin E to Elucidate Novel Therapeutic Opportunities to Regulate Body Fat Distribution
Synopsis
- Activin E mediates liver-adipose inter-organ communication, suppressing adipose lipolysis to regulate hepatic triglyceride
- Identifying the role of the ALK7/Activin E signaling axis in the regulation of body fat distribution
- Detailing how disruption of the Activin E/ALK7 inter-organ communication loop in mice leads to insulin resistance and hepatic steatosis
2:10 pm Chair’s Closing Remarks
1:10 pm Holistic Approaches to Metabolic Syndrome: Navigating Comorbidities, Interactions & Treatment
Synopsis
- Chronic kidney disease, cardiovascular disease, and diabetes: what associated outcomes can you demonstrate in a clinical trial?
- Considering impact of new therapies on comorbidities
- Holistic approaches to drug development: how interlinked is pathogenesis and treatment in metabolic syndrome?
1:40 pm Employing Human Genetics to Enable the Discovery of CIDEB as a Novel Therapeutic for NAFLD in Humans
Synopsis
- Demonstrating the value of human genetics in enhancing therapeutic development
- Utilising different types of genetic analyses in target discovery
- Discovery of CIDEB as a novel gene that influences NAFLD in humans and development of CIDEB therapeutics