Seminar A: Novel Targets
Entering a New Era: Discovering New Targets with Potential to Alter Disease Evolution
Seminar Moderator:
Seminar Moderator:
9:25 am Chair’s Opening Remarks
9:30 am The Power of Three G’s: Retatrutide Phase 2 Results in Participants with T2DM, Obesity & NAFLD
Synopsis
- Delving into Retatrutide (LY3437943): a triple agonist of the GIP, GLP-1 and glucagon receptors to better understand its mechanism of action
- Showing clinically meaningful improvements in glycemic control and robust reductions in body weight in a Phase 2 study in participants with T2DM
- Demonstrating substantial reductions in body weight in a Phase 2 study in participants with obesity or overweight with ≥1 weight-related condition and significant reductions in liver fat in a substudy in participants with NAFLD
10:00 am How to Supplement Metabolic Treatment Regiment with Anti-Fibrotic Agents
Synopsis
- Achieving accelerated fibrosis regression by moving beyond just weight loss
- Studying fibrosis resolution mechanisms
- Delving into the combination between metabolic agents with more specific aspects of the scar tissue
10:30 am Morning Break and Networking
11:00 am Active Cellular Targeting miRNA Oligonucleotide Therapeutics (ONTs) to Treat Metabolic Pandemics
Synopsis
- Discovery and validation of miR-22-3p as an excellent metabolic miRNA
- In silico, in vitro and in vivo validation of miR-22-3p antagomirs to treat obesity, MAFLD and related cardiometabolic disorders
- Current preclinical validation of Generation 2.5 miR-22-3p antagomirs for enhanced active targeted delivery of a greatly reduced therapeutic dose with an extended intracellular Mean Residence Time
11:30 am Unlocking Powerful Biology: OGB21502 is a Tetra- Specific Drug (GLP-1 X GCG X FGF21 X IL1RA) to Treat NASH & Liver Fibrosis
Synopsis
- Novel protein-protein conjugation technology, which enables the facile development of multi-modalities, multi-targeting drugs
- Can IL-1 blocking make synergy in improving fibrosis and metabolism?
- Preclinical findings recommend transitioning towards the clinical stage in 2024
Seminar B: Non-Invasive Biomarkers
Reimagining Non-Invasive Biomarkers for Improved Clinical Outcome to Move the Needle on Validation
Seminar Moderators:
Seminar Moderators:
9:25 am Chair’s Opening Remarks
9:30 am Improvements in Non-Invasive Biomarkers & Their Correlation to Histology: Significance of Eliminating the Disease Driver in Achieving a Sustained Benefit
Synopsis
- Discuss the importance of consistency of effect across the different markers of NASH pathophysiology including liver fat, liver injury and fibrosis
- Discuss the normalization of non-invasive parameters with EFX and correlation with histologic improvement
- Significance of eliminating underlying disease drivers to achieve a sustained response
10:00 am Uncovering the Successes in Reducing Fatty Liver by Leveraging MRI-PDFF
Synopsis
- Illuminating the impacts of NASH in type 2 diabetes
- What are the advantages of MRI versus biopsy?
- Revealing the latest positive results in clinical study to successfully move away from biopsies
10:30 am Morning Break and Networking
11:00 am Next Generation Liver Function Testing for Drug Development and the Clinic
Synopsis
- Utility in clinical trials
- Improvements in test administration
- Relationship to outcomes
11:30 am Updates from NIMBLE: Deep Diving into the Current Non-Invasive Technologies for NASH
Synopsis
- Elucidating the current unmet need to decrease the rate of biopsies
- Navigating the route towards leveraging non-invasive biomarkers and how diagnostics could increase participation in drug trials
- Uncovering updates from NIMBLE and plans for future clinical trials
12:00 pm Lunch Break & Networking
1:00 pm Investigating Miricorilant, a Selective Glucocorticoid Receptor Modulator, for Treatment of NASH
Synopsis
- Developing miricorilant, a selective glucocorticoid receptor modulator, as a novel treatment for NASH
- Review efficacy of miricorilant in preclinical models of fatty liver disease and early clinical trials in patients with presumed NASH
- Next steps: Phase 2 development program for treatment of patients with non-cirrhotic NASH
1:30 pm Losing Fat Mass Without Impacting Muscle Mass: A New Approach for Weight Loss
Synopsis
- Directly targeting fat mass without impacting food intake
- Discovering a novel target for impacting obesity and obesity linked diseases
- Unravelling a new class of molecules for metabolic diseases
2:00 pm Hunger Vs Appetite: A New Paradigm for Framing Obesity Management
Synopsis
- Delving into the importance of CCK and its relation to hunger specifically
- Engaging the gut brain axis and explaining how hunger and appetite would be complimentary to each other in approach
- Demonstrating statistically significant hunger score reduction for HQCT and ghrelin to illustrate additional benefits unknown to GLP-1 RAs
2:30 pm Chair’s Closing Remarks
1:00 pm New Metabolic Target & Metabolic Marker Suggest a Way Forward in Metabolic Associated Steatotic Liver Disease (MASLD)
Synopsis
- New view of the pathophysiology of MASLD/MASH: further examing Phase 2b data for an insulin sensitizer with a newly appreciated mitochondrial target
- Fasting hyperinsulinemia as an addressable marker for reduced liver function leading to disease progression
- Exploring metabolic reprogramming in multiple cell types to address multi-organ involvement in the pathology
1:30 pm Exploring the Utilization of Effective Combination Therapy with the Right Diagnostic Tool to Optimize the Management of the NASH Population
Synopsis
- Outlining the steps needed to ensure the management of patients is improved following drug approval
- Understanding how combination therapy could affect real world settings to prevent rebounds
- Strengthening the synergy between pharma and biotech to increase investments and awareness of the management journey for patients
2:00 pm Panel Discussion: Deliberating the Next Steps Towards the Identification & Application of Non-Invasive Biomarkers for NASH
Synopsis
- Discussing appropriate biomarkers for patients’ segmentation and better understanding heterogeneity
- Maximizing treatment responsiveness by leveraging predictive biomarkers (responder vs non-responder)
- Efforts on linking NITs to clinical outcome/benefits