Pre-Conference Seminar Day
Monday, November 27 2023

Seminar A: Novel Targets

Entering a New Era: Discovering New Targets with Potential to Alter Disease Evolution
Seminar Moderator:

  • Mark Hartman Vice President, Medical, NASH/Obesity, Eli Lilly & Co.

9:25 am Chair’s Opening Remarks

  • Mark Hartman Vice President, Medical, NASH/Obesity, Eli Lilly & Co.

9:30 am The Power of Three G’s: Retatrutide Phase 2 Results in Participants with T2DM, Obesity & NAFLD

  • Mark Hartman Vice President, Medical, NASH/Obesity, Eli Lilly & Co.

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:

  • Gregory Everson Founder & Chief Executive Officer, HepQuant
  • Erik Tillman Associate Director - Translational Biology & Pharmacology, Akero Therapeutics

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

  • Erik Tillman Associate Director - Translational Biology & Pharmacology, Akero Therapeutics

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

  • Kavita Juneja Senior Director, Head of Metabolic Therapeutic Development, Corcept Therepeutics

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

  • Tien Lee Chief Executive Officer, Aardvark Therapeutics

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

  • Mark Hartman Vice President, Medical, NASH/Obesity, Eli Lilly & Co.

1:00 pm New Metabolic Target & Metabolic Marker Suggest a Way Forward in Metabolic Associated Steatotic Liver Disease (MASLD)

  • Jerry Colca Chief Scientific Officer, Cirius Therapeutics

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

  • Wladislaw Malkov Head of Clinical Bioinformatics, Data Sciences, Inflammation & Therapeutics Area, Gilead Sciences

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

2:30 pm Chair’s Closing Remarks

  • Erik Tillman Associate Director - Translational Biology & Pharmacology, Akero Therapeutics
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