7:30 am Check In & Light Breakfast
8:25 am Chair’s Opening Remarks
Navigating the Recently Reshaped MASH Landscape to Maximize Therapeutic Success
8:30 am Panel Discussion | Exploring the State of Play with Rezdiffra’s Approval
Synopsis
- Discussing the impact of Rezdiffra on the therapeutic treatment of MASH
- Assessing how clinical trials and other drug classes are affected
- How will the standard of care be impacted?
9:00 am Unlocking Madrigal’s Experience with Regulatory Challenges
Synopsis
- Leveraging learnings from Rezdiffra’s recent approval
- Exploring how no biopsy requirement was achieved
- Unearthing how their clinical trial and endpoints were defined
9:30 am Establishing Robust Clinical Trial Design to Overcome Past Failings
Synopsis
- Reducing screen failure rates through effective design
- Optimizing cirrhosis, MASH and fibrosis targeting in trials
- Regulatory pathways for cirrhosis
- Targeted endpoints for MASH and cirrhosis
10:00 am Speed Networking
Synopsis
A prime chance to make the most of the in-person networking with a niche community of MASH professionals working in space. Designed to maximize your introduction to numerous new individuals and serve as a catalyst for ongoing discussions during the summit.
10:45 am Morning Break
Track 1: Preclinical & Translational
Navigating the Fibrotic & Inflammatory Components of MASH to Achieve a Holistic Therapeutic
11:00 am The Free Choice Diet-Induced Obese MASH hamster: a translational drug efficacy model for human MASH and MetALD
Synopsis
- Utility and limits of the classical rodent MASH models
- Describing the free choice diet-induced obese MASH hamster as a new translational model
- How the hamster helps demonstrating therapies potential for patients with MASH and MetALD
11:10 am Making “Sense of the Mess”: How to Define and Drug Functional Subsets of Macrophage Contributing to Fibrosis Progression?
Synopsis
- With substantial advancements in the metabolic treatment of MASH how can fibrosis and inflammation be effectively combated?
- Overview of preclinical antifibrotic developments
- Delving into mechanistic insights and targeting of myosatellites
11:40 am Nonhuman primate obese models for preclinical pharmacology researches
Synopsis
- The features of our spontaneous and high fat diet induced obese monkey models
- The new biochemistry and imaging technologies developed for obesity model validation and treatment efficacy evaluations
- Efficacy studies with various kinds of testing substances on our obese monkey models
11:50 am Understanding the Role of Macrophages in the Progression of MASLD
Synopsis
- Exploring the subtypes of macrophages as MASLD progresses
- Investigating the functional relevance of the different subsets at different disease settings
Track 2: Clinical & Regulatory
Overcoming Screen Failures by Advancing MASH Trial Formatting
11:00 am Session Reserved for Summit Clinical Research
11:10 am Navigating the Sub Stratification of Cirrhotic Patients to Optimize in Clinical Trial Design
Synopsis
- Factoring the continuum state of cirrhosis into MASH clinical trial design
- Which pathways to target at different points of the continuum
11:40 am Biomarker driven patient selection using Almac PNPLA3 & HSD17B13 Clinical Trial Assays
Synopsis
- Overview of the PNPLA3 & HSD17B13 Almac Clinical Trial Assays
- Assay Design & Analytical Specifications
- Implementation of the PNPLA3 or HSD17B13 assay in your MASH / MAFLD trial & expected performance
11:50 am Conducting Cirrhotic & Non-Cirrhotic Trials in Parallel a Case Study
Synopsis
- Exploring approaches to operational synergies
- Detailing criteria for site selection
- Achieving regulatory synergies
12:20 pm Lunch
Track 1: Preclinical & Translational
Biomarkers, TBF- β Manipulation & Thyromimetic Drugs to Catalyze Preclinical Success
1:20 pm Deep Diving into Biomarker Results From a Phase 2 Study of the CC-90001 JNK Inhibitor in NASH with Advanced Fibrosis
Synopsis
- Exploring how biomarkers can inform on mechanisms of fibrosis
- Treatment of F3 NASH Subjects with the CC-90001 JNK inhibitor associated with dose-dependent reductions in multiple biomarkers of fibrosis, including ELF and PRO-C3
- Dose-dependent reductions in imaging MRE score were consistent with serum fibrosis biomarker results
- Effects of CC-90001 appeared to be mostly anti-fibrotic with little impact on imaging or biopsy measures of steatosis
1:50 pm Tackling Fibrosis Through TBF- β Manipulation
Synopsis
- Wound healing and fibrosis: Two sides of the coin
- Unearth molecular mechanism of TGF-β activation
- Dissect the cellular targets and downstream effects of TGF- β signaling
- Unlock TGF-β signaling dynamics and potential therapeutic target
2:20 pm Exploring Approaches to Deliver Thyromimetic Drugs for Obesity
Synopsis
- Weight loss with TRbeta agonist in DIO model
- Lowering of cardiovascular biomarkers
- Potential alternatives or combination approach with GLP1s
Track 2: Clinical & Regulatory
Leveraging GLP-1 Class for MASH Drug Development
1:20 pm Delving into the Application of the Obesity Drug Revolution for MASH:DD01 a Unique Dual Agonist that Rapidly Reduces Liver Fat’ after the word MASH
Synopsis
- DD01 is well tolerated at doses that rapidly reduce hepatic steatosis and improve glucose tolerance in obese diabetics with diabetes and MASLD
- Mechanistic studies in animals reveal DD01 is more effective than calorie restriction or treatment with a GLP-1 in reducing liver fat and reveal concurrent improvements in clinical markers of MASH resolution that are not matched by equivalent doses of semaglutide
- The unique therapeutic profile of DD01, a pegylated GLP1/Glucagon receptor agonist, show it provides rapid reductions in hepatic steatosis that are attributable to glucagon and can be uncoupled from the more gradual effects of calorie restriction and weight loss
1:50 pm Investigating Combinational Approaches to Elevate GLP-1 Therapies: Role of 2nd generation ASK1 inhibitor SRT-015 treatment for MASH fibrosis
Synopsis
- SRT-015 is an oral compound with direct pleotropic effects on the liver including fibrotic, inflammatory and apoptosis inhibition for possible use in all MASH fibrosis stages
- Combination therapy with GLP-1s and other metabolic agents
- In a phase 1 clinical trial, SRT-015 demonstrated pharmacokinetics that enables daily dosing with a favorable safety profile
2:20 pm Unlocking Glucagon Biology to Overcome Fibrosis in MASH
Synopsis
- Understanding the therapeutic benefit of glucagon-based agents on serum and hepatic lipids
- Navigating Pemvitutide Phase 2b trial data
- Analyzing the effect on inflammation, LDL cholesterol and body composition
2:50 pm Afternoon Break & Poster Session
Synopsis
Immerse yourself in an engaging and informal session, join your peers in a relaxed atmosphere that encourages meaningful conversions and relationship building. Explore a range of exciting poster presentations of the latest MASH strategies and showcase your own innovations in MASH drug development. Don’t miss out on the chance to connect, learn, and present.
Showcasing Future Consideration with Clinical Guidelines, Imaging & Surrogate Endpoints
3:30 pm Panel | Translating GLP-1s, Rezmiteron, FGF21 Therapies into Clinical Practice Guidelines in a Rapidly Changing Landscape
Synopsis
- Assessing how current therapies fit into the standard of care
- Navigating the future of combination therapies to optimize treatment
- Evaluating how this will play out in the real world with access, non-responders, standard of care and the shift to primary care providers