7:50 am Check In & Registration
8:20 am Chair’s Opening Remarks
Reverse Translation: Taking Insights from Phase 2 Studies from Bedside to Bench to Refine Preclinical Strategy, Build the Right Body of Evidence & Accelerate Antifibrotic Innovation
8:30 am Development and Approval of Resmetirom for Treatment of Patients with MASH with Moderate to Advanced Liver Fibrosis
Synopsis
- Understanding the development of Resmetirom based on serial liver biopsy testing to provide unambiguous histopathological evidence and rigorously assess fibrosis regression and MASH resolution to accelerate FDA approval
- Diagnosing and monitoring patients using non-invasive tests to stratify patients and monitor treatment response, to differentiate between cirrhotic from non-cirrhotic MASH, empowering clinicians to identify high-risk patients earlier and tailor therapies, boosting real-world adoption
9:00 am Translating GRI 0621 from Preclinical Models to Phase 2a IPF Signals
Synopsis
- Highlight the impact of GRI 0621 in resolving inflammation and fibrosis in preclinical bleomycin-induced models and how this informed clinical design
- Review preliminary Phase 2a results in IPF patients and discuss implications for dose, patient selection, and endpoint refinement
- Explore how early clinical insights are feeding back into preclinical strategy to sharpen target validation and accelerate development
- Consider how Phase 2a signals are being evaluated to de-risk and prepare for a potential Phase 2b/3 transition strategy
9:30 am Translating RXC007 preclinical antifibrotic efficacy to Ph2a PoC in IPF
Synopsis
- Summarising RXC007 in vivo antifibrotic activity across preclinical rodent fibrosis models
- Presentation of RXC007 Ph2a anti-fibrotic signals in Ph2a IPF trial
- Exploratory circulating biomarkers in IPF and presentation of RXC007 changes
10:00 am Panel Discussion: How Early Clinical Learnings Can Inform Smarter Preclinical Strategy for Antifibrotic Drug Development
Synopsis
As more antifibrotics enter early-phase clinical trials, translating bedside learnings back into the lab has never been more important. This panel gathers experts in early clinical development to examine how clinical signals, can be mined to refine target selection, guide biomarker validation, and improve preclinical model design.
- How Phase 2 outcomes including responder subtypes are informing updates to preclinical models for improved translational relevance to refine preclinical models with clinical feedback
- Uncover strategies across disease areas to incorporate biomarkers, imaging, and functional readouts into preclinical studies that mirror clinical endpoints and support future regulatory alignment to embed clinically meaningful endpoints earlier
- Exploring how best to apply Phase 2 learnings to strengthen preclinical data packages, optimizing dosing, toxicology thresholds, and study design to de-risk early development for smarter IND enabling packages
- Using insights from heterogenous patient responses to refine hypotheses, select more predictive models, and prioritize mechanisms likely to succeed in defined populations
10:30 am Morning Break
Alternative Delivery Methods & Approaches with Increased Selectivity & Specificity
11:00 am A Capsid Virus-like Particle Based Vaccine Displaying IL-11 for Treatment of Fibrotic Diseases
Synopsis
- Leveraging AdaptVac’s virus-like particles-based vaccine platform with proven safety in clinical trials, to display self-antigens for the induction of autoreactive antibodies for the treatment of chronic diseases.
- Showing proof of mechanism for an IL11 targeting vaccine in overcoming immune tolerance in mice and guinea pigs
- Demonstrating proof of concept in a MASH guinea pig model, validating translational relevance for targeting IL11 in MASH patients and positioning cVLP-IL-11 as a firstin- class immunotherapy for metabolic fibrosis.
11:30 am Translating 3D Liver Fibrosis Models into Clinically Relevant Antifibrotic Drug Discovery
Synopsis
- Exploring the benefits of advanced invitro 3D Models for antifibrotic development and prioritization of targets with higher translational potential
- Analysing the antifibrotic effects of VIS08 in animal and in vitro 3D models uncovering novel mechanisms beyond canonical pathways
- Understanding the advantages of novel 3D models beyond MASH in DILI for improved efficacy testing of liver toxicity
12:00 pm Lunch Break
1:00 pm Antibody-Drug Conjugates as Antifibrotic: Depleting Disease-Driving Cells
Synopsis
- Explore the use of single cell and spatial transcriptomics to identify pathogenic fibroblasts.
- Discuss the development of ADCs that selectively target pathogenic fibroblast populations driving fibrosis across organs
- Evaluate the translational potential of fibroblast-depleting ADCs across fibrotic diseases through various preclinical models.
1:30 pm Using Antibody-Drug Conjugates to Selectively Inhibit Disease-Driving TGF-β Isoforms & Cells
Synopsis
- Introduce a novel therapeutic approach to target the TGF-β pathway, a key driver of fibrosis, while improving efficacy, safety, and patient outcomes through selective inhibition
- Discuss the design and development of cell-targeted ADCs that inhibit TGF-β in pathogenic cell populations, enhancing on-target specificity and minimizing off-target effects compared to systemic therapies
- Explore the utility of ADC-based strategies for organ-specific fibrotic diseases, leveraging fibrosis-associated surface markers to guide targeted delivery and broaden therapeutic potential
2:00 pm Afternoon Break
Exploring the Future of Antifibrotic Research & Development
3:00 pm Panel & Audience Discussion: What’s Next for Fibrosis? Understanding the Future Directions of the Antifibrotic Field
Synopsis
This panel brings together experts from across various disease indications to explore the evolving scientific, translational, and clinical landscape of antifibrotic drug development to provide forward-looking perspective on where antifibrotic science is heading, which challenges are most urgent to overcome, and how industry and academia can collaborate more effectively to accelerate progress across diverse indication.
Discussion Topics Include:
- Emerging Key scientific breakthroughs and novel therapeutic targets shaping the future of antifibrotic drug development across multiple organ systems.
- Identify the key translational and clinical challenges hindering progress, including biomarker validation, patient stratification, and trial design optimization
- How emerging antifibrotic therapies can be integrated into existing treatment paradigms and the potential for combination strategies to improve patient outcomes