Conference Day Two
Thursday, November 14 2024
8:00 am Check In, Morning Coffee & Light Breakfast
8:50 am Chair’s Opening Remarks
The Cutting Edge from the Clinic: New Standards in Disease Management on the Horizon
9:00 am Efficacy & Safety of Amlitelimab (An Anti-OX40 Ligand Antibody) in Patients with Moderate-to-Severe Atopic Dermatitis: A Phase 2b Trial (STREAM-AD)
Synopsis
- Amlitelimab is a fully human, nondepleting anti-OX40 Ligand (OX40L) monoclonal antibody that blocks OX40L-OX40 interactions upstream of T-cell expansion and inflammatory cytokine production
- STREAM-AD (NCT05131477), a randomized, double-blind, placebo-controlled Phase 2b trial, included a 24-wk treatment period (Part 1), a 28-wk maintenance/withdrawal period (Part 2), and a 16-wk safety follow-up
- All four doses of amlitelimab demonstrated statistically significant improvements in percent change in EASI from baseline to Wk16 vs placebo. Clinically meaningful improvements in key secondary endpoints were observed at Wk16, with continued improvements through Wk24. In Part 2, maintenance of EASI-75 and/or IGA 0/1 response at Wk52 was observed in the majority of clinical responders withdrawn from amlitelimab demonstrating a durable off-drug response
9:30 am Intentional & Tailored Design of Topical Therapy for Inflammatory Skin Diseases
Synopsis
- Appropriate target identification can facilitate clinically meaningful efficacy and a suitable MoA for dermatologic treatment
- Clinical expertise can inform optimal vehicle development most suited to patients’ needs
- Thoughtful development strategy can reflect the goal of long-term disease control in patients with chronic inflammatory skin disease
10:00 am Morning Networking Break
Synopsis
An opportunity to network, discuss and collaborate with like-minded leaders.
Discovery & Translation to the Clinic
Track Chair:
Bridging the Gap: Translating Candidates to the Clinic for Chronic Disease
11:00 am Panel Discussion: Personalized Medicine’s Place in Dermatology Drug Discovery
Synopsis
- How can advancements in molecular profiling and biomarker identification facilitate the implementation of personalized medicine approaches in dermatological drug development?
- What challenges exist in translating personalized medicine concepts, such as pharmacogenomics and patient stratification, into actionable strategies for dermatology drug discovery?
- As a more personalized medicine approach narrows addressable patient population size, what do commercial viability evaluations show, and what are the anticipations for its future place in the dermatology drug development field?
11:30 am Revolutionizing the Treatment of Skin-Related Inflammatory Conditions with Peptide-Based, Next- Generation Approach
Synopsis
- Preclinical efficacy of anti-inflammatory peptide in human inflammatory disease skin biopsies
- Demonstrating efficacy beyond comparative topical steroids
- An innovative approach to treat atopic dermatitis (AD, eczema), prevent its recurrence and possibly delay aging of the skin through a novel, next-generation anti-inflammatory, allosterically binding MAP kinase-inhibiting mechanism
12:00 pm Advancing Drug Development in Hidradenitis Suppurativa (HS) Through Translational Research & Biomarker Science: Providing New Clarity to Disease State & Treatment Response
Synopsis
- HS is a highly inflammatory condition characterized by deep dermal lesions — notably draining tunnels — that are the predominant sources of inflammation, with disease activity also reflected in elevated levels of systemic inflammation
- Many aspects of HS pathogenesis remain poorly understood, posing a barrier to drug development (as reflected in numerous unsuccessful clinical trials and limited therapeutic options)
- We have pioneered translational research into disease drivers and prognostic biomarkers, through a multitude of state-of-the-art methodologies that represent a blueprint for a new paradigm of science-driven drug development in HS
Clinical & Commercial Strategy
Track Chair:
Understanding Macroeconomics to Navigating a Nuanced Market & Poise Pipelines for Commercial Success
11:00 am Fireside Chat: Exploring the Investment Landscape in Dermatology Drug Development
Synopsis
- What are the essential factors considered when assessing opportunities in medical dermatology, and how can companies meet these criteria to secure funding?
- Amidst the dynamic nature of dermatology drug development, what are the primary hurdles and prospects that investors encounter, and how do these influence investment strategies?
- Which trends or advancements are particularly intriguing for investors within dermatology’s domain?
- What are today’s current investment perspectives on topical Vs systemic medicines? With particular consideration to JAK inhibitors
11:30 am Interactive Roundtable Discussion: Unlocking Market Access: An Exploration of the Reimbursement Paradigm to Expand Access to Novel Medicines
Synopsis
- Analyzing current trends and shifts in reimbursement policies specific to medical dermatology, with a focus on navigating hurdles related to prior authorization, formulary placement, and patient access barriers
- Discussing innovative reimbursement models and value-based strategies tailored to the inflammatory dermatology landscape, aimed at optimizing patient access while ensuring sustainable market success for drug developers
12:30 pm Networking Lunch
What Lies Ahead? Exploring Trends, Targets & Modalities for Strategic Insights
1:30 pm Entering the Clinic with a Precision Dermatology Approach: Novel Platform & Disease Model Approach
Synopsis
- Development of a novel live biotherapeutic product dermatology platform, leveraging microbial and protein engineering
- Clinical entry plans forward
- Development of unique models to progress a rare disease candidate for Netheron Syndrome
2:00 pm Discovery of Potent & Selective Oral STAT3 Inhibitors with Potential Efficacy & Safety Differentiation Versus JAK/ TYK2 Targeting
Synopsis
- SH2 domain discovery platform integrating DNA-encoded libraries and crystallography enabled drug design
- Optimizing inflammatory cytokine inhibition to achieve deep and durable immune modulation
- Utilizing translational assays to explore infection and hematologic homeostasis differentiation
2:30 pm Afternoon Networking Break
3:00 pm Bullous Pemphigoid: Exploring New Frontiers
Synopsis
- Describe the heterogenous clinical presentations, disease burden, and diagnosis of bullous pemphigoid (BP)
- Highlight current understanding of BP pathophysiology and the critical role of autoimmunity and type 2 inflammation in both clinical signs and itch
- Discuss unmet needs from a clinical management perspective and how targeted therapies may address them
3:30 pm Leading the Next Frontier in Treatment of Atopic Dermatitis
Synopsis
- Insights into translating a novel mechanism of action from initial phenotypic identification through target deconvolution
- Data package for our novel, differentiated and oral agent in AD models in vivo benchmarked against leading standard-of-care therapies / MoAs
- Share preliminary data on anti-inflammatory mechanism of our agent and potential in indications beyond AD
4:00 pm A Novel First-in-Class Senolytic Therapy for Treating Various Chronic Inflammatory Skin Conditions
Synopsis
- Chronic skin conditions like atopic dermatitis, psoriasis, and rosacea share an inflammatory environment that hinders healing
- Senescent cells contribute to this inflammation, driving immune responses that worsen disease progression and tissue degeneration, especially with aging
- Rubedo's Alembic platform identifies different types of senescent cells in diseased tissues. Using this platform, Rubedo develops selective senolytic drugs like RLS-1496, a first-in-class molecule targeting pathological skin senescent cells. This leading program, aimed at treating multiple dermatological conditions, is advancing into the clinical stage