Day Two

Thursday 18th April 2024

8:00 am Check In, Morning Coffee & Light Breakfast

8:50 am Chair’s Opening Remarks

  • Elena Rizova Vice President, Head Medical Affairs Biogen Intercontinental Region, Biogen

Towards First-in-Human: Taking Compounds to the Clinic

9:00 am Development of a Topical Containing a Non-Coding Oligonucleotide

Synopsis

• Proof-of-concept study in canines with atopic dermatitis

• Cutaneous CD11b+ cells that inhibit Th1/2/9 responses and promote Tregs are recruited by a non-coding oligonucleotide

• Upregulation of immune-checkpoint proteins on cutaneous CD11b+ cells

9:30 am Targeting the CCR4 Pathway in Atopic Dermatitis with RPT193: a Novel Approach Seeking to Revolutionise Oral Drug Development in Atopic Dermatitis

Synopsis

• CCR4 drives a key biological pathway that causes atopic dermatitis with RPT193 being a highly potent, oral, once-daily CCR4 antagonist

• Phase 1 data indicate that RPT193 as monotherapy demonstrates clear benefit on the signs of symptoms of atopic dermatitis as well as on a skin AD-gene signature with a favorable PK and safety profile

• RPT193 is being investigated in a large Phase 2 study in patients with moderate-to-severe atopic dermatitis with data due to read out in mid-2024

10:00 am Morning Break & Networking

Synopsis

Meet and connect with your peers in this dedicated networking session

Clinical Strategies in Dermatology: Clinical Progress & Novel Strategies Shaping Today’s Drug Development Landscape

11:00 am Rezpegaldesleukin, a Regulatory T-Cell Selective IL-2 Conjugate: Lessons Learned From Preclinical Design to Clinical Evaluation in Inflammatory Skin Diseases Including Atopic Dermatitis

Synopsis

• Use of the appropriate design elements and experimental models for generation and preclinical evaluation

• Using clinical development approaches to address target engagement and assess PK/PD principles

• Using clinical studies to identify the correlation between the MOA and the indication

11:30 am Translating Molecular Features Into Patient Benefit: Improving Tissue Penetration

Synopsis

• Affibody® constructs can be engineered to achieve a multitude of competitive advantages

• Examples are very high target affinity, better tissue penetration through small size and albumin binding

• These beneficial features have translated into meaningful clinical outcomes in patients with psoriatic arthritis and hidradenitis suppurativa

12:00 pm Expanding the Role of the IL-17A & IL-17F inhibiting Nanobody® Sonelokimab Across Derm & Rheum Indications – Data from a Global Placebo- & Active Comparator-Controlled Phase 2 Study in Psoriatic Arthritis

  • Kristian Reich Chief Scientific Officer, MoonLake Immunotherapeutics AG

Synopsis

  • Explore the rapid achievement of high response levels in joints and skin across ACR and PASI thresholds, as well as composite measures such as MDA, shedding light on the dynamics of clinical response patterns
  • Consistent safety results observed in the ARGO and previous sonelokimab trials, emphasising the absence of new safety signals and contributing additional insights into the safety profile of IL-17 inhibitors
  • Investigate the broader impact of sonelokimab on patient-reported quality of life, and across psoriatic disease domains, examining the depth of response beyond the primary endpoint, and its significance in the context of improving the overall well-being of patients

12:30 pm Lunch Break

Synopsis

Take this chance to meet the expert speakers, connect with your peers and explore our exhibition booths

2:00 pm Small Molecule Safety: Minimising Off-Target Effects for the Development of Safer & More Efficacious Treatments

Synopsis

• Clinical updates demonstrating improved safety of small molecule therapies in immunologic conditions

• How can the precision of inflammatory signaling molecules be improved to selectively modulate the immune system

• Addressing compound safety profiles to improve efficacious therapeutic options for dermatology disease with inflammatory pathogenesis

Navigating European Healthcare Infrastructure: Enabling Accuracy in Diagnosis & Expanding Access to Novel Therapeutics

2:30 pm Roundtable Discussion:Navigating & Re-Thinking Market Access Strategies in European Dermatology Drug Development

Synopsis

In the dynamic landscape of dermatology drug development, securing successful market

access in Europe is a pivotal milestone for biopharma innovators. This interactive discussion brings together large pharma, biotech, clinician and market access strategists to delve into the crucial considerations for planning ahead in this complex journey in a more informed manner compared to today.

Use this opportunity to discuss the intricacies of European regulatory, HTA criteria and payer engagement strategies to optimise development timelines, approval processes, craft reimbursement models and ultimately navigate diverse markets to maximise patient access to novel therapies.



Join us for a collaborative exploration of strategies and insights that will empower

your end-to-end dermatology drug development journey in the European market!

3:30 pm Adopting Novel Strategies for Chronic Skin Conditions in Clinical Practice

  • Elisabeth Riedl Associate Professor - Department of Dermatology, Medical University of Vienna

Synopsis

• Given the latest developments and approvals of new treatments in dermatology, are these therapies proving effective and safe when applied in real-world clinical scenarios?

• Are the newly available treatments in dermatology leading to sustained improvements in patients’ quality of life over time?

• How can learnings from clinical practice inform future research and the evolution towards a personalised medicine approach in treating dermatologic conditions?

4:45 pm Chair’s Closing Remarks & End of Summit

  • Elena Rizova Vice President, Head Medical Affairs Biogen Intercontinental Region, Biogen