EADV Update: New Data Back Sanofi's Leadership in Immune-Mediated Skin Diseases

Paris, September 25, 2024. Sanofi is set to present 39 abstracts at the 2024 European Academy of Dermatology and Venereology (EADV) conference in Amsterdam, showcasing both approved and investigational medicines. A significant portion of these presentations will spotlight Dupixent (dupilumab), developed in collaboration with Regeneron. The abstracts will delve into the treatment's efficacy in addressing conditions such as atopic dermatitis (AD), prurigo nodularis (PN), and chronic spontaneous urticaria (CSU). Notably, data from these studies will highlight Dupixent's potential for achieving disease remission in young children with moderate-to-severe AD, as well as its rapid efficacy in adults with PN.

Sanofi will also unveil findings from their immunology pipeline, with a focus on molecules such as amlitelimab, an OX40-ligand monoclonal antibody, and rilzabrutinib, a novel oral BTK inhibitor. These presentations include phase 2 data on amlitelimab's safety and efficacy in moderate-to-severe AD, alongside rilzabrutinib's impact on symptoms of AD and CSU.

Dietmar Berger, M.D., Ph.D., Chief Medical Officer and Global Head of Development at Sanofi, emphasized the significance of the data being presented. He highlighted the potential of Dupixent to meet critical treatment goals, such as clinical remission and enduring efficacy. Dr. Berger also expressed enthusiasm about the new pipeline data, particularly the promising results for amlitelimab, which suggest the possibility of quarterly dosing intervals with a favorable safety profile.

Key presentations regarding Dupixent include:

**Atopic Dermatitis (AD):**
- Multiple poster presentations will provide data on children aged 6-17 with moderate-to-severe AD, detailing clinical remission outcomes and long-term efficacy and safety for up to two years in children as young as six months.
- Real-world evidence will be shared on disease severity and quality of life for children aged six months to 11 years over a year-long period.
- An oral presentation will discuss global real-world safety data for adolescents and adults with moderate-to-severe AD.

**Prurigo Nodularis (PN):**
- Findings from the PRIME and PRIME2 clinical studies will be presented, showing new analyses on disease activity, itch relief, and skin clearance, with improvements observed as early as two weeks. The safety outcomes of these studies align with known safety profiles for Dupixent's dermatological uses.

The dermatology pipeline presentations will feature new data for amlitelimab and rilzabrutinib, investigating their applications in AD and CSU:

**Atopic Dermatitis (AD):**
- Six presentations will discuss amlitelimab's impact on moderate-to-severe AD, including a 68-week safety results presentation. Additional poster sessions will present a pharmacokinetic (PK) model supporting quarterly dosing potential, a post-hoc analysis of amlitelimab's effects on head and neck AD, and in vitro results showing that its anti-OX40L mechanism does not deplete T cells.
- A poster presentation will reveal rilzabrutinib's effects on itch in adults with moderate-to-severe AD.

**Chronic Spontaneous Urticaria (CSU):**
- Three poster presentations will explore rilzabrutinib's impact on itch, hives, and urticaria in adults with moderate-to-severe CSU.

Additional presentations will address:
- Hidradenitis suppurativa, emphasizing the disease's symptom impact and the need for better treatment options.
- Alopecia areata, showcasing a poster on clinical outcome measures and a conceptual model based on patient experiences.

Both amlitelimab and rilzabrutinib are investigational drugs, with their safety and efficacy yet to be evaluated by regulatory authorities.