On Thursday, Sanofi SA SNY stock tumbled after late-stage trial results for amlitelimab, its potential successor to blockbuster eczema drug Dupixent, failed to match investor expectations, raising fresh doubts about the company’s ability to sustain its dermatology franchise once patent protections expire.Results from the global COAST 1 phase 3 study showed that amlitelimab met all primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful skin clearance and diseas ...

pruritus, and pain, is driven by skin barrier disruption and T-cell-dependent inflammatory pathways. Expansion of OX40R+ pathogenic T cells leads to T-cell imbalance, a root cause of inflammatory diseases including AD. Title: Efficacy & Safety of OX-40 Receptor Targeting with Rocatinlimab in Moderate-to-Severe Atopic Dermatitis: Results from the Phase 3 ROCKET-IGNITE Trial Presenter: Emma Guttman-Yassky, MD, PhD Date: Friday, September 19th Time: 4:40 – 4:50 pm CEST Session: FC 08 Atopic Dermatitis Location ...

Core Insights - Kyowa Kirin Co., Ltd. announced the presentation of Phase 3 ROCKET HORIZON trial results for rocatinlimab, targeting OX40 receptor in moderate-to-severe atopic dermatitis, at the AAD 2025 Annual Meeting [1][2] Group 1: Clinical Trial Details - ROCKET HORIZON is a Phase 3, randomized, placebo-controlled, double-blind trial involving 726 adult patients, assessing the efficacy, safety, and tolerability of rocatinlimab administered subcutaneously every four weeks for 24 weeks [3] - Co-primary endpoints include achieving a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-ADTM) score of 0 or 1 with a ≥ 2-point reduction from baseline at week 24, and a ≥ 75% reduction from baseline in Eczema Area and Severity Index score (EASI-75) at week 24 [3] - Key secondary endpoints focus on the impact of rocatinlimab on itch, safety, and tolerability [3] Group 2: Atopic Dermatitis Overview - Atopic dermatitis is a chronic inflammatory disease affecting 15-20% of children and up to 10% of adults, characterized by excessively dry, itchy skin and unpredictable flare-ups [4] - T-cell imbalance is identified as a root cause of atopic dermatitis, contributing to its clinical manifestations [4] Group 3: Rocatinlimab Overview - Rocatinlimab is an anti-OX40 receptor human monoclonal antibody under investigation for moderate-to-severe atopic dermatitis, as well as for moderate to severe uncontrolled asthma and prurigo nodularis [5] - The antibody was discovered through collaboration between Kyowa Kirin and La Jolla Institute for Immunology [5] Group 4: Collaboration with Amgen - Kyowa Kirin and Amgen entered a collaboration agreement on June 1, 2021, for the joint development and commercialization of rocatinlimab, with Amgen leading the global development except in Japan [6] - If approved, both companies will co-promote rocatinlimab in the United States, with Kyowa Kirin having opt-in rights for co-promotion in select markets [6]