Two recent clinical trial updates highlight the growing momentum of OX40-targeted therapies for atopic dermatitis (AD), underscoring an emerging strategy for long-term disease control.
Sanofi’s Amlitelimab
Sanofi recently announced positive topline results from the Phase 3 COAST-1 trial of amlitelimab, a fully human, non-T cell depleting monoclonal antibody that targets OX40-ligand (OX40L). Participants in the study were dosed either every four weeks or every twelve weeks. Results showed significant improvements in skin clearance and disease severity at Week 24 in patients aged 12 and older with moderate-to-severe AD compared to placebo.
The trial met all primary and key secondary endpoints, demonstrating clinically meaningful efficacy and a consistent safety profile across dosing arms. These findings reinforce the potential of amlitelimab to provide a less frequent, durable treatment option for patients requiring long-term control. Amlitelimab was well-tolerated, with no new safety concerns identified. The most common treatment-emergent adverse events (TEAEs) were AD, nasopharyngitis, and upper respiratory tract infection—all of which occurred more often in the placebo arm than in amlitelimab-treated patients.
Houman Ashrafian, executive vice president, head of research and development at Sanofi, said:
“These positive first phase 3 results of amlitelimab reinforce the potential of targeting the OX40-ligand to normalize the overactive immune system, without depleting T cells. Amlitelimab may represent a significant advance in the treatment of atopic dermatitis with clinically meaningful and progressively increasing efficacy, with the potential of dosing only four times per year. These promising data seen in a study population that more closely resembles today’s diverse patient landscape, including a substantial proportion previously treated with advanced therapies, support our ambition to deliver a differentiated medicine. We look forward to sharing additional phase 3 results from the OCEANA clinical development program.”
Amgen and Kyowa Kirin’s Rocatinlimab
Separately, Amgen and Kyowa Kirin reported topline data from the Phase 3 ASCEND long-term extension trial of rocatinlimab, a monoclonal antibody that targets the OX40 receptor.
The ongoing ASCEND study includes approximately 2,600 patients with moderate-to-severe AD who previously completed a ROCKET program trial (IGNITE, HORIZON, SHUTTLE, ASTRO, ORBIT, or VOYAGER). Participants then entered ASCEND for an additional 32 weeks of treatment with either 150 mg or 300 mg of rocatinlimab, administered every 4 or 8 weeks.
The primary endpoint was long-term safety. Results showed that the most common TEAEs were upper respiratory infections (including nasopharyngitis and pharyngitis), aphthous ulcers, headache, influenza, cough, and rhinitis—a safety profile consistent with findings from prior ROCKET studies. Discontinuation rates due to adverse events were low across adult cohorts treated with rocatinlimab.
Jay Bradner, M.D., executive vice president of research and development at Amgen, stated,
"Atopic dermatitis is a heterogeneous disease where many patients still lack adequate control with current therapies. These findings add to our understanding of the role OX40 inhibition can play in addressing the underlying drivers of this chronic disease and provide further information on rocatinlimab's durability of response and long-term safety profile, which we will continue to monitor."
Looking Ahead
While the two programs approach the OX40 pathway from opposite sides—amlitelimab by blocking the ligand and rocatinlimab by blocking the receptor—they share a common goal: offering durable treatment options for patients with moderate-to-severe AD. These new developments underscore the therapeutic promise of targeting the OX40/OX40L pathways in immune-mediated skin disease and point toward a potentially transformative new era in AD care.
Sources:
- Press Release: Sanofi’s amlitelimab met all primary and key secondary endpoints in the COAST 1 phase 3 study in adults and adolescents with atopic dermatitis
- Amgen And Kyowa Kirin Announce Top-line Results from Rocatinlimab Phase 3 Ascend Long-term Extension Study in Adults with Moderate to Severe Atopic Dermatitis
