The atopic dermatitis (AD) treatment landscape is witnessing intensified competition with several novel therapies nearing market entry. While biologics like dupilumab have already transformed care, emerging drug classes such as OX40 inhibitors are showing promise in clinical trials. Their potential for long-lasting efficacy and favorable safety profiles may significantly advance treatment options for moderate-to-severe AD patients, says GlobalData.
GlobalData’s report, “Atopic Dermatitis (AD) Epidemiology Analysis and Forecast to 2033,” reveals that the diagnosed prevalent cases of AD will register an annual growth rate of less than 1 per cent during 2023-2033 across the seven major markets (7MM: The US, France, Germany, Italy, Spain, the UK, and Japan).
Following the introduction of Sanofi/Regeneron’s Dupixent (dupilumab), biologics have had a dramatic impact on the AD space, offering targeted treatments with minimal side effects to patients with AD, who have previously exhibited inadequate responses to topical or immunomodulatory treatments.
Although oral treatments such as Janus kinase (JAK) inhibitors have entered the market and are paving the way for other oral therapies, they have demonstrated a strong side-effect profile that may not allow them to have a similar impact to Dupixent. A new drug class that is currently being investigated is OX40 inhibitors, which target OX40 receptors and ligands, providing an anti-inflammatory effect.
Filippos Maniatis, Healthcare Analyst at GlobalData, comments, “OX40 inhibitors may be promising as AD treatments, as the key opinion leaders interviewed by GlobalData have shared their excitement about the effects that these drugs may bring to patients with AD. At the moment, Amgen/Kyowa Kirin’s rocatinlimab is at the forefront of OX40 inhibitors for AD, followed by Astria Therapeutics’ telazorlimab, and Sanofi’s amlitelimab, the readouts of which are highly anticipated by the community.”
Rocatinlimab has previously demonstrated significant improvement in disease severity, with a durable long-lasting effect, as seen in the Phase IIb, results. In addition, the recent topline results of one of the six Phase III clinical trials that have further reinforced rocatinlimab’s position, showing that 42.3 per cent of patients who received a high dose met the improvement criteria of ≥75 per cent improvement from baseline based on the Eczema Area and Severity Index (EASI-75), brings rocatinlimab closer to a potential approval for AD.
Maniatis adds, “Rocatinlimab is currently ahead of the other OX40s being investigated in AD, showing very promising results. Nevertheless, as Sanofi’s OX40 inhibitor amlitelimab is also in Phase III with a primary completion date in October 2025, it will be interesting to see what the outcomes reported for amlitelimab will be and how they compare to rocatinlimab’s studies.”
Telazorlimab, which is another OX40 inhibitor in the pipeline within AD developed by Astria Therapeutics, is currently behind on development, as its Phase IIb trial has been completed and the results have demonstrated a well-tolerated and clinically significant profile. Nevertheless, the excitement around this new drug remains, with the experts in the field awaiting further results to understand their potential positioning in the AD market.
Maniatis concludes, “OX40 inhibitors offer a new mechanism of action to a crowded market, with the potential of resulting in a shift in clinical practice. The potential long-lasting effects of these pipeline agents, as seen with rocatinlimab, and their good clinical profiles may offer a significant advancement in AD management, addressing current unmet needs and increasing the anticipation for these potential therapies in the AD market.”