With the recent developments in the atopic dermatitis (AD) market, the field is becoming more competitive as novel therapies are soon anticipated to enter the market. This evolution may benefit AD patients, especially those with moderate-to-severe AD.
Since their introduction with Sanofi/Regeneron’s Dupixent, 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 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 the OX40 inhibitor, which targets OX40 receptors and ligands. OX40 inhibitors may be promising as AD treatments, as key opinion leaders interviewed by leading data and analytics company GlobalData have shared their excitement about the effects that these drugs may bring to patients with AD.
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Currently, Amgen/Kyowa Kirin’s rocatinlimab is at the forefront of OX40 inhibitors for AD. Its promising Phase IIb clinical trial results have shown significant improvement in disease severity, with a durable off-treatment response after discontinuation, suggesting that it has a long-lasting effect. Furthermore, the recent topline results of one of the six Phase III clinical trials (ROCKET-Ignite) further reinforced rocatinlimab’s position, showing that 42.3% of patients who received a high dose met the improvement criteria of greater than or equal to 75% improvement from baseline based on the Eczema Area and Severity Index. Additionally, 23.6% of patients achieved a validated Investigator’s Global Assessment for Atopic Dermatitis score of 0-1 with at least a two-point reduction from baseline at week 24, supporting rocatinlimab’s potential as a new treatment option in AD.
Falling behind rocatinlimab, Astria Therapeutics’ telazorlimab and Sanofi’s amlitelimab are also competing with OX40 inhibitors in the AD landscape. The primary completion date for amlitelimab’s Phase III (SHORE) clinical trial is October 2025, and a data readout from this trial is highly anticipated by the medical community. In comparison to rocatinlimab and amlitelimab, telazorlimab 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, excitement around this new drug remains, with the experts in the field awaiting further results to understand its potential positioning in the AD market.
By offering a new mechanism of action (MOA), OX40 inhibitors may result 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.
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