A Deep Dive Into the OCEANIA

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21 Aug 2025

Transcript key insights: 

• OX40L inhibition appears superior to targeting OX40 receptor and could theoretically offer longer-lasting responses. However, specialist questions the utility when long-acting interleukin-13 inhibitors such as APG777 can be dosed Q12W or potentially Q24W.
• Bar to beat for amliteliamb Q4W is to exceed dupilumab's placebo-adjusted 32-36% EASI-75 benefit, with comparable safety and no monitoring requirements. If amlitelimab Q4W matches dupiliumab's efficacy, it wouldn't be sufficiently differentiated, especially given lebrikizumab dosing can be pushed out to Q4W. Amlitelimab Q12W's bar is to at least match dupilumab's efficacy. Importantly, however, APG777 may set the new bar, while phase 2 data are hard to unpack, given placebo responses and lower baseline EASI scores, it has the potential for higher efficacy and Q12/24W dosing.
• STREAM-AD efficacy at 16 weeks, at face value, appears to be on lower end of the biologics spectrum. While amlitelimab's responses deepen over time such that efficacy at week 24 is comparable to dupilumab's, asking patients to wait half a year to obtain comparable efficacy isn't satisfactory. Amlitelimab's safety looks to be comparable and non-overlapping with anti-interleukin-13s, with no conjunctivitis being a clear positive.
• Rocatinlimab's ROCKET data were disappointing. Step-down in efficacy likely driven by increased proportion of biologics-experienced patients vs phase 2 – an inevitable consequence of more therapies on the market. Thus, specialist cautions amlitelimab and APG777's phase 3 data may similarly be impacted.
• Amlitelimab's efficacy in COAST 1 is therefore likely to decrease as it will enrol a higher proportion of biologics-experienced and severe patients vs STREAM-AD. Specialist expects placebo-adusted EASI-75 benefit for Q4W arm dropping to the low-30s at 24 weeks, ie, below Dupixent. Consequently, Q12W dosing is crucial for amlitelimab differentiation, with specialist being cautious about a positive result, given study duration. While the ESTUARY maintenance study is better-powered to capture amlitelimab's Q12W profile, the fact remains that patients will likely have to wait a long time to see comparable results to existing biologics. In summary, specialist isn't overly optimistic that amlitelimab represents a transformative therapy.

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