Sanofi has chosen not to file for approval or continue the development of its immunology therapy, amlitelimab, in atopic dermatitis (AD) – dealing a blow to the company’s efforts to secure a successor for blockbuster drug Dupixent’s (dupilumab) as the drug’s patent expiry looms.
After a strategic review, the French pharma giant put a stop to the OX40 ligand blocker’s development programme in AD due to its belief that the drug would not offer “meaningful improvements” over the standard of care (SoC). While amlitelimab did display efficacy across its Phase III programme, the drug failed to meet its co-primary endpoint in the COAST 2 study (NCT06181435) – leading some analysts to doubt the ability of the wider OX40 drug class to penetrate the first-line market in AD.
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This AD discontinuation marks another setback for amlitelimab’s market prospects, which was once touted as a potential successor to Sanofi’s best-selling immunology asset, Dupixent. Previously, Sanofi previously canned development programmes for the drug focused on asthma, alopecia and hidradenitis suppurativa (HS).
According to Tanuj Sircar, associate director of Competitive Intelligence at GlobalData, Sanofi’s decision to discontinue amlitelimab at the pre-registration stage is surprising, though it’s likely attributed to competitor dynamics within the space and adjacent indications. GlobalData is the parent company of Pharmaceutical Technology.
However, there could still be hope for the drug’s market prospects, as Sanofi is currently forging on with its Phase II study on amlitelimab in celiac disease, which the company expects to read out in the second half of 2026.
OX40 class takes another hit
Amlitelimab’s discontinuation in AD comes as challenges continue for the OX40 drug class. Kyowa Kirin has terminated its development programme for its OX40 receptor blocker, rocatinlimab, after some patients given the drug developed rare blood vessel cancer, Kaposi sarcoma.
These malignancies, Sircar says, likely cast scrutiny on amlitelimab’s safety profile – potentially eroding the drug’s value and franchise potential. Previously, two patients treated with amlitelimab have developed Kaposi’s sarcoma, according to a paper published in Frontiers.
“Amlitelimab’s discontinuation draws parallels to its peer, rocatinlimab, and the discontinuation of both assets prior to filing will likely damage stakeholder perception of the class,” Sircar commented.
“Industry momentum for OX40s will likely wind down, though Inmagene’s non-depleting anti-OX40-R, IMG-007, is in Phase IIb development and it remains to be seen if AbbVie will continue development of Apogee’s OX40L, APG990,” he added.
Moving forward, Sircar theorises that Sanofi will redirect its investments towards Dupixent, as well as in oral modalities such as its Kymera Therapeutics co-developed IRAK4 degrader, KT-485 and its Nurix-acquired STAT6 degrader, NX-3911, in AD.
