Sanofi halts Amlitelimab Atopic Dermatitis pipeline ahead of dupixent patent expiry

FRANCE—Sanofi has decided not to pursue regulatory approval or continue development of its immunology drug amlitelimab for atopic dermatitis (AD), a setback for the drugmakers as it seeks a successor to its blockbuster drug Dupixent (dupilumab), whose patent is about to expire.

Following a strategic review, Sanofi halted development of the OX40 ligand blocker in AD, concluding that the drug was unlikely to deliver “meaningful improvements” over the current standard of care (SoC).

Although amlitelimab demonstrated efficacy across its Phase III programme, it failed to meet a co-primary endpoint in the COAST 2 study (NCT06181435).

The result has prompted some analysts to question whether the broader OX40 drug class can secure a significant position in the first-line AD market.

The latest decision marks another setback for amlitelimab, which Sanofi had previously positioned as a potential successor to Dupixent, its best-selling immunology asset.

The company has also discontinued development programmes evaluating amlitelimab in asthma, alopecia and hidradenitis suppurativa (HS).

Competitive and safety concerns

According to Tanuj Sircar, associate director of Competitive Intelligence at GlobalData, Sanofi’s decision to discontinue amlitelimab at the pre-registration stage is surprising.

However, he said the move could reflect competitive pressures in AD and related indications. GlobalData is the parent company of Pharmaceutical Technology.

Despite the setback, Sanofi continues to evaluate amlitelimab in other disease areas. The company is advancing a Phase II study of the drug in celiac disease and expects to report results in the second half of 2026.

Meanwhile, the OX40 drug class faces growing challenges.

Kyowa Kirin recently terminated development of its OX40 receptor blocker rocatinlimab after some patients treated with the drug developed Kaposi sarcoma, a rare cancer affecting blood and lymphatic vessels.

Sircar said these cases could increase scrutiny of amlitelimab’s safety profile and potentially weaken its commercial value and broader franchise potential.

 According to a paper published in Frontiers, two patients treated with amlitelimab previously developed Kaposi sarcoma.

“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 said.

OX40 pipeline faces uncertainty

“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.

Looking ahead, Sircar expects Sanofi to redirect investment towards Dupixent and emerging oral treatments for AD.

These include KT-485, an IRAK4 degrader co-developed with Kymera Therapeutics, and NX-3911, a STAT6 degrader acquired from Nurix Pharmaceuticals.