Amlitelimab Phase 3 Studies Show Mixed Results in Atopic Dermatitis, Sanofi Plans Global Submissions

summarizeSummary

Sanofi reported mixed Phase 3 clinical trial results for amlitelimab in atopic dermatitis, with one study fully positive and another missing EU endpoints, but confirmed plans for global regulatory submissions.

check_boxKey Events · Product Development and Regulatory · SNY

• SHORE Phase 3 Study Success

  Amlitelimab, in combination with topical therapies, met all primary and key secondary endpoints at Week 24 in the SHORE Phase 3 study for moderate-to-severe atopic dermatitis.

• COAST 2 Phase 3 Study Mixed Results

  Amlitelimab monotherapy met the primary endpoint for US and US reference countries in the COAST 2 study but did not achieve statistical significance for co-primary endpoints in the EU and EU reference countries.

• Positive ATLANTIS Phase 2 Long-Term Data

  Preliminary analysis of the ATLANTIS Phase 2 study showed continued and progressive improvements in skin clearance and disease severity through Week 52, with a consistent safety profile.

• Global Regulatory Submissions Planned

  Based on the totality of data, Sanofi will move forward with global regulatory submissions for amlitelimab in the second half of 2026.

auto_awesomeAnalysis · SNY · Life Sciences

Sanofi announced mixed Phase 3 results for its atopic dermatitis drug candidate, amlitelimab. While the SHORE study met all primary and key secondary endpoints, the COAST 2 study failed to achieve statistical significance for co-primary endpoints in the EU and EU reference countries, despite meeting US endpoints. This indicates a potential challenge in a major market. However, the company's decision to proceed with global regulatory submissions, supported by positive SHORE data and long-term Phase 2 results, suggests confidence in the drug's overall profile and market potential. Investors will monitor the regulatory submission process and further data releases, especially concerning the EU market strategy.