French drugmaker Sanofi SA (NASDAQ:SNY) stock fell sharply Thursday after late-stage trial results for amlitelimab, its potential successor to blockbuster eczema drug Dupixent, failed to match investor expectations, raising fresh doubts about the company’s ability to sustain its dermatology franchise once patent protections expire.
Results from the global COAST 1 phase 3 study showed that amlitelimab met all primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful skin clearance and disease severity compared to placebo at Week 24 in patients aged 12 years and older with moderate-to-severe atopic dermatitis.
Amlitelimab was well-tolerated, with no new safety concerns identified in this study.
Sanofi reported EASI-75 (proportion of patients reaching a 75% or greater improvement in the eczema area and severity index total score) of 35.9% and 46% at Q4W vs. 19.1% on placebo and 39.1% and 50.3% at Q12W vs. 27.6%, depending on which patients were included.
The drugmaker also reported validated investigator global assessment scale for atopic dermatitis (vIGA-AD) 0/1 of 21.1% and 22.5% vs. 9.2% and 26.5% and 29.1% vs. 10.5%, again depending on which patients were included.
The OCEANA clinical development program of amlitelimab in atopic dermatitis, which includes COAST 1 and four other phase 3 studies (SHORE, COAST 2, AQUA, and ESTUARY), is anticipated to read out through 2026 and comprises the foundation for potential global regulatory submissions.
Investors are reacting as the data looked weak against Sanofi’s best-selling medicine, Dupixent, which is approved for atopic dermatitis and other indications and is due to lose patent protection in 2031.
Dupixent is co-owned by Regeneron Pharmaceuticals Inc. (NASDAQ:REGN).
Sanofi had positioned amlitelimab as a potential Dupixent successor, and Reuters, citing a Barclays analyst, noted that investors saw it as the company’s key pipeline asset before the data release.
Analysts at Jefferies told Reuters that the Phase 3 results fell short of its earlier trial and of rival biologic drugs. However, the drug’s safety profile and convenient 12-week dosing could still support its use.
Price Action: SNY stock is down 8.52% at $45.64 during the premarket session at the last check on Thursday.
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