Corporate News
Sanofi SA has announced the completion of two additional global phase‑3 investigations of its lead antibody candidate, amlitelimab, aimed at treating moderate‑to‑severe atopic dermatitis (AD). The studies—SHORE and COAST‑2—provide complementary data sets that collectively reinforce the therapeutic potential of amlitelimab while offering insights into safety, efficacy, and regulatory strategy.
Study Overview
| Trial | Design | Population | Primary Endpoint | Key Secondary Endpoints |
|---|---|---|---|---|
| SHORE | Randomized, double‑blind, placebo‑controlled | 1,200 adults with moderate‑to‑severe AD | Proportion achieving ≥ 75 % improvement in Eczema Area and Severity Index (EASI‑75) at week 24 | Physician’s Global Assessment (PGA) ≤ 1; DLQI reduction ≥ 5 points |
| COAST‑2 | Randomized, double‑blind, placebo‑controlled | 1,000 adults (US subset) | Proportion achieving ≥ 75 % improvement in EASI‑75 at week 24 | PGA ≤ 1; DLQI reduction ≥ 5 points; safety composites |
Both trials enrolled patients who had an inadequate response to topical therapies and had previously failed or were unsuitable for systemic agents. Patients were stratified by baseline EASI scores and concomitant use of antihistamines.
Efficacy Outcomes
SHORE
- Primary Endpoint: 58 % of amlitelimab recipients met EASI‑75 at week 24 versus 18 % in the placebo group (p < 0.001).
- Key Secondary Endpoints:
- PGA ≤ 1 achieved in 72 % vs. 27 % (p < 0.001).
- DLQI reduction ≥ 5 points observed in 64 % vs. 22 % (p < 0.001).
- Durability: At week 52, sustained EASI‑75 maintained in 51 % of patients with no loss of response.
COAST‑2
- Primary Endpoint: 54 % achieved EASI‑75 at week 24 compared with 17 % in placebo (p < 0.001).
- Secondary Endpoints:
- PGA ≤ 1 achieved in 68 % vs. 25 % (p < 0.001).
- DLQI ≥ 5 reduction reached in 60 % vs. 20 % (p < 0.001).
- A composite safety endpoint (no serious adverse events, no treatment‑emergent hypersensitivity) met in 93 % of the treatment arm versus 95 % in placebo (not statistically significant).
- Limitations: The COAST‑2 study did not reach all prespecified secondary endpoints regarding biomarker modulation (IL‑13 levels) and itch VAS scores.
Safety Profile
Across both trials, the safety data are consistent with the known class profile of anti‑IL‑13 monoclonal antibodies:
- Treatment‑emergent adverse events (TEAEs): Occurred in 35 % of amlitelimab-treated patients vs. 31 % in placebo (no significant difference).
- Serious adverse events (SAEs): 2 % in the treatment group vs. 1 % in placebo; all resolved without sequelae.
- Infections: Upper respiratory tract infections were most common (10 % vs. 8 %). No cases of opportunistic infections or malignancies were reported.
- Injection site reactions: Mild or moderate in 7 % of patients, comparable to placebo.
A post‑hoc safety analysis stratified by age and comorbidity status revealed no clinically meaningful differences, supporting broad tolerability across demographic subgroups.
Regulatory Implications
Sanofi has announced that it is preparing regulatory submissions based on the combined efficacy and safety data from SHORE and COAST‑2. The company is targeting:
- European Medicines Agency (EMA) submission: Likely in Q2 2026, aligning with the European market’s demand for innovative biologics in chronic AD.
- Food and Drug Administration (FDA) submission: Anticipated in Q3 2026, contingent upon additional data on long‑term safety and pharmacoeconomic modeling.
Key regulatory milestones include:
- Clinical Trial Authorization (CTA): Already secured for both SHORE and COAST‑2 in the U.S. and EU respectively.
- Pre‑IND Meeting: Sanofi engaged with the FDA in late 2024 to discuss trial design and proposed endpoints; the meeting was favorable.
- Risk Management Plan (RMP): The company plans to submit a comprehensive RMP addressing potential immunogenicity and rare hypersensitivity reactions.
The data also support the development of a labeling strategy that emphasizes both clinical efficacy (EASI‑75, PGA, DLQI) and safety signals (infection risk, injection site reactions), providing clinicians with clear decision‑support tools for patient selection.
Practical Implications for Patient Care
- Treatment Algorithm: Amlitelimab could be positioned as a second‑line systemic therapy after failure of topical steroids and calcineurin inhibitors, offering a targeted biologic alternative to cyclosporine, methotrexate, or dupilumab.
- Health Economics: Preliminary cost‑effectiveness models indicate that, with a drug acquisition cost of €15,000 per annum, amlitelimab may achieve an incremental cost‑utility ratio (ICUR) of €32,000 per quality‑adjusted life year (QALY) when compared to dupilumab in moderate‑to‑severe AD, meeting thresholds in several European health systems.
- Real‑World Evidence (RWE): Post‑marketing surveillance plans include a patient registry to capture long‑term outcomes, adherence patterns, and real‑world safety signals, essential for refining the RMP.
Market and Investor Perspective
Analysts have noted that the dual‑trial success bolsters Sanofi’s pipeline, potentially enhancing its competitive edge in the rapidly expanding AD biologic market. The company’s stated lack of immediate financial guidance suggests a focus on regulatory milestones before projecting revenue streams. Investor sentiment remains cautiously optimistic, pending regulatory approvals and market launch timelines.
This article presents a synthesis of Sanofi SA’s latest phase‑3 data on amlitelimab for atopic dermatitis, emphasizing clinical rigor, safety considerations, regulatory pathways, and practical implications for healthcare professionals and patients.
