By Fineline Cube Sanofi (NASDAQ: SNY) announced positive results from two global Phase III studies (SHORE and COAST 2) for amlitelimab, a fully human, non‑T cell‑depleting monoclonal antibody targeting OX40 ligand (OX40L), demonstrating efficacy in patients aged 12 years and older with moderate‑to‑severe atopic dermatitis (AD). The company plans global regulatory filings in H2 2026, positioning the asset as a conveniently dosed competitor to existing biologics.
Clinical Milestone
| Item | Detail |
|---|---|
| Company | Sanofi (NASDAQ: SNY) |
| Drug | Amlitelimab (anti‑OX40L monoclonal antibody) |
| Mechanism | Non‑T cell‑depleting, targets OX40 ligand to modulate T‑cell activation |
| Studies | SHORE and COAST 2 (Phase III) |
| Population | Patients aged ≥12 years with moderate‑to‑severe atopic dermatitis |
| Primary Endpoints | vIGA‑AD 0/1 with ≥2‑point reduction; EASI‑75 |
| Status | Positive topline results announced |
| Next Milestones | AQUA and ESTUARY studies (H2 2026); Global filings H2 2026 |
Drug Profile & Mechanism of Action
- Target: OX40 ligand (OX40L) – a key co‑stimulatory molecule driving T‑cell‑mediated inflammation in AD
- Differentiation: Non‑T cell‑depleting mechanism preserves immune function while dampening pathogenic T‑cell responses
- Dosing Advantage: Demonstrated efficacy with every‑4‑weeks (Q4W) and every‑12‑weeks (Q12W) regimens, offering superior convenience vs. bi‑weekly or monthly competitors
- Clinical Rationale: Addresses type 2 inflammation upstream, potentially offering durable disease modification
Clinical Evidence – Phase III Results
| Endpoint | Amlitelimab Q4W | Amlitelimab Q12W | Placebo | Study |
|---|---|---|---|---|
| vIGA‑AD 0/1 + ≥2‑point reduction | 28.7% | 32.3% | 16.8% | SHORE |
| EASI‑75 | 48.1% | 46.8% | 32.3% | SHORE |
| vIGA‑AD 0/1 + ≥2‑point reduction | 25.3% | 25.7% | 14.8% | COAST 2 |
| EASI‑75 | 41.8% | 40.5% | 24.2% | COAST 2 |
- Efficacy: Both dosing regimens demonstrated statistically significant improvements across primary and key secondary endpoints vs. placebo
- Consistency: Results replicated across two independent Phase III trials (SHORE and COAST 2)
- Safety: Profile consistent with prior studies; non‑T cell‑depleting mechanism supports favorable immunologic safety
Market Impact & Competitive Landscape
| Parameter | 2026E | 2027E | 2028E |
|---|---|---|---|
| Global AD Biologics Market | $18.5 billion | $22.3 billion | $26.8 billion |
| Moderate‑to‑Severe AD Patients (Global) | 65 million | 67 million | 69 million |
| Injectable Biologic Penetration | 28% | 32% | 36% |
| Amlitelimab Peak Share | 0% | 4% | 8% |
| Annual Treatment Cost (USD) | – | $35,000 | $32,000 |
| Sanofi Revenue (Amlitelimab) | – | $890 million | $2.1 billion |
Key Competitors:
- Dupixent (dupilumab, Sanofi/Regeneron) – IL‑4/IL‑13 inhibitor, market leader (Q2W dosing)
- Adbry (tralokinumab, Leo Pharma) – IL‑13 inhibitor (Q2W)
- Rinvoq (upadacitinib, AbbVie) – Oral JAK inhibitor
- Amlitelimab – First OX40L inhibitor with Q12W dosing option, potentially improving adherence and reducing healthcare burden
Strategic Positioning
- Dosing Differentiation: Q12W regimen represents longest interval among AD biologics, addressing patient preference for convenience and healthcare system cost savings (fewer clinic visits)
- Pipeline Synergy: Complements Sanofi’s immunology franchise alongside Dupixent; potential for combination therapy or sequential use in non‑responders
- Manufacturing: Leverages existing Sanofi biologics infrastructure; pre‑filled syringe/autoinjector presentation planned for commercial launch
- Global Launch: H2 2026 filings target US, EU, and Japan simultaneously; pediatric indication (≥12 years) expands addressable market vs. adult‑only competitors
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory filing timelines, commercial forecasts, and competitive positioning for amlitelimab. Actual results may differ due to regulatory review outcomes, AQUA/ESTUARY study results, and market access dynamics.-Fineline Info & Tech