Sanofi (SASY.PA) Detailed Phase 2 AIRCULES lunsekimig data largely in line with Tezspire on FEV1, with lower exacerbation re...

Equity Research 8 September 2026 | 5:17PM BST

Sanofi (SASY.PA): Detailed Phase 2 AIRCULES lunsekimig data largely in line with Tezspire on FEV1, with lower exacerbation reduction

Detailed Phase 2b AIRCULES data for lunsekimig in moderate to severe asthma were James Quigley | presented at the European Respiratory Society meeting today (Sep 8) and appear Goldman Sachs International largely in line with the efficacy bar set by AZN’s Tezspire. Across the doses disclosed, Rajan Sharma lunsekimig achieved a 38-55% reduction in AAER versus placebo, alongside a | 0.10-0.13L improvement vs. placebo in pre-BD FEV1, while Tezspire demonstrated a Goldman Sachs International

61-71% benefit vs. placebo on exacerbation reduction, with a 0.11-0.12L Shyam Kotadia | improvement in FEV1 vs. placebo in its Phase 2b study (excluding the high dose - that Goldman Sachs International was subsequently not approved). While encouraging, the dose response was mixed, with the 60mg Q4W and 300mg Q8W demonstrating similar AAER reduction Kaaviya Ganesan | (despite a higher average dose for the 300mg Q8W), while the highest dose disclosed Goldman Sachs India SPL of 300mg Q4W had the strongest AAER reduction. However, on FEV1 improvements, Max Da, Ph.D. the lower dose (60mg Q4W) showed the strongest improvement, followed by the | Goldman Sachs International 300mg Q4W and then the 300mg Q8W. Overall, we believe the detailed AIRCULES Theodora Rowe Beadle data further de-risk the lunsekimig program ahead of Phase 3; also, the lack of a | clear dose response could warrant caution, as we note the dose response in Phase 2 Goldman Sachs International

for Tezspire was also somewhat mixed on AAER and FEV1. Noting the limitations of cross-trial comparison and differing time points (Week 48 for lunsekimig vs. Week 52 for Tezspire), these data suggest that, despite the lower efficacy on exacerbation reduction, lunsekimig could offer differentiation on better lung function, giving physicians/patients another option in asthma treatment. We include €2bn in unadjusted peak sales at a 50% PoS for lunsekimig in our model.

Key takeaways from the poster:

n Exacerbation reduction: Lunsekimig 300mg Q4W achieved a 55.3% reduction in AAER versus placebo (0.314 vs. 0.702; p=0.0016). Efficacy was particularly pronounced in patients with greater disease burden, with AAER reductions of 62.9% in patients with ≥2 prior exacerbations in the past year and 86.9% in those with ≥3 prior exacerbations, suggesting greater treatment benefit in a more severe population. Greater benefits were also observed in patients with elevated Type 2 biomarkers, including 65.1% AAER reduction in FeNO ≥25 ppb and 70.6% reduction in eosinophils ≥300 cells/μL. This is slightly lower than what was seen with Tezspire, which demonstrated a 61-71% benefit in its Phase 2 trial. n Lung function benefit: Lunsekimig 300mg Q4W demonstrated a 0.125L placebo-adjusted improvement in pre-BD FEV1 at Week 48 (p=0.0183), broadly in line with the ~0.13L placebo-adjusted improvement reported with Phase 3

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Goldman Sachs Sanofi (SASY.PA)

Tezspire. However, lung function improvements do not demonstrate a clear dose-response relationship for FEV1, with placebo-adjusted FEV1 gains of 0.134L (60mg Q4W), 0.100L (300mg Q8W), and 0.125L (300mg Q4W), suggesting that the substantially greater exacerbation benefit with 300mg Q4W was not accompanied by differentiated lung function improvements. Of note, this appears consistent with Tezspire’s Phase 2 data, where improvements in FEV1 were also relatively similar across active dose arms even as exacerbation efficacy appeared more differentiated. n ACQ-5 and time to first…