Analysts at Leerink agreed with Sanofi that, despite falling short of statistical significance in the Phase II TIDE-Asthma trial, amlitelimab warrants further development in this indication.
Sanofi’s amlitelimab, the centerpiece of the pharma’s $1.4 billion acquisition of Kymab, failed to significantly reduce disease exacerbations in patients with moderate-to-severe asthma in a mid-stage trial. Nevertheless, Sanofi insisted that amlitelimab’s treatment benefits were “clinically meaningful” and that the results support further study of the asset in asthma.
Analysts at Leerink Partners agreed, telling investors in a Tuesday note that “these findings support continued development despite the missed 48-[week] primary endpoint.” The preliminary readout released Tuesday comes from the Phase II TIDE-Asthma trial.
In particular, Leerink pointed to Sanofi’s data in the subgroup of patients with at least 300 eosinophils/mL and elevated levels of neutrophils. According to Tuesday’s release, amlitelimab was able to reduce asthma exacerbations by more than 70% in this population at week 60, alongside improvements in lung function.
This matches or exceeds the performance of Sanofi and Regeneron’s prized drug Dupixent and Amgen and AstraZenca’s Tezspire—two products that are dominant in the asthma market. The drugs have “demonstrated a risk reduction in annualized exacerbation rates [versus placebo] of 66-70% in these patient subgroups,” the Leerink group wrote.
Sanofi also revealed on Tuesday that amlitelimab was able to elicit only “nominally significant” improvements in secondary endpoints, including lung function and asthma control. Still, the pharma called the drug’s efficacy profile “compelling,” saying that amlitelimab “has the potential to improve key disease outcomes” in asthma.
The pharma is currently in the process of planning a Phase III trial for amlitelimab in this indication, as per the Tuesday announcement.
Amlitelimab, an investigational monoclonal antibody, works by targeting OX40L, a central player in the regulation of the immune response. This mechanism of action holds potential to rebalance the immune system, according to Sanofi, in turn addressing several immune-mediated and inflammatory conditions.
Leerink pointed out that Sanofi has named amlitelimab “as one of its top three pipeline assets, with peak sales potential exceeding €5 billion.” The bulk of this opportunity, according to the analysts, comes from the atopic dermatitis market. Phase IIb data in June 2023 showed that amlitelimab significantly reduced eczema severity in patients with moderate-to-severe disease. Additional data are expected in 2026, Leerink noted.
Aside from asthma and atopic dermatitis, Sanofi is also trialing amlitelimab in hidradenitis suppurativa, alopecia areata, celiac disease and scleroderma.
