Preliminary results from the TIDE-Asthma phase II study demonstrates amlitelimab's compelling efficacy in heterogeneous inflammatory asthma.- Sanofi

Sanofi shared new progress from its mid- to late-stage respiratory pipeline, including preliminary phase II results for amlitelimab in adults with moderate-to-severe asthma.

Amlitelimab: clinically meaningful efficacy in asthma; Preliminary results from the TIDE-Asthma phase II study (clinical study identifier: NCT05421598) show that the primary endpoint of annualized exacerbation rate at week 48 was not met at the highest dose level, leading to nominal significance at the medium dose. However, the study demonstrates amlitelimab's compelling efficacy in heterogeneous inflammatory asthma, potentially representing a breakthrough for this underserved patient population if observed in later studies. Treatment with amlitelimab led to nominally significant and clinically meaningful reductions in asthma exacerbations at the medium dose tested and a numerically greater reduction in exacerbations at the high dose at week 60. The study also demonstrated nominally significant and clinically meaningful improvement in secondary endpoints of lung function and asthma control. Notably, in a patient sub-group defined by biomarkers (eosinophils ≥300 cells/ml and elevated neutrophils), amlitelimab showed nominally significant and clinically meaningful improvements in exacerbations (with a reduction of more than 70%), lung function and asthma control at week 60. These results demonstrate that amlitelimab has potential to improve key disease outcomes in asthma patients with continued unmet need. The phase III program is currently being planned.

Houman Ashrafian Executive Vice President, Head of Research & Development: “We are pleased by the significant progress we have made with our pipeline across respiratory indications. In asthma, amlitelimab shows potential as an effective, long-acting medicine, including in patients with moderate-to-severe heterogenous inflammation. If the preliminary effect we have seen is confirmed in phase III studies, amlitelimab could become a differentiated treatment option in asthma. These data validate our strategy to advance innovative science and provide new solutions for patients with challenging-to-treat respiratory diseases.”

Amlitelimab has a unique non-depleting mechanism of action targeting OX40-Ligand with the potential to durably restore immune balance, with a sustained effect and infrequent dosing. In the TIDE-Asthma study, patients were treated every four weeks for the first 24 weeks and every 12 weeks for the remaining 36 weeks. The durable efficacy shown by amlitelimab through 60 weeks of treatment supports a quarterly maintenance dosing schedule. The safety profile was consistent with previous studies across indications, with no new safety signals identified throughout the 60-week treatment period. The incidence of treatment emergent adverse effects (TEAEs) or treatment discontinuation was similar between the amlitelimab and the placebo groups. The most frequent TEAEs (≥ 5% in any arm) more common (≥ 1%) than placebo were COVID-19, bronchitis, acute sinusitis and headache. All were mild-to-moderate in severity and all non-serious.

Full and final results will be presented at a forthcoming medical meeting.

About TIDE-Asthma
The phase II TIDE-Asthma study is a randomized, double-blind, placebo-controlled, dose-ranging study, evaluating amlitelimab as an add-on therapy in 437 adults with moderate-to-severe asthma. Participants were on standard-of-care medicines with medium-to-high doses of inhaled corticosteroids and up to two other controllers. The study included three dose levels of amlitelimab, each with a loading dose administered every four weeks for the first 24 weeks, followed by once every 12 weeks until week 60, with participants randomized 2:1:2:2 to receive one of the three active doses or placebo. The primary endpoint was the annualized rate of severe asthma exacerbations. Key secondary endpoints include lung function (pre-BD FEV1) and asthma control (ACQ-5).