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    Sanofi Asthma Drug Misses Primary Goal, Plans For Pivotal Study

    Benzinga·04/15/2025 18:08:43
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    Sanofi SA (NASDAQ:SNY) on Tuesday shared progress from its mid- to late-stage respiratory pipeline.

    The French drug maker reported preliminary results from the TIDE-Asthma phase 2 study of amlitelimab and its efficacy in heterogeneous inflammatory asthma. Here’s what we know:

    • The primary endpoint of the annualized exacerbation rate at week 48 was not met at the highest dose level, leading to nominal significance at the medium and low doses.
    • 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.
    • A nominally significant and clinically meaningful improvement in secondary endpoints of lung function and asthma control was evident.
    • In a patient subgroup, 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.
    • The phase 3 program is currently being planned.
    • 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. Amlitelimab’s durable efficacy 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.

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    Separately, Sanofi said lunsekimig is being explored in a broad population of asthma patients, regardless of their inflammation and severity status.

    • The readout of the AIRCULES phase 2 study in moderate to severe asthma is anticipated in 2026
    • The AIRLYMPUS phase 2 study in high-risk asthma was initiated in Q4 2024.
    • The readout of the phase 2 study in patients with chronic rhinosinusitis with nasal polyps is anticipated in 2026.
    • A phase 2/3 study in chronic obstructive pulmonary disease (COPD) will begin in 2025.

    In partnership with Regeneron Pharmaceuticals Inc (NASDAQ:REGN), two phase 3 studies were initiated so far this year.

    Itepekimab is currently being explored in COPD in two phase 3 studies, AERIFY-1 and AERIFY-2, with the readout anticipated in H2 2025, and in one phase 2 study, AERIFY-3, with the readout anticipated in H2 2025.

    Finally, itepekimab is being explored in a phase 2 study in bronchiectasis, with the readout anticipated in 2026.

    In May 2024, Sanofi reported results from the Phase 2 study of oral rilzabrutinib in adult patients with uncontrolled moderate-to-severe asthma.

    Two doses of rilzabrutinib, 800 mg daily and 1200 mg daily, were studied.

    The data showed that treatment with oral rilzabrutinib at both high and low doses led to a numerical reduction in loss of asthma control (LOAC) events (the primary endpoint) and improvements in symptoms in adult patients with uncontrolled moderate-to-severe asthma. 

    Price Action: SNY stock is down 1.33% at $51.15 at the last check Tuesday.

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    Image: Shutterstock