Sanofi's Amlitelimab Study: Long-term Safety and Efficacy in Atopic Dermatitis Treatment

Sanofi's study on amlitelimab, a treatment for moderate to severe atopic dermatitis, is ongoing. The long-term extension study aims to assess the safety and efficacy of amlitelimab in participants from previous trials. The study is recruiting participants and began on August 22, 2022, with the last update submitted on July 8, 2025. Positive results could enhance Sanofi's market position in dermatological treatments and impact its stock performance.

Sanofi SA (SNY) has recently announced an update on its ongoing clinical study, a long-term extension study titled "A Long-term Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Amlitelimab in Participants of Previous Amlitelimab Clinical Trials in Moderate to Severe Atopic Dermatitis" [1]. The study aims to assess the long-term safety and efficacy of amlitelimab, an investigational drug designed to treat moderate to severe atopic dermatitis. The study began on August 22, 2022, and is currently recruiting participants, with the last update submitted on July 8, 2025 [1].

Amlitelimab is administered via subcutaneous injection and is being evaluated in conjunction with other treatments such as topical corticosteroids, topical calcineurin inhibitors, and oral corticosteroids. The study follows a single-group assignment model with no masking, focusing on treatment as its primary purpose. Participants will receive regular visits every four weeks, with some allowed remote or home dosing. The study includes both responder and non-responder participants from previous trials, with specific protocols for drug withdrawal and treatment restoration based on response [1].

The study's findings could significantly impact Sanofi's market position in dermatological treatments. Positive results may enhance the company's competitive standing in the pharmaceutical industry, potentially influencing stock performance and investor sentiment. Investors should closely monitor this study's outcomes, as they could provide valuable insights into the long-term effects and potential benefits of amlitelimab for patients with atopic dermatitis [1].

In a related development, Apogee Therapeutics announced that its experimental antibody drug APG777 significantly reduced signs and symptoms of atopic dermatitis when compared to a placebo in a mid-stage trial [2]. The drug showed promising results, with 67% of participants achieving 75% skin clearance compared to 25% on placebo. This performance is considered competitive with approved treatments like Dupixent and Ebgylss. The study's findings suggest that APG777 could offer a less frequent dosing advantage, potentially transforming the standard of care for atopic dermatitis [2].

These developments highlight the ongoing advancements in the treatment of atopic dermatitis, a chronic skin condition that affects millions of people worldwide. Both Sanofi's long-term study on amlitelimab and Apogee Therapeutics' APG777 show promise in providing more effective and convenient treatment options for patients.

References:
[1] https://www.tipranks.com/news/company-announcements/sanofis-amlitelimab-study-long-term-safety-and-efficacy-in-atopic-dermatitis
[2] https://www.biopharmadive.com/news/apogee-atopic-dermatitis-antibody-results-dupixent/752306/