Sanofi: amlitelimab met phase 3 primary endpoints

Sanofi: amlitelimab met phase 3 primary endpoints

Sanofi has announced that its investigational drug, amlitelimab, has met its primary endpoints in a phase 3 clinical trial. The drug is a fully human, non-T cell depleting monoclonal antibody that blocks OX40L, a key immune regulator. The trial, known as STREAM-AD, evaluated the maintenance of treatment response with amlitelimab in moderate-to-severe atopic dermatitis (AD) over a period of 52 weeks.

The results of the trial have not been officially disclosed, but the announcement from Sanofi indicates that the drug has demonstrated significant clinical benefits in the treatment of moderate-to-severe AD. The trial's primary endpoint was likely the percentage of patients achieving a specific level of improvement in their AD symptoms, as measured by a validated scoring system.

Sanofi's Global Therapeutic Area Head, Immunology and Oncology Development, Alyssa Johnsen, MD, PhD, commented on the milestone, stating, "Our data from the STREAM-AD trial builds on the growing body of evidence for amlitelimab's potential to improve outcomes for patients with moderate-to-severe atopic dermatitis. This is a significant step forward in our efforts to advance transformative therapies for chronic inflammatory skin diseases."

The success of amlitelimab in meeting its primary endpoints is a promising development for Sanofi and the broader field of immunology. The drug's unique mechanism of action, which aims to normalize the overactive immune system without depleting T cells, could make it a first- or best-in-class treatment for a range of immune-mediated diseases and inflammatory disorders.

Sanofi is expected to present the full results of the STREAM-AD trial at the upcoming European Academy of Dermatology and Venereology (EADV) Congress in Paris, France, from September 17 to 20, 2025. The company will also be showcasing data from other studies, including those evaluating brivekimig in hidradenitis suppurativa and Dupixent across various inflammatory skin diseases.

The potential success of amlitelimab could have a significant impact on Sanofi's financial performance, as it expands the company's pipeline of therapies for chronic inflammatory skin diseases. Investors will be closely watching the upcoming EADV Congress to learn more about the results of these trials and the potential for amlitelimab and other Sanofi drugs to advance to market.

References:
[1] https://www.webwire.com/ViewPressRel.asp?aId=343325
[2] https://www.marketscreener.com/news/impact-of-obicetrapib-on-major-adverse-cardiovascular-events-a-pooled-analysis-of-phase-3-clinical-ce7c50d2dc8ef521