Sanofi has announced encouraging findings from the second part of a study with the OX40 antibody amlitelimab, which showed sustained improvement in treating moderate to severe atopic dermatitis symptoms in previously treated patients.  

In the second part of the STREAM-AD study, patients initially responding to amlitelimab were re-randomised to either continue treatment or withdraw over 28 weeks. Those continuing treatment maintained high responder rates for Eczema Area and Severity Index (EASI-75) and/or Investigator Global Assessment (IGA 0/1), as did those withdrawn from treatment – 69.2% of patients continued IGA 0/1 and/or EASI-75 response compared to 58.8% in those who had withdrawn. 

A pooled analysis showed that those who continued treatment maintained an IGA 0/1 response in 71.9% compared to 57% in the treatment-withdrawn group, with EASI-75 response maintained in 69% compared to 61.6% of patients, respectively. Atopic dermatitis-related biomarkers remained reduced at week 52 in both groups, highlighting durable control of the condition post-amlitelimab withdrawal. 

Results from this part of the study indicate amlitelimab’s potential for durable off-drug efficacy, which means less frequent dosing every 12 weeks could be evaluated, explained chair of the department of dermatology and allergy at the University Hospital Schleswig-Holstein Stephan Weidinger, in the 11 March press release.  

The 12-week dosing schedule of amlitelimab 250mg with a 500mg loading dose is now being investigated in a larger Phase III clinical program (OCEANA). 

Amlitelimab, a human anti-OX40 ligand monoclonal antibody, is under development for the treatment of atopic dermatitis, hidradenitis suppurativa, asthma, alopecia areata, celiac disease and systemic sclerosis. The antibody is forecast to generate $581m in sales by 2030, as per GlobalData analysis. 

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

GlobalData is the parent company of Clinical Trials Arena. 

Another OX40 inhibitor in the atopic dermatitis space is Amgen and Kyowa Kirin’s KHK4083 (rocatinlimab), with Amgen handling the development, production, and marketing for all worldwide markets, excluding Japan. KHK4083 is forecast to generate $960m in 2029, according to GlobalData.  

In October 2023, Astria Therapeutics signed an exclusive global agreement to license Ichnos Sciences’ OX40 portfolio to treat atopic dermatitis in a $305m deal, paying $15m upfront. The portfolio includes monoclonal antibody OX40 antagonists STAR-0310 and telazorlimab. 

Atopic dermatitis is a long-term chronic form of eczema commonly seen in people with sensitive skin and a malfunctioning immune system.  

In the announcement accompanying the data, the head of global development, immunology and inflammation at Sanofi, Naimish Patel said: “It’s unprecedented to see this type of durability of clinical response, which we believe could be very meaningful to patients and is the reason why we selected an every 12-week dosing regimen in the AD pivotal programme.”