Sanofi’s amlitelimab shows best-in-class response in atopic dermatitis
2024-03-11
临床3期临床结果引进/卖出
Preview
来源: Pharmaceutical Technology
Sanofi’s investigational drug amlitelimab is forecast to generate $581m in sales by 2030, as per GlobalData analysis. Credit: Golden Shrimp via Shutterstock.
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rates for Eczema Area and Severity Index (EASI-75) and/or Investigator Global Assessment (IGA 0/1), as did those withdrawn from treatment – 69.2% of patients continued IGA 0/1 and/or EASI-75 response compared to 58.8% in those who had withdrawn.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showed that those who continued treatment maintained an IGA 0/1 response in 71.9% compared to 57% in the treatment-withdrawn group, with EASI-75 response maintained in 69% compared to 61.6% of patients, respectively.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).
See Also:
Preview
来源: Pharmaceutical Technology
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.
GlobalData is the parent company of Clinical Trials Arena.
Another OX40 inhibitorOX40 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.”
更多内容，请访问原始网站
文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。
靶点
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。