India's central drug regulatory authority has given Sanofi Healthcare India the green light to proceed with an extended evaluation of amlitelimab, marking a significant step forward in the development of innovative treatments for atopic dermatitis.
The Subject Expert Committee (SEC) under the Central Drug Standard Control Organisation (CDSCO) approved the company's proposal to conduct a Phase II/III long-term extension study following their meeting on January 16, 2025. The study, identified as protocol number LTS17367 (amendment 05, version 1), will focus on adult patients with moderate to severe atopic dermatitis.
Novel Mechanism of Action
Amlitelimab (SAR445229) represents an innovative approach to treating inflammatory skin conditions. As a fully human, non-cytotoxic, non-depleting IgG4 monoclonal antibody, it specifically targets the OX40 ligand (OX40L) on antigen-presenting cells. This mechanism offers a new strategy for modulating persistent inflammation associated with atopic dermatitis.
Study Design and Objectives
The approved clinical trial will evaluate three key aspects:
- Long-term safety profile of subcutaneous amlitelimab
- Overall tolerability in the target patient population
- Sustained efficacy in managing moderate to severe atopic dermatitis
Addressing Unmet Medical Needs
Atopic dermatitis remains a challenging inflammatory skin condition with substantial unmet therapeutic needs. The development of amlitelimab represents a targeted approach to disease management by interrupting the OX40-OX40L costimulation pathway, potentially offering relief to patients who have limited treatment options.
The SEC's recommendation for trial approval came after thorough deliberation of the study protocol, reflecting the committee's confidence in the scientific merit and potential therapeutic value of this investigational treatment.
