FDA Approves Icotrokinra (Icotyde), the First Oral IL-23 Receptor Antagonist, for Moderate-to-Severe Plaque Psoriasis

Plaque psoriasis is an immune-mediated condition that leads to excessive skin cell production, resulting in inflamed, scaly plaques that may be itchy or painful.It is estimated that more than 125 million people worldwide suffer from the disease, and nearly a quarter of patients with plaque psoriasis have moderate to severe cases.Plaque psoriasis not only affects physical health but also becomes a source of stress for emotional well-being, interpersonal relationships, and daily life, especially when lesions appear on visible or sensitive areas, significantly impacting the patient's physical comfort and quality of life. For many patients with moderate to severe conditions, targeted systemic treatment is crucial. This is also consistent with the recommendations of the International Psoriasis Council, which advises considering systemic treatment if significant improvement is not achieved after two consecutive cycles (each cycle lasting 4 weeks) of topical medication.

This approval is based on the evidence accumulated from the ICONIC clinical development program, which conducted evaluations in both adult and adolescent populations, covering psoriasis on high-impact areas such as the scalp and genitals. It also includes several head-to-head comparative trials with active control drugs.In four Phase 3 clinical studies covering approximately 2,500 patients, Icotyde met all primary efficacy endpoints.And demonstrated good safety characteristics. In the superiority head-to-head study,Approximately 70% of patients achieved clear or almost clear skin lesions (IGA 0/1) by week 16, and 55% of patients reached a Psoriasis Area and Severity Index (PASI) 90 response.By week 16, the incidence of adverse reactions in the Icotyde treatment group was within 1.1% of that in the placebo group, and no new safety signals were identified by week 52.

Icotyde is a "first-in-class" targeted oral peptide that can selectively block the IL-23 receptor (IL-23R).IL-23 plays a key role in the pathogenic T cell activation in moderate to severe plaque PsO and is fundamental to the inflammatory response in PsO and other dermatological, rheumatological, and IL-23-mediated gastrointestinal diseases. Icotyde can bind to IL-23R with single-digit picomolar affinity and exerts potent selective inhibition of IL-23 signaling in human T cells.