Johnson & Johnson(JNJ) 'ICOTYDE' 52-week clinical trial complete remission rate reaches 49%... Shaking up the oral treatment drug market landscape

Johnson & Johnson (JNJ) has released one-year clinical data for its psoriasis treatment drug ‘ICOTYDE’, shaking up the oral treatment market landscape. The large-scale Phase 3 results for patients with moderate to severe plaque psoriasis confirm its long-term complete skin clearance effect along with stable safety, attracting industry attention.

On the 28th local time, Johnson & Johnson (JNJ) announced the 52-week clinical trial results for ‘ICOTYDE’ (ingredient name: Icotinib) at the American Academy of Dermatology (AAD) annual meeting. This study is based on late-stage clinical projects such as ICONIC-ADVANCE 1, 2, and ICONIC-LEAD. ICOTYDE is the first oral peptide drug that precisely blocks the IL-23 receptor.

‘ICOTYDE’ maintained a high level of complete skin clearance effect at the 52-week time point. The primary endpoint, PASI 100 complete clearance rate, increased from 41% at week 24 to 49% at week 52 in the ADVANCE 1 study, and from 33% to 48% in the ADVANCE 2 study. Patients who switched from the placebo group showed similar improvement rates of 50% and 43% at week 52, respectively. No new adverse reaction signals were found in terms of safety, consistent with the previous data at 16 and 24 weeks.

The effect of ‘ICOTYDE’ is particularly prominent in the adolescent patient population. According to the ICONIC-LEAD study, approximately 57% of patients achieved PASI 100 at 52 weeks, and 61% achieved complete skin clearance based on the IGA 0 standard. The PASI 90 response rate reached 86%, with 92% maintaining the response after 24 weeks. The incidence of adverse events did not increase over the year.

Dr. Linda Stein Gold from Henry Ford Health Center commented, “As a once-daily oral therapy, ‘ICOTYDE’ presents a new option that combines efficacy and safety. Long-term data indicate significant progress in chronic disease management.” Dr. Jennifer Song of Southern California Dermatology also emphasized, “This is a ‘breakthrough’ therapy confirmed to have sustained effects across all age groups, including adolescents.”

Johnson & Johnson’s head of Immunology Dermatology, Lisa O’Dowd, stated, “These results indicate that ‘ICOTYDE’ has the potential to become a first-line systemic therapy, capable of instigating substantial change in the plaque psoriasis market, where treatment gaps exist.”

Plaque psoriasis is a chronic immune disease affecting over 125 million patients globally, characterized by inflammation and scaling due to excessive proliferation of skin cells. About 25% of patients are classified as moderate to severe, significantly impacting their quality of life. The industry has noted that in an injection-centered treatment environment, the demand for ‘effective oral therapies’ is rapidly increasing, leading to interest in 'ICOTYDE’s market expansion potential.

Comment: Oral immunological disease treatment drugs are highly competitive in terms of convenience and compliance. This data indicates that ‘ICOTYDE’ has the potential to reshape the existing injection-dominated market landscape.