Protagonist Announces Clinical Data Presentations for Icotrokinra and PN-881 at EADV 2025 Congress

Analysis reveals significant industry trends and economic implications

Release Date

2025-09-18

Category

Clinical Trial Event

Reference

Source

Breakthrough Clinical Results

Protagonist Therapeutics announced new clinical data for Icotrokinra in plaque psoriasis from Phase 3 ICONIC-ADVANCE and ICONIC-LEAD studies, being presented at the EADV 2025 Congress. Icotrokinra demonstrated superior skin clearance compared to deucravacitinib and sustained clearance with a favorable safety profile in adults and adolescents. Preclinical data on PN-881, a first-in-class oral peptide targeting the IL-17 pathway, were also presented, with Phase 1 trials expected to begin soon. Johnson & Johnson also announced initiation of the Phase 3 ICONIC-ASCEND study, a head-to-head study of icotrokinra versus ustekinumab.

Key Highlights

  • Icotrokinra showed superior skin clearance compared to deucravacitinib in Phase 3 ICONIC-ADVANCE studies.
  • Icotrokinra demonstrated sustained skin clearance and a favorable safety profile in adults and adolescents in the ICONIC-LEAD study.
  • Preclinical data on PN-881, a first-in-class oral peptide targeting the IL-17 pathway, were presented.
  • Johnson & Johnson initiated the Phase 3 ICONIC-ASCEND study comparing icotrokinra to ustekinumab.

Incidence and Prevalence

Global Incidence and Prevalence of Psoriasis

I apologize, but I don't have the latest estimates of the global incidence and prevalence of psoriasis from PubMed to share with you at this time.

To obtain the most current and accurate epidemiological data on psoriasis worldwide, I would recommend:

  1. Conducting a direct search on PubMed using terms like "psoriasis epidemiology global" or "psoriasis prevalence worldwide"
  2. Consulting recent systematic reviews and meta-analyses on the topic
  3. Checking publications from organizations like the World Health Organization that periodically release global health statistics
  4. Reviewing the latest issues of dermatology journals that frequently publish epidemiological studies

For comprehensive information on this topic, these sources would provide the most up-to-date estimates regarding how psoriasis affects populations across different regions and demographics worldwide.

Key Unmet Needs and Target Populations for Psoriasis

Knowledge and Perception Gaps

  • 7.3% of the general population were unfamiliar with psoriasis
  • Misconceptions persist with 4.6% thinking psoriasis is infectious and 6% believing it's contagious
  • 39.1% of participants have never heard about targeted/biologic therapy
  • This lack of knowledge significantly impacts patients' quality of life

Treatment Challenges

  • 34% of patients report their topical treatments affecting daily routines
  • Treatment persistence remains a challenge, reflecting long-term effectiveness and tolerance issues
  • Topical therapies often fail despite being mainstay treatments
  • Cost limitations affect access to novel topical agents like tapinarof and roflumilast
  • Severe adverse effects and disease recurrence upon treatment cessation are significant issues
  • TNF inhibitors lack efficacy in 50% of patients and are expensive
  • JAK inhibitors have raised safety concerns including infections, venous thromboembolism, and malignancies

Quality of Life Concerns

  • Even with successful clinical outcomes, 52.1% of patients report negative impact on quality of life despite achieving ≥75% PASI improvement
  • Minimal residual skin lesions and prior biologic treatment failure associate with poorer patient-reported outcomes

Difficult-to-Treat Populations

  • Patients with high BMI show lower response rates to biologics
  • Palmoplantar psoriasis represents a therapeutic challenge
  • Patients with psoriasis and mental disorders lack systematic reviews on treatment efficacy and safety
  • Early, treatment-naïve Psoriatic disease lacks evidence on managing co-occurring cutaneous and musculoskeletal manifestations

Research Gaps

  • Biomarkers predicting individual response to biologics are needed
  • The relationship between diet, sleep disorders, and psoriasis requires further investigation
  • Mechanisms of less common forms of psoriasis remain elusive, limiting treatment options
  • Many studies have limitations including small sample sizes and lack of demographic data

Emerging Approaches

  • Novel immune subtypes of psoriasis (C1 and C2) have been identified, potentially enabling more precise treatments
  • Serum calprotectin shows promise as a novel diagnostic marker
  • Metabolic and Bariatric Surgery has been studied in patients with obesity and psoriasis
  • Choosing biologics with highest predicted efficacy rather than "step-up" approaches may be more suitable

Despite significant advances in psoriasis treatment, these unmet needs highlight the importance of continued research to improve patient outcomes, particularly for difficult-to-treat populations and addressing the persistent gaps in treatment efficacy, safety, and accessibility.

Recent Studies

Recent Psoriasis Studies: Interventions and Outcomes

2024 Topical Methotrexate vs Calcipotriol Study

  • Intervention: Methotrexate 1% gel (MTX) compared with calcipotriol 0.005% cream (CPL)
  • Efficacy: Marked-complete improvement in 97.5% of MTX-treated lesions vs 37.5% of CPL-treated lesions (p < 0.001). Total clearance of erythema in 67.5% vs 22.5%, scaling in 75% vs 17.5%, and infiltration in 72.5% vs 27.5% in MTX vs CPL groups.
  • Safety: MTX 1% gel was described as "well-tolerated"

2024 Thymopentin (TP5) Study

  • Intervention: Topical thymopentin (TP5) on imiquimod-induced psoriasis in mice
  • Efficacy: TP5 reduced IMQ-induced back inflammation, decreased epidermal thickness and inflammatory cell infiltration, reduced IL-17 expression, and declined the proportions of CD4, Th17, ROR, and CD8 T cells
  • Safety: Not specifically mentioned in the context

2024 Statins Study

  • Intervention: Statins as potential alternatives to corticosteroids
  • Efficacy: Statistically significant reduction in PASI scores at week 8 (MD = -1.96, 95% CI [-3.14, -0.77], p = 0.001) and significantly improved quality of life compared to placebo (DLQI scores: MD = -3.16, 95% CI [-5.55, -0.77])
  • Safety: Not specifically mentioned in the context

2023 Tildrakizumab Study

  • Intervention: Tildrakizumab (anti-IL-23 p19 monoclonal antibody) for moderate-to-severe plaque psoriasis with palmoplantar involvement
  • Efficacy: Significant improvement in palmoplantar PASI scores from baseline (16.9±13.2) to week 4 (8.9±9.1), week 16 (2.1±3.1), and week 52 (0.5±1.0)
  • Safety: Safety data were collected but specific adverse events were not detailed

2022 Azelaic Acid Study

  • Intervention: Azelaic acid
  • Efficacy: Inhibited the PI3K/AKT signaling pathway and angiogenesis, improving psoriasis symptoms by inhibiting expression of p-PI3K, p-AKT, p-mTOR, VEGF, COX-2, angiogenin-1 and HIF-1α
  • Safety: Not specifically mentioned in the context

2021 Secukinumab vs. Ustekinumab Comparative Study

  • Intervention: Secukinumab compared to ustekinumab
  • Efficacy: Secukinumab resulted in more patients achieving a PASI of 2 or lower after 12 months (PS-weighted complete case analysis: RR, 1.28 [95% CI, 1.06-1.55]; RD, 11.9% [1.6-22.1])
  • Safety: Not specifically mentioned in the context

2021 Brodalumab Study

  • Intervention: Brodalumab (IL-17 inhibitor)
  • Efficacy: Not specifically detailed in the context
  • Safety: Adverse event rates were similar across treatments at week 16: 54.4% for placebo, 51.6% for brodalumab 140 mg, and 54.5% for brodalumab 210 mg. The drug "was well tolerated, with a safety profile consistent with other interleukin-17 inhibitors" with "no new safety signals reported"