Protagonist Therapeutics Receives $165M Milestone Payment Following Positive Phase 3 Results for Oral IL-23 Inhibitor Icotrokinra in Psoriasis
Protagonist Therapeutics
Developer of Novel Therapies
Johnson & Johnson
Healthcare Product Manufacturers, Health Service Providers
On November 19, Johnson & Johnson and Protagonist Therapeutics jointly announced,Icotrokinra (JNJ-2113，Previously known as PN-235) Key Phase 3 ICONIC Study Achieves Positive Topline Results. This Phase 3 study met the co-primary endpoints of Psoriasis Area and Severity Index (PASI) 90 and Investigator Global Assessment (IGA) 0/1 response at Week 16, and the response rate continued to improve through Week 24.
According to its press release,JNJ-2113Is the first targeted oral peptide that selectively blocks the IL-23 receptor, indicated for adults and adolescents aged 12 years and older with moderate to severe plaque psoriasis (PsO).。
Once daily, compared with placeboicotrokinraDemonstrated significant skin clearance in adults and adolescents with moderate to severe plaque psoriasis.
At week 16, nearly two-thirds (64.7%) of patients treated with ektinib achieved an IGA score of 0/1 (clear or almost clear skin), and 49.6% achieved PASI90, compared to 8.3% and 4.4% in the placebo group, respectively.ICONIC-TOTAL Achieved the Primary Endpoint of IGA Score 0 or 1 at Week 16 in Patients with Refractory Plaque Psoriasis. At Week 24, the response rate continued to increase further, reaching 74.1%.icotrokinraTreat patients to achieve 0/1 point, 64.9% of patients achieved PASI90.
Safety data were consistent with those from the Phase 2 FRONTIER 1 and 2 studies.icotrokinraThe proportion of patients experiencing adverse events (AE) between the treatment and placebo groups was similar, with 49.3% and 49.1% of participants reporting treatment-emergent adverse events (TEAE) by Week 16.
The combined results of ICONIC-LEAD and ICONIC-TOTAL are being prepared for presentation at an upcoming medical conference.
Other studies in the ICONIC Phase 3 clinical development program are ongoing, including ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2, which will evaluate the safety and efficacy of icotrokinra compared to placebo and deucravacitinib in moderate to severe plaque psoriasis.ICONIC-PsA Phase 3 Program to Launch in Early 2025, the Project WillStudy on the Therapeutic Effect of Icotrokinra in Psoriatic Arthritis。
JNJ-2113 is an orally administered peptide IL-23 receptor antagonist. The IL-23/IL-23R signaling pathway plays a crucial role in the pathogenesis of immune-mediated inflammatory diseases, including psoriasis, psoriatic arthritis, and inflammatory bowel disease.
In 2017,Janssen Spent $980 Million to Reach an Agreement with Protagonist Therapeutics,Advance TogetherAdvanceOral IL-23 Receptor AntagonistDrug DevelopmentIn December 2021, Protagonist and Janssen decided to designate PN-235 as the candidate drug.
According to a press release from Protagonist Therapeutics, Inc., asPhase 3 ICONIC Study Achieves Positive Results，The company has obtained Johnson & Johnson's$165 millionMilestone Payment。In addition, Protagonist is still eligible to receive up to $630 million in future development and sales milestone payments, as well as tiered royalties of 6-10% on global net sales.
Vice President of Johnson & Johnson Innovation MedicineLiza O'Dowd, Head of Immunodermatology, expressed: "We are very pleased to see the progress made with once-daily icotrokinra treatment."PositiveThe phase 3 results are consistent with our phase 2 study of this first-in-class oral targeted peptide that selectively blocks the IL-23 receptor. Most patients with moderate to severe plaque psoriasis are eligible for advanced therapies but remain untreated. Icotrokinra has the potential to provide a once-daily oral therapy, which could help meet the needs and preferences of patients with plaque psoriasis."
"These positive Phase 3 study results confirm the compelling efficacy and safety trends observed in the previous Phase 2b FRONTIER-1 and -2 studies, highlighting the potential of icotrokinra as a best-in-class oral therapy. It is an ideal oral treatment for plaque psoriasis with significant skin clearance and excellent tolerability, taken once daily," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer of Protagonist Therapeutics.
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