Icotrokinra shows impressive results in moderate to severe plaque psoriasis in phase 3 trial

Icotrokinra is an investigational oral peptide that blocks interleukin (IL)-23 receptor, which plays a significant role in the pathogenesis of moderate to severe plaque Psoriasis and other IL-23 mediated diseases.

Topline results from a phase 3 trial evaluating icotrokinra in patients with moderate to severe plaque psoriasis (PsO) has revealed impressive results.

The Phase 3 study met its co-primary endpoints of Psoriasis Area and Severity Index (PASI) 90b and Investigator's Global Assessment (IGA) of 0/1c response at week 16 and response rates continued to improve through week 24.

Once daily icotrokinra showed significant skin clearance versus placebo in adults and adolescents with moderate to severe plaque psoriasis. At week 16, nearly two-thirds (64.7%) of patients treated with icotrokinra achieved IGA scores of 0/1 (clear or almost clear skin), and 49.6% achieved PASI 90, compared to 8.3% and 4.4% on placebo, respectively. Further increases in response rates continued to be observed at week 24, with 74.1% of patients treated with icotrokinra achieving IGA scores of 0/1, and 64.9% achieving PASI 90.1 Safety data was found to be consistent with the Phase 2 FRONTIER 1 and 2 studies. A similar proportion of patients experienced adverse events (AEs) between icotrokinra and placebo, with 49.3% and 49.1% of participants experiencing a treatment emergent adverse event (TEAE) at week 16.

Furthermore, positive topline results from the Phase 3 ICONIC-TOTALd study showed once daily icotrokinra met the primary endpoint of IGA of 0/1 at week 16 compared to placebo. Comprehensive results from ICONIC-LEAD and ICONIC-TOTAL are being prepared for presentation at upcoming medical congresses and will be shared with health authorities in planned submissions.

"We are excited to see impressive Phase 3 results with once-daily icotrokinra treatment aligned with our Phase 2 study of this first-in-class targeted oral peptide that selectively blocks the IL-23 receptor," said Liza O'Dowd, Vice President, Immunodermatology Disease Area Lead, Johnson & Johnson Innovative Medicine. "The majority of people living with moderate to severe plaque psoriasis are eligible for, but are still not receiving, advanced therapies. Icotrokinra has the potential to offer once-daily oral therapy that could help address the needs and preferences of people living with plaque psoriasis."

Other studies in the Phase 3 ICONIC clinical development program are ongoing, including ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2, which will evaluate the safety and efficacy of icotrokinra compared with both placebo and deucravacitinib in moderate to severe plaque PsO. The Phase 3 ICONIC-PsA program which will investigate icotrokinra in psoriatic arthritis will be initiated in the beginning of 2025.

About Plaque Psoriasis

Plaque psoriasis (PsO) is a chronic immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful. It is estimated that eight million Americans and more than 125 million people worldwide live with the disease.Nearly one-quarter of all people with plaque PsO have cases that are considered moderate to severe. On Caucasian skin, plaques typically appear as raised, red patches covered with a silvery white buildup of dead skin cells or scale. On skin of color, the plaques may appear darker and thicker and more of a purple, gray or dark brown color. Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso. Living with plaque PsO can be a challenge and impact life beyond a person's physical health, including emotional health, relationships, and handling the stressors of life. Psoriasis on highly visible areas of the body or sensitive skin, such as the scalp, hands, feet, and genitals, can have an increased negative impact on quality of life.

About Icotrokinra (JNJ-77242113, JNJ-2113)

Investigational icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor, which underpins the inflammatory response in moderate to severe plaque PsO and other IL-23-mediated diseases. Icotrokinra binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, selective inhibition of IL-23 signaling in human T cells. The license and collaboration agreement established between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., in 2017 enabled the companies to work together to discover and develop next-generation compounds that ultimately led to icotrokinra. Icotrokinra was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. Johnson & Johnson retains exclusive worldwide rights to develop icotrokinra in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications.