J&J’s Janssen unveils results of “first and only antagonist peptide” treating severe plaque psoriasis
05 Jul 2023 --- Janssen Pharmaceutical Companies has achieved positive results from testing the novel oral interleukin-23 receptor (IL-23R) antagonist peptide JNJ-2113 in adult patients with moderate-to-severe plaque psoriasis. The immune-mediated disease causes skin cell overproduction, causing painful and itchy plaques.
In the Phase 2b Frontier 1 clinical trial, the antagonist peptide achieved all primary and secondary efficacy endpoints.
Compared to the placebo, at week 16.1, a more significant proportion of patients who received JNJ-2113 achieved PASI 75, PASI 90 and PASI 100 – meaning 75, 90 and 100% improvement in skin lesions as measured by the Psoriasis Area and Severity Index.
The trial supports the advancement of the treatment into Phase 3 clinical development.
According to research cited by Janssen, 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 psoriasis have cases considered moderate-to-severe.”
Pill function
Plaque psoriasis disease impacts health, emotional health, relationships and life stress.
“Patients are looking for more flexible and convenient treatment options to manage the signs and symptoms of psoriasis, and these positive early results for JNJ-2113 are encouraging,” says Robert Bissonnette, M.D., FRCPC, CEO and medical director at Innovaderm, Canada and lead investigator of the Frontier clinical trial.
This trial supports the advancement of the treatment into Phase 3 clinical development.
“The majority of people living with moderate-to-severe plaque psoriasis are eligible for but are still not receiving advanced therapies. For many patients, a pill is preferable to an injection.”
JNJ-2113 binds with the IL-23R and has properties that allow it to be absorbed with oral dosing.
“IL-23/IL-23R signaling pathway plays a critical role in the pathogenesis of immune-mediated inflammatory diseases, including psoriasis. JNJ-2113 selectively and potently blocks IL-23 signaling and downstream inflammatory cytokine production,” explains Janssen.
Changing the paradigm
According to the researchers, the treatment was “well tolerated” among the 212 patients. The proportions of patients with adverse events were comparable between patient groups. “The proportion of participants experiencing one or more adverse events was 52.4% (111) in the combined JNJ-2113 group and 51.2% (22) in the placebo group,” shares Janssen.
“The development of a novel oral therapy that specifically targets IL-23R could potentially change the treatment paradigm for patients living with moderate-to-severe plaque psoriasis,” comments Lloyd Miller, M.D., Ph.D., VP of immunodermatology disease area stronghold leader at Janssen R&D.
“Until now, advanced psoriasis treatments have been largely limited to injectable biologics. An oral therapy that can uniquely inhibit the IL-23 pathway by directly targeting the IL-23 receptor could help address the needs and preferences of patients and may offer greater freedom, to drive greater adoption of advanced treatment.”
In related developments, SkinBioTherapeutics received approval from Italian regulators to issue AxisBiotix-Ps, a food supplement to alleviate the symptoms associated with psoriasis, onto the nation’s market.
Arctiva developed a steroid-free psoriasis cream, which showed that 92% of users experienced calmer, more moisturized skin and significantly reduced psoriasis symptoms after using the cream.
By Venya Patel
