Plaque psoriasis oral therapy moves to phase 3 trial, being tested in other conditions

Key takeaways:

• JNJ-2113 is an oral interleukin-23 receptor antagonist peptide being tested to treat moderate to severe plaque psoriasis.
• More patients treated with JNJ-2113 vs. placebo met primary and secondary endpoints.

An oral interleukin-23 receptor antagonist peptide for adults with moderate to severe plaque psoriasis, JNJ-2113, met all endpoints in an efficacy trial and is now advancing to phase 3, according to a press release.

JNJ-2113 “selectively and potently blocks” interleukin-23 (IL-23) signaling in human T cells, which has an important role in plaque psoriasis and other immune-mediated inflammatory diseases, and downstream inflammatory cytokine production, Janssen Pharmaceutical Companies and Johnson & Johnson announced in the release.

The drug, described in the release as the “first and only oral” therapy of its kind, is also being studied in other conditions.

The treatment “could potentially change the treatment paradigm” for patients with the condition, which can usually only be treated with injectable biologics in advanced cases, Lloyd S. Miller, MD, PhD, Janssen Pharmaceutical Companies of Johnson & Johnson vice president and immunodermatology disease area stronghold leader, said in the release.

“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, with the aim of driving greater adoption of advanced treatment,” Miller said.

The primary endpoint of a 75% improvement in skin lesions as measured by PASI was achieved by 212 patients in the JNJ-2113 group compared with 43 in the placebo group at week 16 of FRONTIER 1, a phase 2b, randomized, multicenter, double-blind, placebo-controlled clinical trial, according to the release.

A greater proportion of patients receiving JNJ-2113 also met the secondary endpoints of 90% (P .002) and 100% (P .05) improvements in PASI scores.

Patients generally tolerated the treatment well, according to the release, with comparable proportions of patients with adverse events between the groups.

According to the release, these results suggest that JNJ-2113 could have benefits “across the spectrum of IL-23-mediated diseases.” Janssen will now move JNJ-2113 into phase 3 development for plaque psoriasis, and a phase 2b trial of JNJ-2113 is also planned for adults with ulcerative colitis.