Janssen Pharmaceuticals recently announced its latest clinical trial results of JNJ-2113, the novel, first-in-class oral interleukin 23 receptor (IL-23R) antagonist peptide in adult patients with moderate-to-severe plaque psoriasis (PsO). Representing an innovative oral therapy that specifically targets and binds with high affinity to the IL-23R, JNJ-2113 is set to become a leading treatment for this debilitating, chronic condition, with a global sales forecast of $292 million by 2029, according to GlobalData.
Mariam Shwea, Healthcare Analyst at GlobalData, comments, “JNJ-2113 is welcomed for its trailblazing nature, as the reported Phase IIb data demonstrated complete clearance and improvement in skin lesions in the participants when compared to the respective placebo groups, indicating the potential of the agent to transform the treatment landscape for PsO.”
The efficacy of JNJ-2113 for PsO was reinforced by the results of Johnson & Johnson’s (J&J) randomised, multicenter, double-blind, placebo-controlled, 24-week long Phase IIb FRONTIER 1 (NCT05223868) clinical trial, which evaluated three once-daily dosages and two twice-daily dosages of the agent taken orally by patients with moderate-to-severe plaque PsO, which form the basis for the agent’s progression to Phase III development.
Results indicated the proportion of patients who achieved Psoriasis Area and Severity Index (PASI) 75 was 9.3 per cent for the placebo group, and 37.2 per cent, 58.1 per cent, 51.2 per cent, 65.1 per cent, and 78.6 per cent for the JNJ-2113 groups at week 16, respectively. Similarly, the proportion of patients who achieved PASI 90 was 2.3 per cent for the placebo group, and 25.6 per cent, 51.2 per cent, 26.8 per cent, 46.5 per cent, and 59.5 per cent for the treatment groups at week 16, respectively, demonstrating dose-dependent responses across primary and secondary endpoints.
Shwea adds, “By selectively blocking IL-23/IL-23R signaling and the production of inflammatory cytokines downstream, JNJ-2113 offers a distinctive and effective approach to managing PsO. The promising results of the flexible and convenient agent signify the potential impact of JNJ-2113 on the treatment paradigm for moderate-to-severe PsO. As an oral agent, it may have a higher PASI 75 response than Bristol Myers Squibb’s Sotytku (deucravacitinib), another IL-23R antagonist. However, indirect comparisons should be made with caution due to differences in clinical trial designs and patient populations.”
JNJ-2113 was generally well tolerated by the treatment groups, with no evidence of a dose-dependent increase in specific adverse events. The most frequent system organ class affected by adverse events in both treatment and placebo arms was infections and infestations, with the most common cases being COVID-19, nasopharyngitis, and upper respiratory tract infections.
Shwea concludes, “With advanced psoriasis treatments having largely been limited to injectable biologics, the data presented by J&J underlines the ability and potential of JNJ-2113 to offer an opportunity to address patient needs and preferences by providing an oral therapy that directly targets the IL-23 pathway. This may bring about greater treatment adoption and consequently improve patient outcomes.”