Protagonist Therapeutics announced today the positive topline results of its FRONTIER 1 phase 2b clinical trial (NCT05223868) investigating JNJ-2113, an oral interleukin (IL) -23 receptor antagonist peptide developed in collaboration with Janssen Biotech, Inc., for the treatment of patients with moderate-to-severe plaque psoriasis.1 JNJ-2113 met the primary study endpoint of a statistically greater proportion of adult patients achieving a 75% improvement in skin lesions measured by the Psoriasis Area and Severity Index (PASI) scores compared to placebo at week 16 across 5 total treatment groups.
Out of 255 patients, treatment with JNJ-2113 was well tolerated with no significant difference in the frequency of adverse events among the 5 treatment groups compared to placebo. Additionally, a clear dose response was seen across an 8-fold dose range. A few secondary endpoints of FRONTIER 1 include a change from baseline in PASI total scores at week 16, the percentage of patients achieving PASI 90 at week 16, and the percentage of patients achieving an Investigator's Global Assessment score of cleared (0) or minimal (1) at week 16.2
Protagonist Therapeutics noted that data from pre-clinical and clinical trials on JNJ-2113 will be presented at various medical meetings in Q2 2023.
FRONTIER 1 evaluated the safety and efficacy of JNJ-2113 in patients with moderate-to-severe plaque psoriasis. The randomized, multicenter, double-blind, placebo-controlled study investigated 3 once-daily doses and 2 twice-daily doses of oral JNJ-2113. As progress continues, FRONTIER 2 (NCT05364554) is a long-term extension study of JNJ-2113 in adults with moderate-to-severe plaque psoriasis, the SUMMIT phase 2a trial (NCT05357755) is testing a delayed release JNJ-2113 tablet compared to placebo in adults with moderate-to-severe plaque psoriasis, and a phase 1 trial (NCT05703841) of an immediate release formulation of JNJ-2113 in healthy Chinese adult participants is currently recruiting patients.
JNJ-2113, previously known as PN-235, “was discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson.” Protagonist Therapeutics initially completed a phase 1 study of JNJ-2113 in health participants in October 2021, and Janssen now retains exclude, worldwide rights to develop in phase 2 and beyond.1