Data from the 255-patient study showed that JNJ-2113 achieved the study's primary efficacy endpoint, with a statistically significant greater proportion of patients who received JNJ-2113 achieving PASI-75 (a 75% improvement in skin lesions as measured by the Psoriasis Area and Severity Index) responses compared to placebo at Week 16 in all five treatment groups. A clear dose response was observed across an eight-fold dose range. Treatment was well tolerated, with no meaningful difference in frequency of adverse events across treatment groups versus placebo. Data will be presented from various pre-clinical and clinical studies on JNJ-2113 at medical conferences beginning in the second quarter of 2023.
'We are thrilled to be at this transformative junction, with JNJ-2113 being the first- and only-in-class oral IL-23 receptor antagonist as a potential oral targeted therapy for plaque psoriasis, further underscoring the strength of our innovative peptide technology platform. A full measure of JNJ-2113 should be evident when the FRONTIER 1 Phase 2b data are shared at an upcoming medical conference. It is our expectation that JNJ-2113 will progress into a Phase 3 registrational study in plaque psoriasis on the strength of these data. We are excited about JNJ-2113's potential prospects across the spectrum of additional IL-23 mediated diseases,' said
JNJ-2113 Clinical Trials
The FRONTIER 1 Phase 2b trial (NCT05223868) was designed to assess the efficacy and safety of JNJ-2113 in patients with moderate-to-severe plaque psoriasis. It is a randomized, multicenter, double-blind, placebo-controlled study that evaluated three once-daily dosages and two twice-daily dosages of JNJ-2113 taken orally. The primary endpoint of the study is the proportion of patients achieving PASI-75 at 16 weeks.
Beyond the recently completed Phase 2b FRONTIER 1 study and a Phase 1 trial (NCT05062200) in healthy Japanese and Chinese participants, JNJ-2113 is currently being studied in multiple trials, also led by Janssen. 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 versus 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.
Janssen License and Collaboration Agreement
JNJ-2113 (formerly known as PN-235) was discovered and is being developed pursuant to the license and collaboration agreement between
About Protagonist
Advancement of JNJ-2113 into a Phase 3 study and meeting the primary endpoint in that study would qualify Protagonist for milestone payments of
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, our expectations regarding Janssen's development of JNJ-2113 (formerly PN-235), our receipt of milestones and other payments under our license and collaboration agreement with Janssen, and the commercial potential of JNJ-2113. In some cases, you can identify these statements by forward-looking words such as 'anticipate,' 'believe,' 'may,' 'will,' 'expect,' or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreement with
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