JNJ-2113 (former PN-235) Statistically significantly higher proportion of adults with moderate-to-severe plaque psoriasis achieved PASI-75 at week 16 in all treatment arms compared to placebo, meeting the study’s primary endpoint Did.
Treatment was well tolerated, with no significant differences in the frequency of adverse events between treatment groups
newark, california, March 7, 2023 /PRNewswire/ — Protagonist Therapeutics, Inc. (Nasdaq: PTGX) (“Protagonist” or “Company”) today announced that Janssen Biotech, Inc. (Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen)in the FRONTIER 1 phase 2b A clinical trial evaluating the oral interleukin 23 receptor (IL-23R) antagonist peptide JNJ-2113 in patients with moderate to severe plaque psoriasis.
Data from a 255-patient study showed that JNJ-2113 met the primary efficacy endpoint of the study, with a statistically significant proportion of patients receiving JNJ-2113 and PASI-75 (75% improvement in skin lesions as measured by psoriasis area). and severity index) responses were compared to placebo at week 16 in all five treatment arms. A clear dose response was observed over an 8-fold dose range. Treatment was well tolerated, with no significant differences in the frequency of adverse events between treatment groups and placebo. Data from various preclinical and clinical studies on JNJ-2113 will be presented at the medical conference beginning in the second quarter of 2023.
“JNJ-2113 is the first and only oral IL-23 receptor antagonist in its class as a potential oral targeted therapy for psoriasis vulgaris, further underscoring the strength of our innovative peptide technology, and is at this milestone of transformation.” Full measurements of JNJ-2113 should be revealed in the FRONTIER 1 phase. 2b Data will be shared at upcoming medical conferences. Based on the strength of these data, JNJ-2113 is expected to advance to a Phase 3 registrational trial in plaque psoriasis. We are excited about the potential prospects for JNJ-2113 across a spectrum of additional IL-23-mediated diseases.” Dinesh V. PatelPh.D., President and CEO of Protagonist.
Dr. Patel continued, “This is a watershed moment for our protagonists, industry and patients due to our success in targeting the systemic immunomodulatory IL-23 monoclonal antibody pathway via an oral peptide antagonist. We believe there is, and we are humbled to be part of this important scientific breakthrough…”
JNJ-2113 clinical trial
frontier 1 phase 2b A trial (NCT05223868) was designed to evaluate the efficacy and safety of JNJ-2113 in patients with moderate to severe plaque psoriasis. This is a randomized, multicenter, double-blind, placebo-controlled study that evaluated 3 times-daily and 2-times-daily doses of JNJ-2113 taken orally in her. The trial’s primary endpoint was the proportion of patients who achieved her PASI-75 at 16 weeks.
Beyond the recently completed Phase 2b FRONTIER 1 trial and a Phase 1 trial (NCT05062200) in healthy Japanese and Chinese participants, JNJ-2113 is now being investigated in multiple trials also led by Janssen It has been. FRONTIER 2 (NCT05364554) is a long-term extension study of his JNJ-2113 in adults with moderate-to-severe plaque psoriasis. The SUMMIT Phase 2a trial (NCT05357755) is comparing delayed-release JNJ-2113 tablets to placebo in adults with moderate-to-severe plaque psoriasis. A phase 1 trial of an immediate-release formulation of JNJ-2113 in healthy Chinese adult participants (NCT05703841) is currently recruiting.
Janssen License and Collaboration Agreement
JNJ-2113 (previously known as PN-235) was discovered, License and Collaboration Agreement Between the protagonist and Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Protagonist completed her JNJ-2113 Phase 1 trial in healthy volunteers in October 2021. Janssen holds exclusive worldwide rights to develop Phase 2 and beyond and commercialize compounds derived from studies conducted pursuant to the agreement for a wide range of malignancies. signs.
About the main character
Protagonist Therapeutics is a biopharmaceutical company in advanced clinical development of novel peptide-based chemicals rusfertide and JNJ-2113 (formerly PN-235), both derived from its proprietary technology platform. increase. Rasfertide, a mimetic of the natural hormone hepcidin, is our lead drug candidate currently in Phase 3 development worldwide. The Phase 3 VERIFY and Phase 2 REVIVE trials of rusfertide in polycythemia vera are ongoing. The main character retains all worldwide development and commercialization rights to Rasfertid.
If JNJ-2113 progresses to a Phase 3 trial and the trial meets its primary endpoint, the lead will be eligible for the next milestone payment. $50 million and $115 million, Each.In total, the hero has the maximum $855 million With various milestone payments and tiered royalties based on global pharmaceutical net sales.
Cautionary Note Regarding 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. -2113 (formerly his PN-235), receipt of milestones and other payments under licensing and collaboration agreements with Janssen, and commercial potential of JNJ-2113. In some cases, these statements use forward-looking words such as “expect,” “believe,” “may,” “will,” and “expect,” or negative forms of these words. It can be identified by its plural form or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results or events to differ materially from expectations. Acquisition of milestone payments under collaboration agreement with Janssen Biotech; impact of current COVID-19 pandemic on discovery and development efforts; ability to use and expand program to build pipeline of product candidates; Ability to maintain regulatory approval of product candidates, ability to operate in a highly competitive industry and compete successfully against competitors with more resources than ours, and to obtain and properly secure intellectual property rights in product candidates Ability to protect. Additional information regarding these and other risk factors affecting our business can be found in the securities trading, including under the heading “Risk Factors,” contained in our recently filed periodic reports on Forms 10-K and 10-K. It is documented in regular submissions to the Commission. Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and developments in the industries in which we operate, may affect the forward-looking statements contained in this press release. It may differ significantly from the description. Forward-looking statements in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this press release.
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