PN-232 / Protagonist Therap, J&J - LARVOL DELTA

PN232. Demystifying the Perioperative Management of Pacemakers and ICDs (ASA 2024) - "Learning Objective 1 Describe the current recommendations for perioperative CIED management for cases in the operating room and for out-of-OR procedures Learning Objective 2 Use a decision-making algorithm to formulate and implement an appropriate plan for perioperative CIED management . Learning Objective 3 Assist colleagues with perioperative CIED management and decision-making in their home institutions"

Cognitive Disorders

Protagonist Reports First Quarter 2023 Financial Results and Provides Corporate Update (PRNewswire) - "Research and Development ('R&D') Expenses: R&D expenses for the first quarter of 2023 were $27.4 million, as compared to $36.3 million for the first quarter of 2022. The decrease in R&D expenses from prior year quarter was primarily due to decreases in PN-943 expenses and costs related to the completion of JNJ-2113 and PN-232 Phase 1 trials, partially offset by an increase in rusfertide expenses related primarily to the Phase 3 VERIFY clinical trial. We do not intend to dedicate further internal resources to clinical development or contract manufacturing activities for our PN-943 clinical program."

Commercial • Immunology • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis

PN232. Rural Anesthesia care:The Disparity in global anesthesia care: what we learn from a large developing country (ASA 2023) - "However, disparities in anesthesia care still exist within these countries, particularly in rural and remote areas. In this session we will discuss the disparity in global anesthesia care and share the challenge encountered and possible solutions drawn from the experience of China, the United States and Brazil."

Clinical • Anesthesia • Developmental Disorders

Pharmacokinetics of PN-232 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Protagonist Therapeutics, Inc. | Active, not recruiting ➔ Completed | N=84 ➔ 48 | Trial primary completion date: May 2022 ➔ Dec 2021

Enrollment change • Trial completion • Trial primary completion date

PN232. Challenges and Controversies in Trauma Management (ASA 2022) - "Critically evaluate the current literature on perioperative care of trauma patients. Assess how new trends in trauma management impact anesthesia care."

Anesthesia • Genetic Disorders • Obesity

A Study of JNJ-75105186 in Healthy Japanese and Chinese Participants (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Janssen Pharmaceutical K.K. | N=32 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal

Pharmacokinetics of PN-232 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=84 | Active, not recruiting | Sponsor: Protagonist Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2021 ➔ May 2022

Enrollment closed • Trial primary completion date

A Study of JNJ-75105186 in Healthy Japanese and Chinese Participants (clinicaltrials.gov) - P1; N=32; Recruiting; Sponsor: Janssen Pharmaceutical K.K.

Clinical • New P1 trial

Protagonist Therapeutics Reports Third Quarter 2021 Financial Results and Provides Corporate Update (PRNewswire) - "PN-235 moves into a psoriasis indication, Phase 2 study initiation planned for early 2022...Following a pre-specified interim analysis criteria, a portfolio decision was made to stop further development of the first-generation IL-23 receptor antagonist (IL-23R) candidate PTG-200 (JNJ-67864238), in favor of continued development of the two second generation candidates PN-235 (JNJ-77242113) and PN-232 (JNJ-75105186) with superior product profiles....Additionally, we are highly encouraged with the rate of enrollment in the Phase 2 study of our oral alpha-4-beta-7 integrin antagonist PN-943, for ulcerative colitis, an indication with a large patient population and unmet treatment need. We maintain our guidance of a data readout in Q2 2022..."

Discontinued • P2 data • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis

PN232. Carotid Endarterectomy: Past, Present, and Future! (ASA 2021) - "Explore the current state of evidence that compares regional versus general anesthesia for carotid endarterectomy. Discuss the efficacy of different neuromonitoring techniques and their advantages and disadvantages."

Anesthesia • Cardiovascular

Protagonist Therapeutics Reports Second Quarter 2021 Financial Results and Recent Company Progress (PRNewswire) - "License and Collaboration Revenue; License and collaboration revenues were $2.3 million and $8.5 million for the three and six months ended June 30, 2021....This follows as the Company in 2021 is now nearing completion of its remaining service obligations being provided under the collaboration. In particular, we are near the end of both the ongoing phase 1 trials in PN-235 & PN-232, which are expected to be completed in the fourth quarter of 2021 and early 2022, respectively. Research and Development Expenses; R&D expenses for the three and six months ended June 30, 2021 were $26.4 million and $50.7 million....The increases were primarily due to additional costs associated to advancing our clinical trials with our pipeline assets rusfertide and PN-943, as well as our second-generation IL-23 receptor antagonist assets under the Janssen collaboration (PN-235 and PN-232)."

Commercial • Trial completion date • Crohn's disease • Immunology

Protagonist Therapeutics Announces Amendment of Agreement with Janssen Biotech for the Continued Development and Commercialization of IL-23 Antagonists (PRNewswire) - "Protagonist Therapeutics...announced its entry into an amended collaboration agreement (the 'Restated Agreement') with Janssen Biotech...relating to research, development, manufacture and commercialization of multiple oral Interleukin (IL)-23 receptor antagonist drug candidates. The compounds currently in development are PTG-200, an oral IL-23 receptor antagonist in Phase 2 development for the treatment of Crohn's disease (CD), and PN-232 and PN-235, two second-generation oral IL-23 receptor antagonist candidates....Under the terms of the Restated Agreement, Janssen will conduct all future studies beyond those that are currently ongoing with PTG-200, PN-232 and PN-235 and will be solely financially responsible for any such studies."

Licensing / partnership • Crohn's disease • Immunology • Inflammatory Bowel Disease

Protagonist Therapeutics Announces First Subject Dosed in Phase 1 Study of Oral IL-23 Receptor Antagonist PN-232 (PRNewswire) - "Protagonist Therapeutics, Inc...announced that the first human subject has been dosed in a Phase 1 study of PN-232, a novel oral interleukin-23 receptor (IL-23R) antagonist peptide. This study is designed to determine the safety, tolerability, and pharmacokinetics of PN-232 in healthy volunteers. Recruitment for the study is ongoing."

Enrollment status • Trial status • Crohn's disease • Immunology • Inflammatory Bowel Disease

Protagonist Reports First Quarter 2021 Financial Results and Provides Corporate Update (PRNewswire) - "In the second quarter of 2021, Protagonist expects to dose the first subject in the Phase 1 study of PN-232. The Company expects to complete both this trial and the Phase 1 trial of PN-235 in the second half of 2021...Research and Development ('R&D') Expenses: R&D expenses for the first quarter 2021 were $24.2 million as compared to $18.8 million for the same period of 2020. The increase was primarily due to costs associated with advancing our clinical trials with our pipeline assets of rusfertide and PN-943, as well as our three IL-23 receptor antagonist assets under the Janssen collaboration (PTG-200, PN-235 and PN-232)."

Commercial • New P1 trial • Trial completion date • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Pharmacokinetics of PN-232 in Healthy Volunteers (clinicaltrials.gov) - P1; N=84; Recruiting; Sponsor: Protagonist Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open

Pharmacokinetics of PN-232 in Healthy Volunteers (clinicaltrials.gov) - P1; N=84; Not yet recruiting; Sponsor: Protagonist Therapeutics, Inc.

New P1 trial

Protagonist Therapeutics Announces Advancement of Oral IL-23 Receptor Antagonists Program in Collaboration with Janssen (PRNewswire) - "Protagonist Therapeutics...announced that two additional oral peptide IL-23 receptor antagonist candidates from its collaboration agreement with Janssen Biotech, Inc., have been selected for advancement into clinical development. The two new candidates, PN-235 (JNJ-77242113) and PN-232 (JNJ-75105186), are being developed as part of a portfolio strategy of discovering and developing oral IL-23 receptor antagonists. The initial oral candidate in the collaboration agreement, PTG-200 (JNJ-67864238), is currently in a Phase 2 proof-of-concept study in patients with moderate to severe Crohn's disease....We look forward to the initiation of a Phase 1 study of PN-235 in the fourth quarter of 2020."

New P1 trial • Crohn's disease • Gastrointestinal Disorder