PTG-200 / Protagonist Therap, J&J - LARVOL DELTA

A study to learn about the efficacy and safety of JNJ-67864238 in participants with Crohn's disease. (clinicaltrialsregister.eu) - P2 | N=90 | Terminated | Sponsor: JANSSEN CILAG INTERNATIONAL NV

New P2 trial • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

PRISM: A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2; N=48; Terminated; Sponsor: Janssen Research & Development, LLC; Trial completion date: May 2022 ➔ Dec 2021; Active, not recruiting ➔ Terminated; IAC completed review of futility analysis data & determined that futility criteria were met. As a result, Janssen made decision to stop trial immediately.

Trial completion date • Trial termination • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • CRP • TNFA

PRISM: A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2; N=48; Active, not recruiting; Sponsor: Janssen Research & Development, LLC; Recruiting ➔ Active, not recruiting; N=90 ➔ 48

Clinical • Enrollment change • Enrollment closed • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • CRP • TNFA

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

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

PRISM: A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2; N=90; Recruiting; Sponsor: Janssen Research & Development, LLC; Trial primary completion date: May 2021 ➔ Dec 2021

Trial primary completion date • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • CRP • TNFA

PRISM: A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2; N=90; Recruiting; Sponsor: Janssen Research & Development, LLC; Trial completion date: Sep 2021 ➔ Mar 2022

Clinical • Trial completion date • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • CRP • TNFA

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

PTG-200: Patent expiry in US in 2035 (Protagonist Therapeutics) - Annual Report 2020

Patent • Inflammatory Bowel Disease

PRISM: A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2; N=90; Recruiting; Sponsor: Janssen Research & Development, LLC; Trial completion date: May 2021 ➔ Sep 2021

Clinical • Trial completion date • Colorectal Cancer • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • TNFA

Protagonist Therapeutics reports first quarter 2018 financial results (PRNewswire) - "In the second half of 2018 we expect a U.S. IND filing and other regulatory filings for a global Phase 2 study of PTG-200 in Crohn's disease to be conducted in collaboration with Janssen."

IND • Immunology • Inflammation • Inflammatory Bowel Disease

PTG-200: Completion of P1 study for Crohn's disease in H2 2018 (Protagonist Therapeutics) - Corporate Presentation

Trial completion date • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease

PTG-200: Data from P1 trial for Crohn’s disease in 2018 (Protagonist Therapeutics) - Q4 & FY 2017 Results

P1 data • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease

Protagonist Therapeutics announces completion of phase 1 clinical trial of oral IL-23 receptor antagonist PTG-200 (PRNewswire) - "Protagonist Therapeutics...announced top-line results from the Phase 1 study of PTG-200...in 80 normal healthy volunteers. Results of...study demonstrated that administration of PTG-200 was well-tolerated. No serious adverse events or dose-limiting toxicities were observed. The pharmacokinetic and pharmacodynamic parameters were consistent with the gastrointestinal-restricted design of PTG-200....'We look forward to working towards a U.S. IND filing with our collaboration partner Janssen Biotech in the coming months.'"

IND • P1 data • Trial completion • Immunology • Inflammation • Inflammatory Bowel Disease

PTG-200: IND filing in US for initiation of P2 trial in Crohn's disease in Q1 2019 (Protagonist Therapeutics) - BMO Capital Markets 2018

IND • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease

Protagonist Therapeutics reports first quarter financial results and provides corporate update (PRNewswire) - "In collaboration with Janssen Biotech, we initiated a Phase 2 global study for PTG-200 (or JNJ-67864238) in moderate-to-severe Crohn's disease in the fourth quarter of 2019. Because of the global COVID-19 pandemic, guidance has been currently suspended on a timeline for study completion....R&D expenses for the first quarter 2020 were $18.8 million...The increase was primarily due to increased clinical development costs related to...develop PTG-200 and the related research collaboration efforts."

Clinical • Trial suspension • Immunology • Inflammation • Inflammatory Bowel Disease

Protagonist Therapeutics reports fourth quarter and full year 2019 financial results (PRNewswire) - "Protagonist Therapeutics and Janssen Biotech are jointly conducting the development of PTG-200 (or JNJ-67864238) through completion of a Phase 2a study in patients with moderate-to-severe Crohn's disease, with the anticipation of completion in the first half of 2021....The Company plans to initiate a Phase 2 study in patients with ulcerative colitis in the second quarter of 2020, with topline data expected in the second half of 2021."

Enrollment status • New P2 trial • P2 data

PTG-200: Patent expiry in US in 2035 (Protagonist Therapeutics) - Annual Report 2019

Patent

PTG-200: Data from P2 PRISM trial (NCT04102111) for Crohn’s disease in H1 2021 (Protagonist Therapeutics) - Corporate Presentation

P2 data

Kicking the tires on Protagonist Therapeutics (SeekingAlpha) - "The first patient has been dosed in the Phase 2 study of PTG-200 in patients with moderate to severe Crohn's disease. Results from the trial are expected to be released in 2021."

P2 data • Trial status

Protagonist Therapeutics achieves milestone in Janssen Biotech, Inc., collaboration (PRNewswire) - "Protagonist Therapeutics, Inc....today announced the achievement of a research milestone under its worldwide license and research collaboration agreement with Janssen Biotech, Inc....for co-development activities with affiliate Janssen Research & Development, LLC, and commercialization of...PTG-200 (JNJ-67864238) and second generation peptides for all indications including inflammatory bowel disease (IBD)."

Commercial • Licensing / partnership

Protagonist -1.2%; may offer up to $75M in shares (SeekingAlpha) - "Protagonist Therapeutics...is down 1.2% postmarket after filing to offer up to $75M worth of shares. It's entered into an open market sale agreement with Jefferies. Any net proceeds will be used to fund clinical research and development of clinical-stage assets, including continued development of PTG-300, PTG-200 and PN-943."

Financing

PTG-200: Data from P2 trial for Crohn’s disease in H1 2021 (Stifel 2019 Healthcare Conference, Protagonist Therapeutics)

P2 data

PTG-200: Data from P2 trial for Crohn’s disease in H1 2021 (Stifel 2019 Healthcare Conference, Protagonist Therapeutics)

P2 data

Protagonist Therapeutics announces first patient dosed in a phase 2 study of oral IL-23 receptor antagonist PTG-200 (JNJ-67864238) in the treatment of Crohn’s disease (PRNewswire) - P2, N=90; PRISM (NCT04102111); Sponsor: Janssen Research & Development, LLC; "Protagonist Therapeutics, Inc. (Nasdaq:PTGX) today announced that the first patient has been dosed in a Phase 2 study of PTG-200 (also referenced as JNJ-67864238) in patients with moderate to severe Crohn's disease...The global, randomized, double blind, placebo-controlled, Phase 2 study is evaluating the efficacy of oral administration of PTG-200 in 90 patients with moderate to severe Crohn's disease...Clinical efficacy results for the Janssen Collaboration Asset are expected in 2021."

Enrollment open • P2 data