Protagonist Therapeutics Earns $25 Million Milestone Payment from Janssen Biotech for Dosing of Third Patient in Phase 2b Clinical Trial of PN-235 in Moderate-to-Severe Plaque Psoriasis

Phase 2b clinical trial of PN-235, an oral IL-23 receptor antagonist, has launched with a target enrollment of 240 patients

NEWARK, Calif., March 16, 2022 /PRNewswire/ -- Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the Company") announced today earning a $25 million milestone payment from its collaboration with Janssen Biotech, Inc. (Janssen), following dosing of the third patient in the Phase 2b FRONTIER 1 clinical trial of PN-235 (JNJ-77242113).

"The start of this Phase 2b study in moderate-to-severe plaque psoriasis marks an exciting moment along the development pathway for this promising drug candidate, discovered through Protagonist's proprietary technology platform," said Dinesh V. Patel, Ph.D., President and CEO of Protagonist. "Advancing PN-235 aligns with our shared goal with Janssen to develop new therapies with transformational potential for patients in need."

FRONTIER 1 is a Phase 2b multicenter, randomized, placebo controlled, dose-ranging study to evaluate the safety and efficacy of PN-235 for the treatment of moderate-to-severe plaque psoriasis. This study commenced on February 3, 2022 and is expected to enroll 240 participants. More information on FRONTIER 1 can be found at clinicaltrials.gov.

Protagonist has granted Janssen an exclusive worldwide license to research, develop and commercialize oral IL-23 receptor antagonists based on the Company's intellectual property. Current development efforts are centered on PN-235, discovered by Protagonist and further developed in collaboration with Janssen.

Protagonist is eligible for up to approximately $850 million in development-related milestone payments, in addition to $112.5M in milestones already earned. Under terms of the collaboration, Janssen will conduct all future clinical studies, inclusive of Phase 2 and 3 studies. Janssen will be financially responsible for such studies.

Protagonist Therapeutics is a biopharmaceutical company with multiple peptide-based new chemical entities in different stages of clinical development, all derived from the Company's proprietary technology platform.

Protagonist's pipeline includes rusfertide, an investigational, injectable hepcidin mimetic currently in the REVIVE Phase 2 proof-of-concept clinical trial for polycythemia vera (PV), the PACIFIC Phase 2 study in PV subjects with high hematocrit levels, and a recently completed Phase 2a study for hereditary hemochromatosis. The Company is actively initiating VERIFY, a single, global Phase 3 randomized, placebo-controlled trial evaluating the efficacy and safety of a once weekly, subcutaneously self-administered dose of rusfertide.

The Company is also evaluating an orally delivered, gut-restricted alpha-4-beta-7 integrin specific antagonist peptide (PN-943), currently in the IDEAL Phase 2 study in adults with moderate to severe active ulcerative colitis. The Company is targeting ulcerative colitis as the initial indication.

Protagonist has granted Janssen an exclusive worldwide license to research, develop and commercialize oral IL-23 receptor antagonists based on the Company's intellectual property. Current development efforts are centered on PN-235, discovered by Protagonist and further developed in collaboration with Janssen.

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, future PN-235 clinical studies and the potential for drug candidates developed in our Janssen collaboration. 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 agreements, the impact of the current COVID-19 pandemic on our discovery and development efforts, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates.  Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our most recently filed periodic reports on Form 10-K and Form 10-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 the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release.  Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release.

SOURCE Protagonist Therapeutics Inc.