Protagonist Therapeutics Announces the Selection of Oral Peptide PN-235 into Phase 2 Clinical Development Program for Multiple Indications

PN-235 (JNJ-77242113) now expected to advance into multiple Phase 2 clinical studies in 2022, for indications including psoriasis and inflammatory bowel diseases

NEWARK, CA, USA I December 2, 2021 I Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the Company") today announced the selection of PN-235 (JNJ-77242113) as the final candidate for all clinical studies in multiple indications based on intervention of the Interleukin-23 (IL-23) pathway, under the Company's collaboration with Janssen Biotech, Inc. (Janssen). In addition to the previously announced Phase 2 clinical study of PN-235 in psoriasis, new Phase 2 clinical studies of PN-235 in inflammatory bowel diseases (IBD) are expected to commence in late 2022. Further development of PN-232 (JNJ-7510586) will be discontinued in favor of PN-235 based on its superior potency, and overall pharmacokinetic and pharmacodynamic profile.

"We are delighted to see PN-235 emerge as the clear focal point going forward, after over four-plus years of a highly productive and ongoing collaboration with Janssen," said Dinesh V. Patel, PhD, President and CEO of Protagonist. "We look forward to exploring the full potential of a highly differentiated, oral targeted therapy like PN-235, thereby potentially addressing persistent unmet needs of patients with immune-mediated diseases like psoriasis and IBD."

Protagonist will earn a $25 million milestone in connection with the initiation of the first Phase 2 study of PN-235 in psoriasis in early 2022. Protagonist is also eligible for a $10 million milestone in connection with the start of the second indication-based Phase 2 study. Protagonist is eligible for up to approximately $900 million in development-related milestone payments, in addition to the $87.5M in milestones already earned. Under the terms of the collaboration, Janssen will conduct all future clinical studies, including these anticipated Phase 2 studies, and will be solely financially responsible for any such studies.

About Protagonist

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

Protagonist's pipeline includes rusfertide (PTG-300), an investigational, injectable hepcidin mimetic currently in a Phase 2 proof-of-concept clinical trial for polycythemia vera (PV), a Phase 2 study in PV subjects with high hematocrit levels, and a recently completed Phase 2a study for hereditary hemochromatosis. The Company plans to initiate 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 a Phase 2 study in adults with moderate to severe active ulcerative colitis (UC). The Company is targeting ulcerative colitis as the initial indication.

The Company has a worldwide license and collaboration agreement with Janssen Biotech, Inc., for the development of oral peptide IL-23 receptor antagonists. Compounds in development include PN-235, a second-generation oral interleukin-23 receptor antagonist candidate. Under the collaboration with Janssen, PN-235 is expected to advance into Phase 2 studies in psoriasis and new Phase 2 clinical studies in inflammatory bowel diseases.

SOURCE: Protagonist Therapeutics

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