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Protagonist Therapeutics Protagonist Therapeutics Reports Second Quarter 2021 Financial Results and Recent Company Progress August 4 , 2021 -- NEWARK , Calif . , Aug. 4 , 2021 / PRNewswire / Protagonist Therapeutics , Inc. ( Nasdaq : PTGX ) ( " Protagonist " or " the Company " ) today reported its financial results for the second quarter ended June 30 , 2021 , and an overview of recent company progress . " The second quarter of 2021 was one of enormous progress , achievement , and growth for our Company , " said Dinesh V. Patel , Ph.D. , President and Chief Executive Officer . " In April , we announced completion of enrollment for our Phase 2 study of rusfertide in polycythemia vera , data from which supported the U.S. Food and Drug Administration's Breakthrough Therapy Designation . In mid - June , we shared updated results from this Phase 2 study in an oral presentation at the European Hematology Association's 2021 Virtual Congress . This data , from 63 patients , continues to demonstrate rusfertide's potential as the first - in - class , non - cytoreductive treatment option for this disease . The durability of effect and symptom improvements observed provided further support for the advancement of rusfertide into Phase 3 clinical development , expected to commence in early 2022. " Dr. Patel continued , " Looking ahead to the remainder of this year and into early 2022 , Protagonist has multiple catalysts in view and underway . We intend to announce a third indication for rusfertide , beyond polycythemia vera and hereditary hemochromatosis . We look forward to sharing , for the first time , data from our clinical proof - of - concept study of rusfertide in hereditary hemochromatosis . In the fourth quarter , we are excited to share data from the completed Phase 2 study of rusfertide in polycythemia vera , meanwhile preparing diligently for the Phase 3 study . Finally , we remain intensely engaged in the successful execution of our Phase 2 study of PN - 943 in ulcerative colitis and intend to share data from this study in the second quarter of 2022. " Second Quarter 2021 Recent Developments and Upcoming Milestones Rusfertide : Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera ( PV ) and Other Blood Disorders • • Completed enrollment in the Phase 2 study of rusfertide in PV . Reported updated results from the Phase 2 study of rusfertide in PV at the European Hematology Association ( EHA ) 2021 Virtual Congress , which was selected for an oral presentation . The Company expects to report further updated data in PV by the end of 2021 . • Secured Breakthrough Therapy Designation from the FDA for rusfertide in PV . • Plan to announce third indication beyond PV and hereditary hemochromatosis ( HH ) by the end of 2021 . • Intend to report preliminary data from Phase 2 proof - of - concept study in HH by the end of 2021 . • On track to commence Phase 3 study of rusfertide in PV in early 2022 . PN - 943 : Oral , gut - restricted , alpha - 4 - Beta - 7 Integrin Antagonist for Ulcerative Colitis • Announced significant progress in the enrollment and execution of the Phase 2 study of PN - 943 in ulcerative colitis , revising guidance in anticipation of a sooner - than - expected data readout of the completed study . The Company expects to report results of the completed study in the second quarter of 2022 . Oral IL - 23 Receptor Antagonists ( Janssen Biotech and Protagonist Collaboration ) • As disclosed in July 2021 , the oral IL - 23 receptor antagonists collaboration between Janssen Biotech and Protagonist has advanced and expanded through an amendment to the original agreement . • The amended agreement provides for Janssen to lead worldwide development , manufacturing , and commercialization , and also broadens the range of indications contemplated for these drug candidates . Protagonist's development and expense obligations are now limited to the ongoing PTG - 200 Phase 2a study in Crohn's disease and to the ongoing Phase 1 studies investigation PN - 232 and PN - 235 . • Under the amended agreement , Protagonist remains eligible for approximately $ 900M in future milestone payments , in addition to the $ 80M in payments already received under the original agreement . • The Phase 1 study of PN - 235 , the first of the second - generation oral IL - 23 receptor antagonists included in the Janssen collaboration , is in progress , with study completion expected in the fourth quarter of 2021 . • Announced the dosing of the first human subject in a Phase 1 study of PN - 232 , the second of the second - generation oral IL - 23 receptor antagonist peptides included in the collaboration with Janssen .