Protagonist Therapeutics Touts Positive Data From Bone Marrow Disorder Study

  • Protagonist Therapeutics Inc PTGX announced topline results from the blinded, placebo-controlled, randomized withdrawal portion of REVIVE of rusfertide for polycythemia vera, causing the bone marrow to make too many red blood cells. 
  • Subjects receiving rusfertide achieved highly statistically significant improvements versus placebo in the primary endpoint.
  • More subjects receiving rusfertide during the blinded randomized withdrawal portion of the REVIVE study were responders compared with placebo (69.2% versus 18.5%).
  • During the 12 weeks of the blinded randomized withdrawal, only 2 of 26 subjects on rusfertide were phlebotomized (withdraw blood surgically), keeping 92.3% of patients phlebotomy free in the rusfertide arm.
  • Rusfertide was well tolerated, with localized injection site reactions comprising the most reported adverse events. No new safety signals were observed.
  • The REVIVE study is now complete, with an open-label extension underway.
  • The 250-patient global Phase 3 VERIFY study of rusfertide in polycythemia vera is ongoing. 
  • Last week, Protagonist announced topline results from its collaboration with Janssen Biotech Inc, a part of Johnson & Johnson JNJ, in the FRONTIER 1 Phase 2b trial of oral Interleukin-23 receptor (IL-23R) antagonist peptide JNJ-2113 in patients with moderate-to-severe plaque psoriasis.
  • Data from the 255-patient study showed that JNJ-2113 achieved the study's primary efficacy endpoint.
  • Advancement of JNJ-2113 into a Phase 3 study and meeting the primary endpoint would qualify Protagonist for milestone payments of $50 million and $115 million, respectively. 
  • Price Action: PTGX shares are down 5.26% at $23.95 on the last check Wednesday.
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