Protagonist Therapeutics

STAT's biotech newsletter highlights key sector events, including Ultragenyx and Praxis's Phase 3 trials, Trump's FDA transition plan, Eli Lilly's lawsuit involvement over tirzepatide, and Biden's science and tech awards to CRISPR scientists and mRNA vaccine developers.

Protagonist Therapeutics, with strong financial health and a 95% return over the past year, is advancing its lead candidate, rusfertide, in Phase 3 trials for polycythemia vera. Strategic partnerships with Johnson & Johnson and Takeda support pipeline growth. The company's robust cash position sustains operations through 2027, with a diverse pipeline including PN-881 for psoriasis. Key clinical trial outcomes will significantly impact its market position and growth potential.

AbbVie to acquire Nimble Therapeutics for $200M, gaining its oral peptide drugs for immune diseases and technology for peptide-based drug synthesis. Nimble's lead candidate inhibits IL-23, same target as AbbVie's Skyrizi, and is in preclinical testing. The acquisition aims to strengthen AbbVie's immunology pipeline.

Takeda's late-stage pipeline includes six programs with peak revenue potential of $10B - $20B, with Phase 3 data readouts expected in 2025 for Oveporexton, Zasocitinib, and Rusfertide. Regulatory filings for these drugs are planned for FY2025-2026, with additional filings anticipated through FY2029.

Protagonist Therapeutics announced positive Phase 3 results for their psoriasis drug, icotrokinra, showing significant skin clearance with a daily oral dose. The drug targets moderate-to-severe plaque psoriasis, affecting over 500,000 Australians annually. Results are being prepared for submission to health authorities. Protagonist, founded by Associate Professor Mark Smythe, aims to develop oral drugs using peptides, inspired by venom-derived molecules.

Rusfertide, a hepcidin mimetic, showed durable hematocrit control, reduced phlebotomy use, and improved patient outcomes in polycythemia vera patients over 2.5 years in the REVIVE Phase 2 study. Rusfertide was well-tolerated, with mild to moderate adverse events.

Protagonist Therapeutics announced positive Phase 3 results for their psoriasis drug, icotrokinra, showing significant skin clearance with a daily oral dose. The drug targets moderate-to-severe plaque psoriasis, affecting over 500,000 Australians annually. Results are being prepared for submission to health authorities and presentation at medical congresses. Protagonist, founded by Associate Professor Mark Smythe, aims to develop oral drugs using peptides, inspired by venom-derived molecules.

Rusfertide, a hepcidin mimetic, demonstrated durable hematocrit control (<45%) and decreased phlebotomy use in polycythemia vera patients for over 2.5 years, with long-term tolerability and improved patient-reported outcomes, according to final data from the Phase 2 REVIVE study presented at the 66th ASH Annual Meeting.

November's dermatology highlights include FDA approval of bimekizumab for HS, resubmissions for dupilumab and pz-cel, obesity's link to psoriasis, JNJ-2113's efficacy in psoriasis, stress's impact on skin aging, and factors affecting HS diagnostic wandering.

J&J and Protagonist Therapeutics report positive phase 3 results for icotrokinra in treating moderate-to-severe plaque psoriasis, with significant improvements in IGA and PASI scores compared to placebo.