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Veru Advances Oral Sabizabulin Following Positive Preclinical Data Showing Potent Anticancer Activity in Human Daraxonrasib (Revolution Medicines’ RASONQUE™) Resistant Pancreatic Cancer into a Planned Phase 2 Clinical Trial

VERU
  • New preclinical data confirms sabizabulin overcomes daraxonrasib resistance in KRAS-driven pancreatic & colon cancer cell lines with potent efficacy (IC50=18.2nM) achievable via current human dosing.
  • Veru Inc. strategically advanced oral sabizabulin into a planned Phase 2b clinical trial for metastatic pancreatic cancer patients progressing on daraxonrasib while ceasing development for atherosclerotic cardiovascular disease.
  • Previous first-in-man Phase 1b/2 trials demonstrated oral sabizabulin's good safety profile & promising efficacy in 80 subjects with metastatic castration-resistant prostate cancer.
  • Sabizabulin targets downstream KRAS signaling components & TUBB3 to induce cell death in resistant cancers without being affected by multidrug resistance pumps.
  • Veru holds global development & commercialization rights for sabizabulin with IP protection until 2043.
  • The enobosarm obesity program remains on track with the Phase 2b PLATEAU trial fully enrolled at 239 patients & an interim analysis expected in Q1 2027.
  • A clinical supply agreement exists with Novo Nordisk for enobosarm, & a newly issued US patent protects the combination with semaglutide until late 2044.
  • Veru plans to seek regulatory clarity from the FDA via a pre-IND meeting in Q4 2026 regarding the sabizabulin pancreatic cancer trial.
  • The Phase 2b PLATEAU study aims to evaluate enobosarm's ability to enhance weight loss quality by preserving lean mass & physical function in older patients receiving GLP-1 RA therapy.