Our Science

Pipeline

Advancing Obexelimab for Patients with Autoimmune Diseases

Zenas is committed to being a leader in the development and commercialization of transformative immunology-based therapies for patients in need. This begins with obexelimab, a potential franchise within a molecule, targeting B cell mediated autoimmune diseases.

  • Immunoglobin G4-related Disease (IgG4-RD)

    Targeted enrollment is complete in our INDIGO trial, a global Phase 3 registration-directed, double-blind, placebo-controlled trial to evaluate the safety and efficacy of obexelimab in patients with active IgG4-RD in a randomized controlled period (RCP) followed by an optional open-label extension (OLE) period. We enrolled approximately 190 patients in the RCP, followed by an opportunity for eligible patients to continue in the OLE period. The trial is being conducted at approximately 100 sites in 20 countries. Learn more at: NCT05662241.

  • Multiple Sclerosis (MS)

    We are enrolling the MoonStone trial, a Phase 2 multicenter, randomized, double-blind, placebo-controlled trial, to evaluate the efficacy and safety of obexelimab in patients with relapsing MS (RMS). The trial will utilize various MRI detection techniques and biomarkers to assess its impact in both the active and chronic aspects of the disease. The primary objective of this trial will be to compare the cumulative number of gadolinium (Gd) enhancing lesions identified on T1-weighted MRI after 12 weeks in patients receiving obexelimab versus placebo. Secondary objectives will utilize standardized assessments, imaging and biomarkers to evaluate obexelimab’s effect on disease progression/silent progression. Upon completion of the 12-week period, patients initially on placebo will receive obexelimab treatment for at least 12 weeks, and patients initially randomized to obexelimab will continue on treatment. Learn more at: NCT06564311.

  • Systemic Lupus Erythematosus (SLE)

    We are enrolling the SunStone trial, a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of obexelimab when used to reduce disease activity in patients with SLE. We expect to enroll approximately 190 patients and conduct the trial at multiple sites worldwide. Patients will be randomized 1:1 to obexelimab or placebo over 24 weeks. The primary endpoint will be the percentage of responders, defined by BILAG-based Composite Lupus Assessment (BICLA), with a reduction of SLE disease activity at week 24. Learn more at: NCT06559163.

  • Warm Autoimmune Hemolytic Anemia (wAIHA)

    We are currently enrolling patients in the open-label safety and dose confirmation portion of our global Phase 2 multicenter SApHiAre trial to establish proof of mechanism for obexelimab in patients with wAIHA. Learn more at: NCT05786573.

  • Other Pipeline Programs

    Beyond our lead product candidate, obexelimab, we are advancing a pipeline of clinical programs for the potential treatment of other autoimmune diseases that we may continue to develop and ultimately commercialize with partners. These pipeline programs include ZB001, ZB002 and ZB004.