Climb Bio Inc. reported Phase 1 clinical data for CLYM116, an anti-APRIL monoclonal antibody being developed for IgA nephropathy. In a randomized, double-blind, placebo-controlled study involving 46 healthy volunteers, a single 320 mg subcutaneous dose of CLYM116 demonstrated sustained pharmacodynamic activity.
The drug achieved over 90% suppression of free APRIL and reduced IgA and galactose-deficient IgA1 levels by 60–75% through 12 weeks. The half-life of CLYM116 was approximately 29 days, and the company noted a high-concentration formulation of 200 mg/mL, with a 400 mg dose deliverable via a single subcutaneous injection using a pre-filled syringe. An autoinjector is under development.
Safety outcomes indicated that CLYM116 was generally well-tolerated, with no serious adverse events, dose-limiting toxicities, or cases of hypogammaglobulinemia reported during the trial.
CLYM116 employs a pH-dependent bind-and-release mechanism to block APRIL signaling and promote lysosomal degradation of the target protein. The Phase 2 NAVIGATE-2 trial is evaluating an 800 mg loading dose followed by 400 mg maintenance doses administered every 8 or 12 weeks.
Additional Phase 1 data and initial results from a healthy volunteer study conducted by Beijing Mabworks Biotech Co. are expected to be presented at a medical meeting in the fourth quarter of 2026. Initial data from the Phase 2 NAVIGATE-2 trial are anticipated in the first half of 2027, with a Phase 3 registrational study planned for 2027.
