Climb Bio reports Phase 1 data for anti-APRIL antibody CLYM116 in IgA nephropathy program
The company said a single 320 mg dose drove near-complete APRIL suppression and 60-75% IgA and Gd-IgA1 reduction through 12 weeks, supporting a possible every-12-week dosing schedule.
Climb Bio, Inc. (Nasdaq: CLYM) announced on September 3, 2026 initial data from its ongoing Phase 1 trial of CLYM116, an anti-APRIL monoclonal antibody being developed for IgA nephropathy.
The trial is a randomized, double-blind, placebo-controlled, single-ascending-dose (SAD) and multiple-ascending-dose (MAD) study that enrolled 46 subjects and was designed to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneous CLYM116 in healthy volunteers.1
On safety, the company reported that CLYM116 was tolerated without serious adverse events turning up, without dose-limiting toxicities, and without cases of low immunoglobulin levels, based on data described in the release as demonstrating a favorable safety and tolerability profile with no serious adverse events, dose-limiting toxicities, or hypogammaglobulinemia.1
On pharmacology, the company said the drug showed a roughly 29-day half-life projected based on the 320 mg multiple-ascending-dose data, which the company said was threefold longer than sibeprenlimab.1 A single 320 mg dose produced more than 90% suppression of free APRIL, with potential for sustained suppression under an every-12-week dosing regimen.1 The same dose also produced roughly 60-75% suppression of IgA, Gd-IgA1, and IgM, with that suppression maintained through 12 weeks.1 The company added that pharmacokinetic and pharmacodynamic modeling further supports the every-12-week dosing schedule.1
On next steps, Climb Bio is running a Phase 2 study called NAVIGATE-2 in IgA nephropathy, a randomized, open-label trial evaluating an 800 mg loading dose followed by 400 mg dosed every 8 or every 12 weeks, intended to support advancing the 12-week regimen into Phase 3.1 The company said it anticipates initial data from NAVIGATE-2 in the first half of 2027 and initiation of a Phase 3 registrational study in 2027.1 Additional Phase 1 data and initial results from a related Phase 1 study run in China by Beijing Mabworks Biotech Co., Ltd. are expected to be presented at a medical meeting in the fourth quarter of 2026.1
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