Wellesley Hills, Mass., September 3, 2026
Climb Bio announced positive initial Phase 1 clinical data for CLYM116, its investigational anti-APRIL monoclonal antibody being developed for IgA nephropathy (IgAN). The data showed a projected ~29-day half-life and demonstrated that a single 320 mg dose produced near-complete APRIL suppression, along with approximately 60% to 75% reductions in IgA and Gd-IgA1 that were maintained through 12 weeks. The findings support the potential for an every-12-week (Q12W) dosing regimen as Climb Bio advances CLYM116 through clinical development.
CLYM116 Demonstrates Durable APRIL and Immunoglobulin Suppression
In the ongoing randomized, double-blind, placebo-controlled Phase 1 trial, CLYM116 was evaluated in 46 healthy volunteers to assess safety, tolerability, pharmacokinetics and pharmacodynamics following subcutaneous administration. A single 320 mg dose resulted in more than 90% free APRIL suppression, with suppression potentially sustained through a Q12W dosing schedule. CLYM116 also produced approximately 60% to 75% suppression of IgA, Gd-IgA1 and IgM, with these reductions maintained through 12 weeks. The company reported a favorable safety profile, with no serious adverse events, dose-limiting toxicities or hypogammaglobulinemia observed in the Phase 1 study.
Climb Bio Advances Phase 2 NAVIGATE-2 Study
The Phase 1 pharmacokinetic and pharmacodynamic findings are supporting the continued development of CLYM116 in IgA nephropathy. Climb Bio’s ongoing Phase 2 NAVIGATE-2 trial is evaluating an 800 mg loading dose, followed by either 400 mg every eight weeks or every 12 weeks. The development strategy is intended to determine the appropriate regimen for advancement into a registrational Phase 3 study. Climb Bio has also developed a 200 mg/mL high-concentration formulation, allowing a 400 mg dose to be delivered through a single subcutaneous injection. A pre-filled syringe has been developed for potential registrational use, while an autoinjector is also in development.
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Climb Bio Targets 2027 Phase 3 Development Milestone for CLYM116
Climb Bio expects to report initial NAVIGATE-2 Phase 2 data in the first half of 2027, followed by anticipated initiation of a Phase 3 registrational study in 2027. Additional Phase 1 data and initial results from a separate Mabworks Phase 1 healthy-volunteer study in China are expected to be presented at a medical meeting in the fourth quarter of 2026. The company believes the combination of deep APRIL suppression, sustained IgA and Gd-IgA1 reductions, prolonged half-life and potential Q12W dosing could support a differentiated development profile for CLYM116 in IgA nephropathy.
Source:Climb Bio press relese
