Climb Bio Shares Rise 17% After Phase 1 CLYM116 Trial Data

Climb Bio, Inc. (NASDAQ:CLYM) shares rose 17% on Thursday after the clinical-stage biotechnology company released Phase 1 trial data for CLYM116, its anti-APRIL monoclonal antibody being developed for IgA nephropathy.

The company reported that a single 320 mg dose of CLYM116 resulted in near-complete APRIL suppression and 60% to 75% suppression of IgA/Gd-IgA1 through 12 weeks.

CLYM116 demonstrated a half-life of approximately 29 days, which Climb Bio said is three times longer than that of sibeprenlimab.

Phase 1 Study Enrolled 46 Subjects

The randomized, double-blind, placebo-controlled Phase 1 trial enrolled 46 healthy volunteers and was designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous CLYM116.

According to the company, CLYM116 was generally well tolerated, with no serious adverse events, dose-limiting toxicities or hypogammaglobulinemia reported.

The trial data showed greater than 90% suppression of free APRIL following a single 320 mg dose. Climb Bio said the results indicate the potential for sustained suppression with dosing every 12 weeks, while its pharmacokinetic and pharmacodynamic modelling supports a quarterly dosing schedule.

NAVIGATE-2 Trial Evaluating CLYM116 in IgA Nephropathy

Climb Bio is currently evaluating CLYM116 in the Phase 2 NAVIGATE-2 trial for IgA nephropathy.

The study is assessing an 800 mg loading dose followed by 400 mg administered either every eight weeks or every 12 weeks.

The company expects to report initial data from NAVIGATE-2 in the first half of 2027 and plans to begin a Phase 3 registrational study during 2027.

Climb Bio Develops High-Concentration Formulation

Climb Bio has developed a high-concentration formulation designed to deliver a 400 mg dose through a single subcutaneous injection.

Development of a pre-filled syringe for the planned registrational study has been completed, while an autoinjector remains under development.

The company plans to present additional results from the Phase 1 study at a medical meeting during the fourth quarter of 2026.

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