Climb Bio Inc. (NASDAQ:CLYM) on Thursday released preliminary data from its ongoing Phase 1 trial assessing CLYM116, while revealing updated strategic plans for treating IgA nephropathy, a kidney disease.
The clinical-stage biotechnology firm is developing therapeutics for patients suffering from immune-mediated conditions and aims to advance its anti-APRIL monoclonal antibody toward a late-stage registrational study.
Phase 1 Data Demonstrates Strong Profile
The ongoing study evaluated subcutaneous CLYM116 across single-ascending and multiple-ascending doses in 46 healthy volunteers. The trial measured safety, tolerability, pharmacokinetics, and pharmacodynamics.
Results showed a favorable safety profile with no dose-limiting toxicities, serious adverse events, or hypogammaglobulinemia.
Pharmacokinetic and pharmacodynamic modeling supported an every-12-week dosing schedule. Data from a 320 mg multiple-ascending dose indicated a projected half-life of approximately 29 days, three times longer than sibeprenlimab.
Furthermore, a single 320 mg dose suppressed free APRIL by more than 90% and achieved 60% to 75% suppression of IgA, Gd-IgA1, and IgM through 12 weeks.
Strategic Next Steps in IgA Nephropathy
Climb Bio is leveraging these results in its ongoing open-label Phase 2 NAVIGATE-2 study for IgA nephropathy.
The trial evaluates an 800 mg loading dose followed by 400 mg given every eight or 12 weeks to confirm the optimal regimen for Phase 3.
To support patient delivery, the company created a high-concentration formulation enabling a 400 mg subcutaneous injection.
It also finished developing a pre-filled syringe for registrational testing and is currently building an autoinjector.
Upcoming Key Corporate Milestones
Management expects to share additional Phase 1 results alongside initial Phase 1 healthy volunteer trial data from Beijing Mabworks Biotech Co. during a medical meeting in the fourth quarter of 2026.
Preliminary NAVIGATE-2 Phase 2 data will arrive in the first half of 2027, followed by the launch of a Phase 3 study in 2027.
CLYM Stock Price Activity: Climb Bio shares were down 1.69% to $14.80 at the time of publication on Thursday, according to Benzinga Pro data.
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