Climb Bio has reported positive initial findings from its ongoing Phase I trial of CLYM116, an anti-A Proliferation-Inducing Ligand (APRIL) monoclonal antibody being tested in healthy volunteers as a potential treatment for IgA nephropathy (IgAN).
The double-blind, randomised, single-ascending-dose, placebo-controlled and multiple-ascending-dose study included 46 participants to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneous CLYM116.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The data indicate CLYM116 was associated with a favourable safety profile, with no recorded dose-limiting toxicities, hypogammaglobulinaemia or serious adverse events.
Pharmacokinetic results suggest a projected half-life of approximately 29 days for the 320mg multiple-ascending-dose group, which is about three times longer than sibeprenlimab.
The trial observed a more than 90% free APRIL suppression following a single 320mg dose.
This suppression, as well as reductions in immunoglobulins IgA, Gd-IgA1, and IgM by around 60%-75%, were maintained through 12 weeks.
Climb Bio president and CEO Aoife Brennan said: “We are thrilled with the compelling initial data for CLYM116. APRIL is a clinically validated target in IgA nephropathy, and we designed CLYM116 to raise the bar on how completely and how durably it can be suppressed.
“As a sweeper antibody, CLYM116 was engineered to facilitate the degradation of APRIL rather than simply bind it. Our initial data show that this mechanism translated to rapid and durable APRIL suppression and substantial reductions in IgA and Gd-IgA1, with a favourable safety and tolerability profile.
“We believe this combination of depth, durability, and the potential for an every-12-week dosing regimen supports a best-in-class profile for CLYM116 in IgAN with the potential to meaningfully improve patient care.”
As part of its future development strategy, Climb Bio is conducting the Phase II NAVIGATE-2 study, which is evaluating dosing regimens of CLYM116 with an 800mg loading dose and subsequent 400mg administration every eight or 12 weeks.
Initial data from this study are expected in the first half of 2027.
The company is planning a Phase III registrational study, anticipated for launch in the same year, pending further results.
