Climb Bio公布CLYM116（抗APRIL单抗）Phase 1健康志愿者数据，显示>90% APRIL抑制及12周给药潜力

Climb Bio ( CLYM ) added more than 13% during premarket trading on Thursday after reporting data from a Phase 1 trial for CLYM116, its anti-APRIL monoclonal antibody targeting a kidney disease known as IgA nephropathy. Citing initial data from the ongoing trial involving 46 healthy volunteers, Climb Bio ( CLYM ) noted more than 90% suppression in APRIL, a clinically validated target in IgA nephropathy, after an every-12-week dosing regimen of CLYM116. The subcutaneously delivered CLYM116 demonstrated a favorable safety and tolerability profile, with no serious adverse events or dose-limiting toxicities, according to the company. Also known as Berger disease, IgA nephropathy is characterized by the accumulation of a germ-fighting protein called IgA in the kidneys. Additional data indicated a ~60%-75% decline in several immunoglobulins, including IgA, following a single 320 mg dose of CLYM116, with the suppression lasting 12 weeks. Topline data from Climb Bio’s ( CLYM ) ongoing NAVIGATE-2 Phase 2 trial for CLYM116 in IgA nephropathy is expected in H1 2027. A Phase 3 registrational study for the candidate is also expected to start next year.