Noticias y eventos de Climb Bio Inc (CLYM)CLYMClimb Bio Inc

Climb Bio Announces Clinical Data for Budoprutug

Climb Bio announced new clinical data for budoprutug, its anti-CD19 monoclonal antibody, in two immune-mediated renal diseases, primary membranous nephropathy and minimal change disease, MCD. These data were presented at the American Society of Nephrology, ASN, Kidney Week 2026, which is taking place October 21-25, 2026, in Denver, Colorado. PrisMN is an ongoing Phase 2 dose-escalation trial evaluating budoprutug at three dose levels in patients with moderate to severe pMN. Patients enrolled in the reported cohorts were treatment-experienced, with high proteinuria and elevated PLA2R antibody levels at baseline. At Week 12, the 200 mg cohort demonstrated B-cell depletion, reductions in PLA2R antibody levels, and immunologic remission. Initial data from the ongoing 600 mg cohort suggest greater drug exposure and deeper peripheral B-cell depletion compared with 200 mg. Budoprutug has been generally well tolerated in both cohorts to date, with follow-up through Week 12 for 200 mg and Week 6 for 600 mg. Enrollment is ongoing in the 1000 mg cohort.

Climb Bio Announces Additional Phase 1 Data for CLYM116

Climb Bio announced additional Phase 1 data in healthy volunteers for CLYM116/MIL116, an anti-APRIL monoclonal antibody, in development for IgA nephropathy. These data were presented at the American Society of Nephrology Kidney Week 2026, which is taking place October 21-25, 2026, in Denver, Colorado. CLYM116/MIL116 is being evaluated in complementary Phase 1 trials in Australia and China. Both are randomized, double-blind, placebo-controlled, ascending-dose studies designed to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneous CLYM116/MIL116 in healthy volunteers and enrolled 46 and 42 participants respectively. Near-complete free APRIL suppression was sustained through 12 weeks following a single SC dose greater than or equal to480 mg. Following a single 800 mg dose, ~70% reduction in Gd-IgA1 and ~60% reduction in IgA were observed at 12 weeks. PK was consistent across both studies. Exposure was linear, with no target-mediated drug disposition observed across the effective dose range. Together, these PK and PD data support an every 12-week dosing regimen. CLYM116/MIL116 has been generally well tolerated, with no dose limiting toxicities, treatment-related serious adverse events, or hypogammaglobulinemia. The NAVIGATE-2 Phase 2 trial is currently enrolling IgAN patients to confirm the Q12W dosing regimen, and a global Phase 3 trial is expected to initiate in 2027, pending regulatory feedback. "What excites us most about these two datasets is that they offer complementary validation of what we view as a best-in-class anti-APRIL profile for IgA nephropathy," said Aoife Brennan, M.B., Ch.B., President and Chief Executive Officer of Climb Bio. "CLYM116 was engineered as a sweeper antibody, and we've now seen this mechanism translate into superior in vivo potency, extended half-life, and predictable, linear exposure across two, parallel clinical studies. This differentiated pharmacokinetic profile drives deep and durable APRIL suppression, leading to substantial reductions in IgA and Gd-IgA1, a key pathogenic driver of IgAN. Our ability to rapidly generate this body of evidence reflects the strength of our partnership with Mabworks and allows us to accelerate this potentially transformative program into later-stage development."

Climb Bio Announces Initial Data for CLYM116

Climb Bio announced initial data from the ongoing Phase 1 trial evaluating CLYM116, an anti-APRIL monoclonal antibody, and provided updates on its strategy for further development in IgA nephropathy. CLYM116 demonstrated a favorable safety and tolerability profile with no serious adverse events, dose-limiting toxicities, or hypogammaglobulinemia. There was an approximately 29-day half-life projected based on CLYM116 320 mg MAD, threefold longer than sibeprenlimab greater than 90% free APRIL suppression following a single 320 mg dose, with potential for sustained APRIL suppression with an every-12-week dosing regimen. There was approximately 60%-75% IgA, Gd-IgA1, and IgM suppression following a single 320 mg dose, with suppression maintained through 12 weeks. PK/PD modeling further supports Q12W dosing of CLYM116. Additional data from the ongoing Phase 1 study and initial reporting of Beijing Mabworks Biotech Co., Ltd. Phase 1 healthy volunteer study in China to be presented at an upcoming medical meeting in the fourth quarter of 2026. Initial data from NAVIGATE-2 Phase 2 anticipated in the first half of 2027. Initiation of Phase 3 registrational study anticipated in 2027.