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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.
Climb Bio Set for Defining Milestones in 2026
"2026 is proving to be a defining year for Climb Bio, and I am thrilled by the team's execution," said Aoife Brennan, President and Chief Executive Officer of Climb Bio. "We achieved important milestones for both budoprutug and CLYM116 over the past few months, and that momentum continues into the second half of the year with further data readouts across all four of our ongoing trials and the initiation of a Phase 2 trial of CLYM116 in IgAN patients. Currently at the forefront, I look forward to sharing initial Phase 1 data from CLYM116 in our September R&D Spotlight, where we will further highlight its potential as a best-in-class anti-APRIL antibody and provide additional details on our development strategy. With our continued progress across our pipeline, and supported by our strengthened balance sheet, we are well positioned to continue to execute on our strategic priorities and rapidly advance both programs toward pivotal development, setting the stage for what we believe will be an exciting 2027 for Climb."
Climb Bio Announces Initial Data on Budoprutug
Climb Bio announced initial data from the ongoing Phase 1b portion of its Phase 1b/2a study evaluating budoprutug, an anti-CD19 monoclonal antibody, in adults with primary immune thrombocytopenia demonstrating an encouraging safety and tolerability profile, robust B-cell depletion, and meaningful platelet responses in heavily pretreated patients. The initial data are being presented at the European Hematology Association, or EHA, Congress 2026, which is being held on June 11-14 in Stockholm, Sweden. The ongoing Phase 1b/2a study is evaluating budoprutug in patients with primary ITP to inform dose and regimen selection and assess safety and the depth and duration of platelet response and B-cell depletion. Initial safety and efficacy data are available from the 250 mg cohort, and initial safety data are available from the 500 mg cohort. Enrollment in the 1000 mg cohort is ongoing. The Phase 1b portion of the Phase 1b/2a study is evaluating three ascending doses of intravenous budoprutug, administered in two doses 14 days apart, in adults with primary ITP who have received at least one prior therapy. As of June 1, 15 patients had been enrolled across the 250 mg and 500 mg dose cohorts, median follow-up was 38 weeks and 12 weeks for the 250 mg and 500 mg cohorts respectively. Patients enrolled were heavily pretreated, with a median of 6 to 7.5 prior lines of therapy and disease duration ranging from 0.5 to 40 years. Budoprutug was generally well tolerated at both the 250 mg and 500 mg dose levels, with no serious adverse events, no treatment discontinuations due to adverse events, and no infusion related reactions; all adverse events were Grade 1 to Grade 2. In the 250 mg dose cohort, B-cell levels were depleted by an average of over 90% by Week 4 and mean platelet count increased by 111,000 platelets/microL at Week 24. Durable platelet responses were achieved in four out of six patients in the 250 mg dose cohort, with two out of six patients experiencing platelet levels greater than100 x 103/microL for over 24 weeks. Of the four patients who had previously been treated with rituximab, three responded to treatment with budoprutug, two with durable and complete responses Results to date support continued clinical evaluation of budoprutug in ITP; enrollment in the 1000 mg cohort is ongoing.
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