Announcement • Mar 10
Novabridge Biosciences Announces Positive Results from Vis-101 Phase 2A Wet Amd Study
NovaBridge Biosciences announced positive topline results from the Phase 2a study of VIS-101, a purpose-designed tetravalent, dual VEGF-A X ANG-2 inhibitor in development for retinal vascular diseases including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). Topline results show that VIS-101 produced rapid, robust and durable treatment responses in wet AMD, with potential best-in-class durability and a favorable safety profile. Wet AMD affects more than 20 million people globally. VIS-101 produced rapid and robust efficacy, and durable treatment responses with both 3 mg and 6 mg dose cohorts. Mean improvement in Best Corrected Visual Acuity (BCVA) of >10 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters. Median central subfield thickness (CST) reduction of 100-150 mm. Potential best-in-class durability with approximately two thirds of patients retreatment-free at 4 months and approximately half of patients retreatment-free at 6 months. Favorable safety and no dose limited toxicity. The study enrolled 38 patients in China, aged 50-80 years of age with wet AMD (both treatment naïve and pre-treated). Patients were randomized 2:1 between 6mg dose (n=25) and 3 mg (n=13). Baseline characteristics were similar between both dose groups (noting a slightly higher proportion of pre-treated patients in the 6 mg dosing group). Dose level: 6 mg (n=25), 3 mg (n=13), Total (n=38). Age (years of age): Average 69.5 (6 mg), 71.5 (3 mg). Gender (%): Male/Female 68%/32% (6 mg), 61.5%/38.5% (3 mg), 65.8%/34.2% (Total). Mean Baseline BCVA (Letters): 54.7 (6 mg), 52.3 (3 mg), 53.9 (Total). Median Baseline CST (mm): 417.2 (6 mg), 407.6 (3 mg), 413.9 (Total). Prior Anti-VEGF Therapy (%): Yes/No 52%/48% (6 mg), 30.8%/69.2% (3 mg), 44.7%/55.3% (Total). VIS-101 demonstrated a favorable safety profile with no dose-limiting toxicity. The total treatment-related treatment emergent adverse events (TEAEs) were 0% (n=0) in the 3 mg dose and 8% (n=2) in the 6 mg dose, with 1 event each in two separate patients. The Phase 2a randomized study (NCT05456828) evaluated the safety and efficacy of VIS-101 (aka AM712 or ASKG712) in patients with wet AMD, including patients who were naïve to treatment or VEGF-experienced. The study enrolled a total of 38 wet AMD patients in China. Patients were randomized 2:1 to 6mg VIS-101 (n=25) or 3 mg VIS-101 (n=13). The primary endpoint was safety and pharmacokinetics and the secondary endpoint was efficacy, measured by best corrected visual acuity (BCVA) change from baseline (assessed by early treatment diabetic retinopathy scale (ETDRS Letters), change in central subfield thickness (CST, measured in mm), and retreatment rate. Subjects were given three loading doses at weeks 0, 4 and 8, with monthly follow-up to week 36 or retreatment (based on protocol-defined Disease Activity Criteria based on BCVA, CST and wet AMD activity). Safety and efficacy endpoints were assessed at each visit including 24 weeks (6 months) after the last loading dose. VIS-101 (also known as ASKG712 or AM712), purpose-designed to be best-in-class, is a dual VEGF-A X ANG-2 inhibitor in development for the treatment of retinal vascular diseases, such as wet AMD, diabetic macular edema (DME) and retinal vein occlusion (RVO), which affect more than 57 million people globally. VIS-101’s bispecific, tetravalent design format provides more binding sites and increased VEGF-A and ANG-2 affinity, for rapid, robust and class-leading durable responses. VIS-101 has completed initial safety and dose-escalation studies in both the US and China and a randomized, dose-ranging 2a study in China (NCT05456828). VIS-101 is expected to advance to a dose-determining Phase 2b study in 2026, with initiation of the global Phase 3 program in 2027.
