NovaBridge's VIS-101 Shows Promising Phase 2a Results in Wet AMD with Potential Best-in-Class Durability
核心洞察
NovaBridge and Visara (搜索) announced positive Phase 2a results for VIS-101 (搜索), a dual VEGF-A (搜索)/ANG-2 (搜索) inhibitor, showing mean visual acuity improvements of >10 ETDRS letters and median central subfield thickness reductions of 100-150 μm in wet AMD patients.
The study demonstrated potential best-in-class durability with approximately two-thirds of patients remaining retreatment-free at 4 months and half at 6 months, along with a favorable safety profile.
VIS-101 (搜索) is designed as a tetravalent, bispecific inhibitor targeting both VEGF-A (搜索) and ANG-2 (搜索) pathways for treating retinal vascular diseases affecting more than 57 million people globally.
NovaBridge Biosciences (搜索) and its subsidiary Visara (搜索) announced positive topline results from their Phase 2a study of VIS-101 (搜索), a purpose-designed dual VEGF-A (搜索)/ANG-2 (搜索) inhibitor for wet age-related macular degeneration (搜索) (wet AMD). The study demonstrated rapid, robust, and durable treatment responses with potential best-in-class durability and a favorable safety profile in a disease affecting more than 20 million people globally.
Strong Efficacy and Durability Profile
The Phase 2a study enrolled 38 patients in China, aged 50-80 years, with both treatment-naïve and pre-treated wet AMD patients. Participants were randomized 2:1 between 6mg (n=25) and 3mg (n=13) dose cohorts. Both dose groups demonstrated significant clinical improvements:
VIS-101 (搜索) produced mean improvements in Best Corrected Visual Acuity (BCVA) of greater than 10 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters and median central subfield thickness (CST) reductions of 100-150 μm. The treatment showed potential best-in-class durability, with approximately two-thirds of patients remaining retreatment-free at 4 months and nearly half maintaining this status at 6 months following three loading doses.
"The data clearly show that VIS-101 (搜索) produced rapid, robust and durable treatment responses, with favorable tolerability, after three loading doses," said Emmett T. Cunningham, Jr., MD, PhD, MPH, Founder and Executive Chairman of Visara (搜索). "Importantly, VIS-101 also demonstrated potential best-in-class durability, with nearly half of treatment naïve patients remaining retreatment free for more than six months following induction."
Favorable Safety Profile
The study demonstrated a favorable safety profile with no dose-limiting toxicity observed. Treatment-related treatment emergent adverse events (TEAEs) were 0% in the 3mg dose group and 8% (n=2) in the 6mg dose group, with one event each in two separate patients.
Novel Mechanism of Action
VIS-101 (搜索) is engineered as a tetravalent, bispecific dual VEGF-A (搜索)/ANG-2 (搜索) inhibitor designed to provide more potent and durable treatment benefits compared to current standard of care. The bispecific, tetravalent design format provides more binding sites and increased VEGF-A and ANG-2 affinity for rapid, robust, and potentially class-leading durable responses.
Carlos Quezada-Ruiz, MD, FASRS, Chairman of the Scientific Advisory Board of Visara (搜索), noted: "The combination of robust visual and anatomic improvements, with potentially best-in-class durability and a favorable safety profile shown to date by VIS-101 (搜索), has the potential to offer tangible benefits to people living with wet AMD and other retinal vascular diseases where the high treatment burden required by current therapies impacts their visual outcomes."
Clinical Context and Market Impact
Nikolas JS London, MD, FACS, Managing Partner and President of Retina Consultants San Diego, emphasized the clinical significance: "The widespread adoption of faricimab has firmly established dual VEGF-A (搜索)/ANG-2 (搜索) inhibition as the pathway forward for retinal vascular disease. Durability remains the greatest unmet need, and the Phase 2a data for VIS-101 (搜索) — with nearly half of treatment-naïve patients retreatment-free at six months after just three loading doses — is among the most encouraging I've seen at this stage."
Development Timeline and Strategy
Based on these positive results, Visara (搜索) plans to initiate a dose-determining Phase 2b study in the second half of 2026, followed by a global Phase 3 program in 2027. VIS-101 (搜索) is being developed for multiple retinal vascular diseases including wet AMD, diabetic macular edema (搜索) (DME), and retinal vein occlusion (搜索) (RVO), which collectively affect more than 57 million people globally.
Sean Fu, PhD, MBA, Chief Executive Officer of NovaBridge, stated: "The positive data reported today for VIS-101 (搜索) is an important inflection point for Visara (搜索), NovaBridge, and our investors. It further de-risks the development of VIS-101 and provides greater visibility to the value-creation potential of NovaBridge's global biotech platform."
Visara (搜索) holds global development and commercialization rights to VIS-101 (搜索) outside of Greater China and certain other Asian territories, which are licensed to Everest Medicines (搜索). NovaBridge is the majority shareholder of Visara, positioning the company to advance this potentially transformative therapy through late-stage development.