Vantage Biosciences Doses First Patient in Phase 2 Trial of VX-01

Vantage Biosciences has officially dosed the first patient in its Phase 2 clinical trial evaluating VX-01, an investigational oral treatment for non-proliferative diabetic retinopathy (NPDR).

Overview of the VX-01 Phase 2 Study

The trial, designated VX01-DR-201, is a Phase 2, multi-center, double-masked, randomized, placebo-controlled study aimed at assessing the efficacy of VX-01 in patients diagnosed with moderate to severe NPDR without center-involved diabetic macular edema (CI-DME).

Patients enrolled in the study will be randomized 1:1 into two cohorts: one receiving VX-01 and the other placebo. The treatment regimen involves twice-daily (BID) oral dosing for 52 consecutive weeks, followed by a 12-week post-treatment observation period to monitor long-term outcomes.

Mechanism of Action: Addressing Neurovascular Inflammation

VX-01 is a small molecule oral therapy specifically designed to target neurovascular inflammation, a key pathological process in diabetic eye disease. The goal of this therapeutic approach is to slow or prevent the progression of NPDR, potentially offering a preventive strategy before irreversible vision loss occurs.

Statement from Vantage Biosciences Leadership

Alek Safarian, co-founder and chairman of Vantage Biosciences, expressed optimism about the study in the company’s official press release:

“We are pleased to initiate patient dosing in this important phase 2 study, which evaluates VX-01 as a potential early intervention for diabetic retinopathy. By targeting the disease at an earlier stage, VX-01 has the potential to slow or prevent progression to more severe forms of diabetic retinopathy, reducing the likelihood that patients will require invasive treatments in the future.”

Global Study Locations and Timeline

The VX01-DR-201 study is being conducted at 27 clinical sites across the United States, Australia, and several countries in Southeast Asia. According to Vantage Biosciences, study results are anticipated in 2027, marking a significant milestone in the development timeline for VX-01.