Innovent Biologics Initiates Phase 3 Clinical Study for Potential Treatment of Age-Related Macular Degeneration

Innovent Biologics, a leading biopharmaceutical company, has announced the successful dosing of the first patient in the Phase 3 clinical study of efdamrofusp alfa (IBI302) for the treatment of neovascular age-related macular degeneration (nAMD). The study, known as STAR, aims to evaluate the efficacy and safety of IBI302 in subjects with nAMD.

nAMD is a chronic ocular disease that affects the macula of the retina, leading to central visual impairment. It is the leading cause of central vision loss in AMD patients over 65 years of age. Current treatments for nAMD, such as anti-VEGF drugs, have limitations including frequent injections and long-term efficacy attenuation.

IBI302 is a first-in-class bispecific fusion protein that targets both VEGF and complement, simultaneously inhibiting VEGF-mediated signaling pathways and attenuating inflammatory responses. Previous Phase 2 clinical studies have shown promising safety and efficacy results, including improvements in visual acuity and reduction in retinal edema.

The STAR study will enroll 600 subjects who will be randomized to receive either 8mg IBI302 or 2mg aflibercept, an active control. The primary endpoint of the study is the change from baseline in best corrected visual acuity (BCVA) letters. All subjects will continue to receive intravitreal injections up to Week 96, with a final study visit at Week 100.

Professor Xiaodong Sun, the Principal Investigator of the study, highlighted the significant unmet clinical need for nAMD treatment and expressed confidence in the potential of IBI302 to address the limitations of current therapies. The Phase 3 trial aims to provide a more effective and patient-friendly dosing regimen, offering longer-lasting visual benefits.

Dr. Lei Qian, Vice President of Clinical Development at Innovent, emphasized the innovative nature of IBI302 as a global first-in-class anti-VEGF-complement dual targeting drug. The company is committed to advancing the development of IBI302 and exploring extended dosing intervals to provide patients with a more effective and safe treatment option.

Innovent Biologics is dedicated to developing high-quality biopharmaceutical products for the treatment of various diseases. With a strong pipeline of innovative medicines, the company aims to enhance the quality of patients’ lives.