According to the company, a change from base line best corrected visual acuity based on an average at week 44, 48 and 52 serves as the primary endpoint.
Innovent Biologics Inc. has dosed the first patient diagnosed with neovascular age-related macular degeneration in the STAR Phase 3 clinical study of efdamrofusp alfa (IBI302), a recombinant fully human anti-VEGF and anti-complement bispecific fusion protein.
According to the company, STAR is a randomized, double-masked, active-controlled Phase 3 clinical study to evaluate the efficacy and safety of intravitreal 8 mg IBI302 in subjects with nAMD to support the potential new drug application for IBI302 (NCT05972473).
Lei Qian, vice president of clinical development of Innovent, pointed out in a news release IBI302, as the first anti-VEGF and anti-complement bispecific molecule, is an innovative drug of Innovent with global proprietary right for the treatment of fundus diseases.
“The preliminary results of the Phase 1 and Phase 2 clinical studies have demonstrated a favorable safety and efficacy profile, we are encouraged to advance it into next stage of development,” Qian said in the news release. “In the STAR study, our focus will not only be on improvement of visual acuity and retinal thickness but also on exploring the efficacy of 8mg IBI302 in extended dosing intervals. We look forward to the success of IBI302 in the STAR Phase 3 trial, to provide patients with a more effective and safe clinical treatment regimen as soon as possible."
The company noted in the news release a total of 600 subjects will be enrolled and randomly assigned to 8mg IBI302 arm and 2mg aflibercept arm in a 1:1 ratio. All subjects will have visits every 4 weeks (Q4W) for the entire study duration. Subjects assigned to IBI302 arm will receive 8mg IBI302 intravitreal injections (Q4W) up to week 8, followed by 8mg IBI302 intravitreal injections according to a personalized treatment intervals (PTI) dosing regimen. Subjects randomized to the aflibercept active control arm will receive 2mg aflibercept intravitreal (Q4W) up to week 8, followed by 2mg aflibercept intravitreal (Q8W).
The primary endpoint of the STAR trial is change from baseline in best corrected visual acuity (BCVA) letters in the study eye based on an average at week 44, 48, and 52. All subjects will continue to receive intravitreal injections up to week 96, with a final study visit at week 100.
The company noted in its news release IBI302 is a bispecific fusion protein targeting VEGF and complement, can simultaneously inhibit VEGF-mediated signaling pathways and attenuate inflammatory responses mediated by complement activation.
Moreover, company officials pointed out the results of the two Phase 2 clinical studies have demonstrated the favorable safety and efficacy of IBI302 in patients with nAMD, as well as the advantages of long-interval dosing: in terms of efficacy, improvements in BCVA, retinal thickness, and leakage and total area of neovascularization, with potential improvements in macular atrophy and fibrosis have been observed. The company also noted in its news release that overall safety profile was favorable and similar to existing anti-VEGF agents.
Xiaodong Sun, MD, PhD, deputy director of Shanghai General Hospital, Head of Ophthalmology Centre, Principal Investigator of the study, noted anti-VEGF drugs are the first-line treatment for nAMD.
“This treatment is associated with several limitations, such as frequent injections, long-term efficacy attenuation, and suboptimal outcomes for some patients, imposing significant inconvenience and economic burden to the majority of patients,” Sun said in the news release. “Therefore, there remains a significant unmet clinical need.”
Sun also pointed out IBI302, as a global first-in-class anti VEGF-complement dual targeting drug, has demonstrated promising efficacy signals in completed Phase 1 and Phase 2 clinical studies, including improvements in visual acuity and reduction in retinal edema, while exhibiting favorable safety profiles.
“Preliminary positive signals have also been observed in the inhibition of fibrosis and macular atrophy,” Sun said in the release. “This has instilled great confidence in our researchers.”
Sun added the company is looking forward to the upcoming Phase III STAR trial, with hope that IBI302 will not only overcome the current treatment limitations, prolong dosing intervals, reducing the burden of injections on patients, but also demonstrate its potential advantages in long-term anti fibrosis and macular atrophy improvement.
“This will ultimately offer a more patient-friendly dosing regimen and longer-lasting visual benefits to patients,” Sun said in the statement.