Innovent Biologics has dosed the first patient in the Phase III STAR clinical study of efdamrofusp alfa (IBI302) to treat neovascular age-related macular degeneration (nAMD).
The active-controlled, double-masked, randomised study is designed to assess the safety and efficacy of the recombinant fully human anti-VEGF and anti-complement bispecific fusion protein IBI302 in nAMD subjects.
It will enrol and randomise a total of 600 subjects into a 1:1 ratio to receive 8mg IBI302 and 2mg aflibercept via intravitreal injections.
Subjects in the IBI302 arm will receive 8mg IBI302 every four weeks (Q4W) up to week 8 and according to a personalised treatment intervals (PTI) dosing regimen, they will further receive the same dose.
The active control arm will receive 2mg aflibercept in Q4W up to week 8 followed by the same dose every eight weeks (Q8W).
Change from baseline in best corrected visual acuity (BCVA) letters in the study eye, based on an average at weeks 44, 48 and 52, is the primary endpoint of the study.
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All the subjects will receive intravitreal injections up to week 96, with a final study visit at week 100.
Innovent Biologics Clinical Development vice-president Dr Lei Qian said: “As globally the first anti-VEGF and anti-complement bispecific molecule, IBI302 is an innovative drug of Innovent with global proprietary right for the treatment of fundus diseases.
“The preliminary results of the Phase I and Phase II clinical studies have demonstrated a favourable safety and efficacy profile; we are encouraged to advance it into next stage of development.
“We look forward to the success of IBI302 in the STAR Phase III trial to provide patients with a more effective and safe clinical treatment regimen as soon as possible.”
The company is also engaged in developing, manufacturing and commercialising new therapeutics for cardiovascular, autoimmune, metabolic and oncology diseases.