Innovent phase 2 wet AMD treatment trial meets primary endpoint
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Key takeaways:
- The primary endpoint was the change in best corrected visual acuity from baseline to week 40.
- Most patients who received IBI302 were able to extend dosing to every 12 weeks.
Patients with neovascular age-related macular degeneration experienced visual benefits and anatomic improvements with extended dosing intervals of IBI302, according to a press release from Innovent Biologics.
In a second phase 2 clinical trial of intravitreal IBI302 (efdamrofusp alfa), a recombinant fully human bispecific fusion protein, 132 Chinese patients were randomly assigned to receive IBI302 6.4 mg, IBI302 8 mg or aflibercept 2 mg. Dosing intervals for IBI302 were adjusted depending on the response to the loading therapy.
The primary endpoint of the 52-week study was the change in best corrected visual acuity in the study eye from baseline to week 40. The study reached that endpoint at week 40, with patients in both IBI302 groups showing noninferior BCVA gains vs. the aflibercept group. The mean BCVA improvement was 11 ETDRS letters in the 8 mg group and 10.5 letters in the 6.4 mg group compared with 9.8 letters in the aflibercept group. Patients also experienced a decrease in central subfield thickness.
Eighty-one percent of patients in the 6.4 mg group and 88% of patients in the 8 mg group were able to extend dosing to every 12 weeks. Based on this, Innovent added an every 16 week dosing interval regimen to the phase 3 STAR clinical study of IBI302 8 mg.
The safety profile of IBI302 was favorable, and the study identified no new safety signals.
“In the results of two phase 2 studies, which enrolled over 360 subjects, IBI302 improved BCVA and macular edema in patients with [neovascular] AMD significantly, extended dosing intervals and had the potential to prevent the development of macular atrophy,” Lei Qian, MD, PhD, Innovent vice president of clinical development, said in the release.
“Next, we will further investigate the long-interval dosing efficacy and safety of high-dose IBI302 in the phase 3 STAR trial, hoping to bring a new generation of anti-VEGF agents to patients with [neovascular] AMD.”
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