FX.co ★ Innovent : Phase 2 Trial Of IBI302 In Neovascular Age-related Macular Degeneration Meets Main Goal

Innovent Biologics Inc. has announced the successful completion of the second Phase 2 clinical trial evaluating efdamrofusp alfa high-dose (working development code: IBI302), a recombinant human VEGFR-Fc-Human CR1 fusion protein injection, in Chinese patients suffering from neovascular age-related macular degeneration.

The results from the two Phase 2 trials, which involved more than 360 subjects suffering from this type of macular degeneration, suggested that IBI302 could be administered at 12-week intervals. Results indicated it offered stable and reliable visual benefits, along with improvements in eye structure and potential inhibitory effects on macular atrophy. Encouraged by these impressive results, Innovent decided to push forward IBI302 8mg into a Phase 3 study, named STAR, in October 2023.

The company revealed that the primary endpoint was effectively achieved. By the 40-week mark, patients in the IBI302 6.4 mg and 8.0 mg groups displayed non-inferior BCVA gains compared to those in the Aflibercept 2.0 mg group. On average, BCVA improvements from baseline were reported as 10.5 ETDRS letters for the IBI302 6.4 mg cohort, 11.0 ETDRS letters for the 8.0 mg cohort, and 9.8 ETDRS letters for the Aflibercept 2.0 mg group at the 40-week point.

Furthermore, around 81% and 88% of patients in the 6.4mg and 8.0mg IBI302 groups respectively were able to extend the dosing period to Q12W. It mirrored the proportions of patients achieving Q12W or longer dosing intervals with Aflibercept 8.0 mg (83% in the PULSAR trial) or Faricimab (79.7% and 77.8% in the TENAYA & LUCERNE trials respectively).

The team found the overall safety profile of IBI302 to be very good. It was found comparable to that of Aflibercept 2.0 mg and aligned with results from previous studies. No new safety concerns were flagged.

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