Innovent's anti-VEGF drug matches Eylea in phase 2 eye disease trial

2024-03-19

临床结果临床2期临床3期临床1期基因疗法

Innovent's anti-VEGF drug matches Eylea in phase 2 eye disease trial

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来源: FierceBiotech

Innovent will include a dosing cohort of every 16 weeks in the phase 3 STAR study of IBI302.

Innovent’s anti-VEGF drug held its own against Regeneron and Bayer’s blockbuster eye disease therapy Eylea in a phase 2 trial.

The study saw 132 participants with neovascular age-related macular degeneration (nAMD) randomized to receive either 6.4 mg or 8 mg doses of Innovent’s IBI302 or 2 mg of Eylea. Individuals on Eylea received their treatment every eight weeks, while those receiving IBI302 received treatment either every eight or 12 weeks depending on how they had responded to a loading therapy.

At 40 weeks, both doses of IBI302 were shown to have induced “non-inferior” improvements in best corrected visual acuity (BCVA) in the study eye from baseline when compared to the Eylea group, the study’s primary endpoint.

Specifically, the improvement from baseline on an eye test chart was 10.5 letters for the 6.4 mg IBI302 dose group, 11 letters for the 8 mg group and 9.8 letters for the Eylea group.

The study also looked at a change in the thickness of the retina. The 6.4 mg group saw a reduction of 163.19 μm, compared to 184.46 μm for the 8 mg group and 108.23 μm for the Eylea group at week 40.

Like Eylea, Innovent’s anti-VEGF contender also needs to be injected into the eye. The recommended dosing for Eylea is every four weeks for the first 12 weeks, and then every eight weeks.

However, Regeneron and Roche have been locked in a battle to bring down this injection burden. Roche launched Vabysmo as a longer-acting treatment to reduce dosing to just three times a year. In response, Regeneron launched Eylea 8 mg, which is marketed as Eylea HD.

Innovent is also keen to reduce the number of IBI302 injections. To this end, Innovent’s trial showed that around 81% and 88% of the 6.5 mg and 8 mg dose groups, respectively, were able to extend their dosing intervals from eight to 12 weeks.

As a result of the “excellent long-interval dosing performance” demonstrated by IBI302 in the phase 2 studies so far, Innovent will include a dosing cohort of every 16 weeks in the phase 3 STAR study of the drug—which would match the dosing regimen of Vabysmo.

“There are two major trends in drug development for nAMD: extending dosing intervals and reducing the occurrence of macular atrophy,” Lei Qian, vice president of Clinical Development at Innovent, said in today’s release. “In the results of two phase 2 studies, which enrolled over 360 subjects, IBI302 improved BCVA and macular edema in patients with nAMD significantly, extended dosing intervals, and had the potential to prevent the development of macular atrophy.”

Regeneron and Roche remain in a struggle to claim their respective treatments are the standard of care in macular degeneration. Innovent isn’t the only one chasing those Big Pharmas to reduce the burden of injections. Earlier this month, 4D Molecular Therapeutics linked a gene therapy to a 90% reduction in treatment burden in wet age-related macular degeneration. 4D’s adeno-associated virus vector delivers transgenes encoding aflibercept, the molecule that Regeneron sells as Eylea, and RNAi that inhibits VEGF-C.

The phase 2 win for IBI302 comes a month after another of Innovent’s potential eye disease drugs, IBI311, reported success against thyroid eye disease in a late-stage trial. The company is holding out hopes that the treatment will provide a first shot at the Chinese equivalent of a market that has already been conquered by Amgen’s Tepezza in the U.S.

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机构

Innovent Biologics, Inc.