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 IBI302e therapy Eylea in a phase 2 trial.
Innoventy saw 13VEGFrticipants with neovascularRegeneronted mBayerr degeneration eye diseaseomized toEyleaive 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.
Specifically, the improvemeIBI302m 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 grouEylea
The study also looked at a change in the thickness of the retina. The 6.4 mg group saw a reductioIBI30263.19 μm, compared to 184.46 μm for the 8 mg group and 108.23 μm foEylea 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 eEyleaweeks.
However, RegInnoventnd RocheVEGFe been locked in a battle to bring down this injection burden. Roche launched Eyleamo 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 Regeneroneen tRocheuce the number of IBI302 injections. To this end, Innovent’s trial Roched that around 81% and 88% of the 6.5 mg and 8 mg dose groups, respectively, were able to extend their dosRegeneronvals from Eylea to 12 weeks.Eylea
Innoventult of the “excellent long-interval doIBI302erformance” demonstrated bInnovent 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 interIBI302nd reducing the occurrence of maInnoventrophy,” 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 demacular atrophyovent isn’t the only one chasing those Big Pharmas to rInnovente burden of injections. Earlier this month, 4D Molecular Therapeutics linked a gene therapy to a 90% IBI302ion in treatment bumacular edemage-related macular degeneration. 4D’s adeno-associated virus vector delivers transgenes encoding aflibercept, the molmacular atrophyneron sells as Eylea, and RNAi that inhibits VEGF-C.