Innovent Biologics announces that the results of the phase 1 clinical trial of IBI302, a first-in-class ophthalmic recombinant human anti-VEGF and anti-complement bi-specific fusion protein for wet age-related macular degeneration (AMD) is released in e-poster at 2020 American Academy of Ophthalmology.
The phase 1 study of IBI302 is an open-label, multicenter, dose-escalation clinical trial to evaluate the safety and tolerability of a single intravitreal injection of IBI302 in patients with wet AMD.
A total of 31 subjects were enrolled in the completed phase 1 clinical study. All subjects received a single intravitreal injection of IBI302. No serious adverse event or dose limiting toxicity was reported. The study demonstrated good safety and tolerability of IBI302. One week after administration, improved vision and reduction of retinal edema were observed. By 28 days after administration, all 31 patients’ best corrected visual acuity increased by 6 letters on average compared to baseline; the average central retinal thickness decreased by 141.2 microns compared to baseline, and the efficacy of some patients lasted until 6 weeks after administration.
“Intravitreal injection of anti-VEGF drugs have become the first-line treatment for neovascular fundus diseases. Although they have a good therapeutic effect on nAMD in the short-term, a single anti-VEGF treatment regime requires frequent or even lifelong intraocular injections, and there are some patients with poor response or declining effect. Therefore, there are still huge unmet clinical needs in AMD treatment. The IBI302 phase 1 research has shown good safety and tolerability with promising effect. I believe and also look forward to the following research of IBI302 will show more positive results,” said the principal investigator Professor Xiaodong Sun from General Hospital affiliated to Shanghai Jiao Tong University.
“IBI302 is an innovative drug independently developed by Innovent for the treatment of fundus diseases. It is globally the first anti-VEGF/anti-complement bispecific molecule and has been supported by the major new drug project of the Ministry of Science and Technology as a Class 1 new drug. IBI302 was designed to provide more targeted treatment and interventions to the cause of AMD by adding additional targets, and to bring more clinical benefits compared to anti-VEGF antibody. The results presented by the current phase 1 clinical trial have brought us greater confidence in the next phase of IBI302 research and development. I hope that Innovent can benefit the majority of patients with fundus diseases and their families through more innovative targets and molecules,” said Dr. Lei Qian, Senior Medical Director of Department for Medical Science and Strategies of Special Disease of Innovent.