Innovent announces first patient dosed in Phase 1 study of IBI324 in patients with diabetic macular edema

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According to the company, this Phase 1 dose escalations study will evaluate the safety and tolerability of intravitreal injection of IBI324 in subjects with DME.

Innovent Biologics Inc. announced that the first patient with diabetic macular edema (DME) has been dosed in the Phase 1 study of IBI324, a potential first-in-class ophthalmic recombinant human anti-VEGF-A and anti-Ang-2 bispecific antibody.

According to the company, this Phase 1 dose escalations study (CTR20221524) aims to evaluate the safety and tolerability of intravitreal injection of IBI324 in subjects with diabetic macular edema (DME).

The company also noted in a news release that IBI324 is a dual-target specific recombinant fully humanized anti-VEGF-A and anti-Ang-2 bispecific antibody developed by Innovent, which can achieve anti-angiogenesis, vascular stabilization and inflammation inhibition by blocking both VEGF-A and Ang-2, aiming to bring more potential clinical benefits to DME patients, such as prolonging the dosing interval and improving treatment compliance.

According to Xiaodong Sun, MD, vice president and director of the Eye Center of the First People’s Hospital of Shanghai Jiao Tong University, and principal investigator of the study, pointed out that anti-VEGF ophthalmic agents are now the standard of care for many neovascular fundus diseases.

“However, existing anti-VEGF drugs require repeated intravitreal injections every 4 to 12 weeks,” Sun said. “Frequent injections and follow-up reduce patient compliance with treatment, resulting in poor long-term treatment efficacy in many patients.

Sun also noted that persistent macular edema remains in approximately 40% of patients with DME under standard treatment.

“The multi-targeted agents based on anti-VEGF has become the current trend in drug development for fundus diseases,” Sun added. “We expect IBI324 to demonstrate positive safety and bioactivity results in the DME population by blocking both VEGF-A and Ang-2 targets and lengthen the dosing interval, leading to more options for clinical treatment."

Lei Qian, PhD, vice president of clinical development of Innovent, pointed out that IBI324 is an innovative molecule independently developed by Innovent for the treatment of fundus diseases.

“It is an anti-VEGF/ anti-Ang-2 bispecific antibody and another innovative dual-target molecule Innovent advances to clinic in the field of ophthalmology,” Qian said. “It deploys the global pioneering antibody design in the form of scFv (single-chain Fv) + VHH (single-domain antibody) and owns global intellectual property rights.”

Qian also noted that the results of preclinical studies showed the effect of IBI324 in inhibiting angiogenesis and reducing vascular leakage, indicating a potential advantage of a longer dosing interval compared with the competitors.

“The first-in-human Phase 1 study will evaluate the safety and tolerability of IBI324 in the patients with DME and provide solid ground for further clinical development,” Qian explained. “We look forward to further in-depth collaboration with experts in clinical and academia community to bring more potential innovative drugs to the clinic and ultimately benefit more patients and families.”