First patient dosed in phase 1 study of IBI324 for 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.

The Phase 1 dose escalations study (CTR20221524) aims to evaluate the safety and tolerability of intravitreal injection of IBI324 in subjects with DME, according to a news release.

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, the company stated. It aims 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 stated, in the release. “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 stated in the release. “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 stated.