Innovent Biologics has dosed the first patient in the first-in-human Phase I clinical trial of IBI324 in patients with diabetic macular oedema (DME).

The dose escalations study will assess the safety and tolerability of intravitreal injection of IBI324 in DME patients.

An ophthalmic dual-target specific recombinant fully humanised recombinant human anti-VEGF-A and anti-Ang-2 bispecific antibody, IBI324 is developed by the company.

The N-terminus of the therapy can hinder the VEGF-A-facilitated signalling pathway and prevent vascular endothelial cell growth and proliferation, thereby averting angiogenesis and lowering vascular permeability and leakage.

Furthermore, the C-terminus is an Ang-2 binding domain that can prevent attaching of Ang-2 to the Tie-2 receptor. This could enhance the sensitivity to various other inflammatory factors, further stabilising blood vessels and preventing vascular leakage. 

IBI324 can also improve blood vessels, hinder neovascularisation and prevent VEGF-A and Ang-2-inflammation to offer further clinical benefits to DME patients.

According to findings from preclinical studies, IBI324 showed to hinder angiogenesis and lower vascular leakage, indicatinga possible benefit of an extended dosing interval versus the competitors. 

Innovent Clinical Development vice-president Dr Lei Qian said: “IBI324 is an innovative molecule independently developed by Innovent for the treatment of fundus diseases. 

“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.” 

Diabetic retinopathy is a complication of diabetes, caused by high blood sugar levels and damaging the retinal microvascular. 

A chronic progressive ailment, DME leads to impaired vision or even blindness caused by swelling of the retina’s central part. 

The latest development comes after the company and Laekna Therapeutics dosed the first participant in a Phase I/II trial of a three-drug combination therapy comprising afuresertib (LAE002), sintilimab (TYVYT) and chemotherapy for specific solid tumours.