KSI-501 has been designed for inhibiting two mechanisms, vascular endothelial growth factor and interleukin-6, implicated in retinal diseases. Credit: Sofie Zbořilová from Pixabay.

Biopharmaceutical company Kodiak Sciences has treated the first participant in the Phase I clinical trial of its investigational bispecific antibody biopolymer conjugate (ABC), KSI-501, for diabetic macular oedema (DME).

The open-label, multiple ascending dose Phase I clinical trial has been designed for assessing the tolerability, bioactivity, and safety of KSI-501 in these patients.

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It is currently enrolling participants in the US.

The trial’s primary objectives are to establish a maximum tolerated dose and assess the ocular and systemic safety of KSI-501.

The trap-antibody fusion biopolymer conjugate KSI-501 has been designed for inhibiting two mechanisms implicated in retinal diseases: vascular endothelial growth factor (VEGF) and interleukin-6 (IL-6), a pro-inflammatory cytokine and growth factor.

It is intended to provide potent inhibition of VEGF-mediated angiogenesis and vascular permeability through a soluble decoy receptor that inhibits the VEGF-A and PLGF binding to their cognate receptors.

KSI-501 also offers IL-6-mediated inflammation inhibition through an antibody that binds soluble interleukin-6, inhibiting its binding to soluble as well as membrane-bound IL-6 receptors.

Kodiak Sciences chief medical officer and chief development officer Jason Ehrlich said: “IL-6 is a pro-inflammatory cytokine and growth factor implicated in the pathophysiology of multiple retinal diseases and, in conditions for which anti-VEGF treatment is used, elevated levels of ocular IL-6 have been associated with poor anti-VEGF treatment response.

“We believe KSI-501 represents a new category of retinal medicine, uniquely designed to provide potent inhibition of both VEGF-mediated vascular permeability and IL-6 mediated inflammation in a single bispecific molecule and also with the benefits of extended durability enabled by our ABC Platform.

“Our Phase I study of KSI-501 will initially focus on establishing safety in patients with DME, a disease known for its high levels of microvascular inflammation, and we anticipate broadening the spectrum of diseases under study once dose escalation is complete.”