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.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
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.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataKSI-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.”
