Ollin Biosciences, a clinical-stage biotech developing therapies for vision-threatening diseases, has announced that its next-generation VEGF/Ang2 bispecific antibody, OLN324, delivered superior results compared to faricimab (Vabysmo) in a trial.
The randomized, head-to-head Phase 1b JADE trial involved over 160 patients with diabetic macular edema (DME) or wet age-related macular degeneration (wAMD).
OLN324’s design—featuring up to 60-fold higher anti-Ang2 potency, a smaller protein format, and a higher molar dose—gave it a differentiated profile that could set a new first-line standard of care.
In patients with DME, OLN324 showed faster and greater retinal drying. Week 1 improvements in central subfield thickness (CST) were roughly 75% greater than faricimab (and by Week 12, OLN324 maintained a ~50% advantage. Nearly 90% of patients treated with OLN324 4 mg achieved absence of DME at Week 12, compared to 57% with faricimab.
In wAMD patients, all treatment groups saw rapid improvements in retinal thickness, sustained through Week 12. Vision gains, measured as best-corrected visual acuity (BCVA), were rapid and sustained across all groups, with OLN324 showing numerically higher improvements at Week 12 in both DME and wAMD.
“OLN324 is the first and only therapy to demonstrate superior anatomic efficacy compared to the market leader, faricimab, in a head-to-head, randomized clinical trial,” said Jason Ehrlich, Co-founder and CEO of Ollin Biosciences.
“These data validate that a higher potency, higher molar dose, smaller format VEGF/Ang2 bispecific can more fully realize the therapeutic potential of dual VEGF and Ang2 inhibition. By achieving faster and greater retinal drying in DME, OLN324 has the potential to become the new standard of care in the ~$15 billion worldwide market for retinal therapeutics.”
“DME is among the most challenging retinal diseases to treat and has long served as a proving ground for therapies that ultimately become first-line standard of care in retinal diseases. The difference in speed and extent of retinal drying observed with OLN324 versus faricimab, the highest bar comparator in DME, is compelling and clinically significant.
"In real-world practice, this best-in-disease outcome could lead to broad utility for OLN324 across all the major retinal diseases,” said Arshad M. Khanani, Managing Partner and Director of Clinical Research at Sierra Eye Associates, JADE study investigator and Ollin Scientific Advisory Board member.
“We are excited about the progress of OLN324 (IBI324), driven forward by our partner Ollin —especially the successful results of the JADE Phase 1b trial in head-to-head comparison with faricimab,” stated Dr.Lei Qian, Chief R&D Officer of General Biomedicine of Innovent Biologics.
“As a next-generation VEGF/Ang-2 bispecific antibody, OLN324 holds the potential to deliver differentiated clinical value for patients with retinal diseases. We look forward to continuing our close collaboration with Ollin to accelerate the global development of this best-in-disease drug.”
Dr Ehrlich added, “We look forward to discussing these data with health authorities and moving OLN324 quickly into global Phase 3 studies in both DME and wet AMD.”
