After unsheathing just a few months ago, Ollin Biosciences’ next-gen bispecific antibody cleared more disease faster than Genentech’s Vabysmo for patients with diabetic macular edema (DME) in an early-stage study.
Ollin is led by CEO and co-founder Jason Ehrlich, M.D., Ph.D., who previously worked at Roche's Genentech and contributed to the development of the blockbuster eye disease med Vabysmo (faricimab). With the recently-formed Ollin, Ehrlich set out to topple the titan—and it appears that his mission is on track.
Ollin’s phase 1b study, called Jade, examined the biotech’s VEGF/Ang2 bispecific antibody OLN324 versus faricimab among more than 160 patients with DME or wet age-related macular degeneration (wAMD).
Participants were split into three different treatment groups in which they received three monthly doses of either 2 mg of OLN324, 4 mg of OLN324 or 6 mg of faricimab.
At Week 12, almost 90% of DME patients receiving 4 mg of the investigational treatment achieved absence of disease, as compared to 57% of patients receiving faricimab, according to a Jan. 8 company release. Absence of DME was defined as central subfield thickness below 325 µm.
OLN324 was also tied to faster and greater retinal drying versus faricimab, with DME patients receiving the higher experimental dose experiencing 50% higher mean improvements in retinal drying compared to faricimab at Week 12, as measured by optical coherence tomography.
“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,” Arshad Khanani, M.D., director of clinical research at Sierra Eye Associates, JADE study investigator and Ollin scientific advisory board member, said in the release. “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.”
As to wAMD patients, all treatment groups saw “equivalent anatomic outcomes,” the company said, adding that patients in both DME and wAMD experienced numerically greater vision improvements than faricimab at 12 weeks.
Because the study is a phase 1 trial, the primary outcome measured the safety profile of OLN324, which Ollin described as “clean” and “favorable.” No cases of intraocular inflammation were reported in either investigational arm, though one case was recorded in the faricimab cohort. No cases of retinal vasculitis—inflammation of the blood cells in the retina—were reported.
Given the findings, the Texas-based biotech is planning to launch global phase 3 studies in both DME and wAMD this year.
“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,” Ollin CEO Ehrlich, said in the release.
“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,” Ehrlich added.
The biotech plans to discuss the study on Jan. 13 at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco. The study’s full findings are slated for presentation on Feb. 7 at an eye conference.
OLN324 was discovered by Innovent Biologics, a China biopharma company that Ollin is working with to develop the asset.
Ollin unveiled in September of last year with $100 million to push forward the antibody, which targets the same receptors as Vabysmo.
Ollin believes OLN324 tops Vabysmo given its higher potency for Ang2 and smaller size, which means it should more easily penetrate deeper into tissue after being injected.