Regeneron (NSDQ:REGN) is scrapping plans for a new combination drug pairing its Eylea with angiopoietin2 antibody nesvacumab after disappointing results from mid-stage clinical trials, according to a press release it published on Monday.
Regeneron received results from 2 Phase 2 trials, the Ruby and Onyx studies, which reported that the combination drug “did not provide sufficient differentiation to warrant Phase 3 development,” the company said.
“We knew from the start that it would be difficult to improve on the already high bar set by Eylea, which is the market leading branded therapy in its approved indications, providing significant improvements in vision and strong long-term outcomes in patients with wet AMD and DME. We expect to report results in the first half of 2018 from our Eylea Phase 3 study in diabetic retinopathy, which represents a growing patient population with significant need. We also continue to invest in additional R&D approaches in ophthalmology with the goal of providing new innovations to patients with serious vision-threatening diseases,” prez & chief sceintific officer Dr. George Yancopoulos
The Ruby and Onyx trials were randomized, double-masked, active-controlled phase 2 studies looking to investigate whether the combination drug offered additonal benefit over Eylea alone, and evaluated different doses of nesvacumab in combination with Eylea.
The primary endpoint for both trials was change in best-corrected visual acquity between weeks 12 and 36 as measured by the Early Treatment Diabetic Retinopathy Study letter score. Regeneron said it will further analyze results from the studies, according to a press release.
In September, Sanofi (NYSE:SNY) and Regeneron touted data from the pivotal Phase III trial of dupilumab in a group of patients with uncontrolled, persistent asthma.
