RIBOMIC Announces Preliminary Topline Data From Phase 2 Trials of RBM-007 for Wet Age-Related Macular Degeneration
TOKYO: RIBOMIC, Inc., a clinical stage pharmaceutical company specializing in aptamer therapeutics (TOKYO:4591), has announced the topline data from the Phase 2 TOFU study of RBM-007 in patients with Wet Age-Related Macular Degeneration (wAMD).
TOFU study is a double-masked, randomized, active-controlled Phase 2 trial (n=86) evaluating the efficacy and safety of RBM-007 monotherapy and RBM-007 in combination with Eylea® compared to Eylea® monotherapy in patients with wAMD who are previously treated with Standard of Care (anti-VEGF drugs).
As a result of the analysis, RBM-007 monotherapy or RBM-007 in combination with Eylea® did not demonstrate vision improvement over Eylea® monotherapy in this patient population.
On the other hand, in treatment naïve wAMD patients, preliminary interim data from the ongoing phase 2 TEMPURA investigator sponsored trial evaluating the safety and efficacy of RBM-007 monotherapy are showing improvement in vision and retinal anatomy.
Additional analyses of secondary endpoints of TOFU are ongoing. The company is planning to share the detailed results together with those from its RAMEN extension study and TEMPURA study as full dataset.
