02.19.20

Ribomic Announces First Injection in the Phase 2 Clinical Trial of RBM-007 (TOFU Study) in Subjects with Wet AMD

Source: Ribomic

Ribomic announced that first patient has received injection in the phase 2 trial of RBM-007 for the treatment of wet age-related macular degeneration (AMD) in the United States. The first site started enrollment at the end of December 2019 and five sites are now active across the United States.

RBM-007 is a novel oligonucleotide-based aptamer with potent anti-FGF2 (fibroblast growth factor 2) activity. Currently approved therapies for wet AMD—intravitreal injections of anti-VEGF drugs—have shown dramatic visual benefits for wet AMD patients. However, a significant portion of wet AMD patients exhibit incomplete response to therapy, and over the extended management course can lose vision, with the formation of submacular fibrosis as one risk factor. Ribomic investigated a novel therapy for wet AMD targeting fibroblast growth factor 2 (FGF2), which is implicated in not only angiogenesis but also fibrosis in several diseases, and created RBM-007, a novel oligonucleotide-based aptamer with potent anti-FGF2 activity. RBM-007 is chemically synthesized, and pharmacokinetic studies of RBM-007 in the rabbit vitreous revealed high and relatively long-lasting profiles, which are superior to the other approved anti-VEGF drugs. The dual action of RBM-007 (anti-angiogenic and anti-scarring) holds promise as an additive or alternative therapy to anti-VEGF treatments for wet AMD.

About TOFU study

A multicenter, randomized, double masked and active controlled phase 2 study assessing the efficacy and safety of intravitreal injections of RBM-007 monotherapy and RBM-007 in combination with Eylea compared to Eylea monotherapy in subjects with wet AMD (TOFU Study) is phase 2 study assessing the safety, efficacy and durability of RBM-007.

Study Design

Multicenter, active-controlled, double masked study

Patient Population

Patients with wet AMD who are non or low responders to existing anti-VEGF drugs

Administration

Four monthly intravitreal injections of RBM-007. Eylea dosed every other month as per label.

Primary Endpoints

Mean change in Best Corrected Visual Acuity from Baseline and safety

Study Arms

RBM-007 (monotherapy)
RBM-007 and Eylea (Anti-VEGF drug) (combination)
Eylea (Anti-VEGF drug) (monotherapy)

Number of Subject

81 (27 per arm)

Duration

5 months (primary endpoint at month 1 after last injection)

Location

10 or more sites across the United States

See ClinicalTrials.gov for more information.
https://clinicaltrials.gov/ct2/show/NCT04200248

 

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