RIBOMIC publishes data on Phase 1 and Phase 2 studies of umedaptanib pegol for nAMD

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RIBOMIC Inc. announced the publication of the full results from the phase 1 (SUSHI)¹ and phase 2 (TOFU/RAMEN/TEMPURA)² trials evaluating the efficacy and safety of intravitreal umedaptanib pegol in nAMD in Eye.

The phase 2 trials are as follows:

• TOFU is a randomized, double-masked study assessing the efficacy of intravitreal umedaptanib pegol monotherapy or in combination with Eylea®, compared to Eylea® monotherapy in 86 subjects with anti-VEGF pretreated nAMD.
• RAMEN is an extension study of TOFU, in which 22 subjects who had exited the TOFU study received 4 monthly intravitreal injections of umedaptanib pegol.
• TEMPURA is an investigator-sponsored, single-center, open-label, 4-month study of umedaptanib pegol in five treatment-naïve nAMD patients.³

The outcomes of these studies showed that umedaptanib pegol was safe, well -olerated, and effective in treating patients with nAMD who had no or short history of anti-VEGF treatment. Researchers saw improvements in visual acuity and anatomy in some of the treatment naïve patients. Patients with a long history of anti-VEGF treatment for nAMD showed no additional benefit of umedaptanib pegol monotherapy or the combination over Eylea®. However, the pre-existing fibrosis remained stable and did not worsen throughout the course of these studies.³

Visual acuity decreased slightly in patients who switched from anti-VEGF (Eylea®) to umedaptanib pegol in the RAMEN study. This has led the company to believe that umedaptanib pegol can be used as an alternative first-line medication before patients are exposed to anti-VEGF treatments to mitigate risk of damage caused by fibrosis. The company also notes that further studies are needed on the efficacy of umedaptanib pegol early in the onset of nAMD as well as in coordination or combination with anti-VEGF drugs.³

Yoshi Nakamura, PhD, CEO of RIBOMIC Inc, shared thoughts on the results in the press release, saying “We are very pleased that The Royal College of Ophthalmologists journal (Eye) recognized the trial results as a viable Proof-of-Concept for umedaptanib pegol in nAMD therapy. This first clinical evidence News Release is an exciting breakthrough which raises hope that a non-VEGF target can lead to successful monotherapy in nAMD and provide a first-line alternative to treatment naïve nAMD patients.”³

Reference:

1. Pereira, D.S., Akita, K., Bhisitkul, R.B., Nishihata, T., Ali, Y., Nakamura, E., Nakamura, Y.: Safety and tolerability of intravitreal umedaptanib pegol (anti-FGF2) for neovascular age-related macular degeneration (nAMD): a phase 1, open label study. Eye, published online: December 1, 2023. https://www.nature.com/articles/s41433-023-02849-6.pdf

2. Pereira, D.S., Maturi, R.K., Akita, K., Bhisitkul, R.B., Nishihata, T., Sakota, E., Ali, Y., Nakamura, E., Bezwada, P., Nakamura, Y.: Clinical proof of concept for anti-FGF2 therapy in exudative age-related macular degeneration (nAMD): phase 2 trials in treatment-naïve and anti-VEGF pretreated patients. Eye, published online: November 30, 2023. https://www.nature.com/articles/s41433-023-02848- 7.pdf

3. RIBOMIC Phase I and II Data Published in the Eye: Full TOFU/RAMEN/TEMPURA Trial Results Demonstrate Clinical Proof of Concept of Umedaptanib Pegol in Exudative Age-Related Macular Degeneration (nAMD). RIBOMIC Inc. December 4, 2023. Accessed December 12, 2023. https://ssl4.eir-parts.net/doc/4591/ir_material3/219444/00.pdf