News Release

RIBOMIC Completes Patient Enrollment of its US Phase 2 Clinical Trial of RBM-007for Wet

Age-Related Macular Degeneration (TOFU Study)

TOKYO, August 5, 2021 - RIBOMIC, Inc., a clinical stage pharmaceutical company specializing in aptamer therapeutics (TYO:4591), today announced that the patient enrollment is completed in Phase 2 trial (TOFU) of RBM-007 for the treatment of wet age-related macular degeneration (AMD) being conducted by its US subsidiary. The Company expects topline TOFU data to become available during the first quarter of 2022.

"Timely completion of the TOFU study enrollment, despite COVID-19 challenges, marks a significant milestone for RIBOMIC and an important step forward in the clinical development of RBM-007 for wet AMD. We believe RBM-007 has the potential to provide a novel and differentiated approach in the treatment of wet AMD and other retinal diseases," commented Padma Bezwada, PhD., CEO of RIBOMIC USA Inc. "We are grateful to the patients and thank the investigators and their study teams for participating in the trial. We look forward to the last enrolled patient to reach the study's primary endpoint in four months followed by data analysis and shortly after, sharing the top-line data. We hope that the data, if positive, could help inform the design of potential Phase 3 studies in wet AMD."

About RBM-007

RBM-007 is a novel oligonucleotide-based aptamer with potent anti-FGF2 (fibroblast growth factor 2) activity. FGF2 is implicated in not only angiogenesis but also fibrosis in several diseases including wet AMD., 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. In addition to the TOFU study, it is being investigated as a monotherapy in an extension trial RAMEN (NCT04640272) and in treatment naïve wet AMD patients in an IST, the TEMPURA study (NCT04895293)

About TOFU study

A Multi-Center, Randomized, Double Masked and Active Controlled Phase II 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 Age-related Macular Degeneration (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 Endpoint

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 Subjects

Approximately 81 (27 per arm)

Duration

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

Location

Approximately10 sites across the United States

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

About wet Age-related Macular Degeneration

Wet (exudative) age-related macular degeneration, is the leading cause of blindness in the United States and Europe. It is caused by the formation of abnormal and leaky new blood vessels under the retina, termed choroidal neovascularization. The leakage of fluid from the vessels causes retinal thickening and retinal degeneration including fibrotic scar formation, and leads to severe and rapid loss of vision.

ABOUT RIBOMIC

RIBOMIC is a clinical stage bio-venture company centered on drug discovery and development of aptamer therapeutics, which is one type of nucleic acid medicine, a field with much potential for the development of next-generation drugs. The RiboART system, the company's core drug discovery platform, can be used for the discovery of many types of aptamer drugs. RIBOMIC is dedicated to the discovery and development of drugs that target the broad field of unmet medical needs, which encompasses eye disorders, pain and many other diseases.

See RIBOMIC website for more information. https://www.ribomic.com/eng/

Forward-Looking Statements

This announcement contains forward-looking statements relating to current plans, estimates, strategies, belief and the future performance of Company. These statements are based on Company's current expectations in light of the information and assumptions currently available so that Company does not promise the realization and these expectations may differ materially from those discussed in the forward-looking statements. These factors include, but not limited to, i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets,

  1. currency exchange rate fluctuations, iii) claims and concerns on the product safety and efficacy, iv) completion and discontinuation of clinical trials, v) infringement of Company's intellectual property rights by third parties.
    Information on pharmaceutical products (including products currently in development), which is included in this press release is not intended to constitute an advertisement or medical advice.

"RIBOMIC," "RiboART system" and the RIBOMIC logo are registered trademarks or trademarks of RIBOMIC Inc. in various jurisdictions.

Contacts for inquiries or additional information: RIBOMIC Inc.

Finance and Accounting ir.inquiry@ribomic.com

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Ribomic Inc. published this content on 05 August 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 04 August 2021 23:05:03 UTC.