News Release
RIBOMIC Announces First Patient Dosed in an Investigator Sponsored Trial of RBM- 007 in treatment naïve wet AMD Patients
TOKYO, July 12, 2021 - RIBOMIC, Inc., a clinical stage pharmaceutical company specializing in aptamer therapeutics (TYO:4591), announced today that the first subject has been dosed in a phase 2 investigator sponsored trial (IST) - named 'TEMPURA Study' for wet AMD. The TEMPURA IST (NCT04895293) is being conducted by Dr. Raj K. Maturi M.D. P.C at the Midwest Eye Institute, Indiana. The open labelled clinical trial is enrolling patients with intraretinal or subretinal edema due to previously untreated neovascular AMD. The study has been designed to assess the safety and efficacy of intravitreal injections of RBM-007 in treatment naïve patients
Dr. Maturi commented "Excited to see the potential benefits of new mechanism of action in wet AMD".
Dr. Padma Bezwada, CEO of RIBOMIC USA Inc, added "We congratulate Dr. Maturi on achieving the important milestone of first patient dosed in the IST and are pleased to support the efforts of Dr. Maturi and his team. We believe the trial will provide great insights into RBM-007 activity in treatment naïve exudative AMD and hope that RBM-007 with its dual anti-angiogenic and anti-fibrotic activity can prove beneficial in the treatment of 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. It is currently being investigated as a monotherapy and in combination with Eylea in patients with wet AMD in a P2 clinical trial (TOFU study NCT04200248) and an extension study of NCT04200248 assessing the efficacy and safety of additional intravitreal injections of RBM-007 (RAMEN Study NCT04640272)
About TEMPURA study
Study Title | Evaluation of RBM-007 in Subjects with Treatment naïve |
Exudative Age-related Macular Degeneration | |
Study Design | open-label study |
Patient Population | Wet AMD patients without prior treatment of wet AMD |
Administration | Three monthly intravitreal injections of RBM-007 |
Primary Endpoints | Change in central subfield thickness |
Key Secondary | Change in Best Corrected Visual Acuity |
Endpoints | |
Study Arms | RBM-007 (2.0 mg) |
Number of Subject | 5 |
Duration | 4 months (primary endpoint at month 1 after last injection) |
See ClinicalTrials.gov for more details https://clinicaltrials.gov/ct2/show/NCT04895293?term=NCT04895293&draw=2&rank=1
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, ii) 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.
Administration Division ir.inquiry@ribomic.com
Attachments
- Original document
- Permalink
Disclaimer
Ribomic Inc. published this content on 12 July 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 12 July 2021 06:01:06 UTC.