RIBOMIC confirms positive results from SUSHI study in wet AMD patients
Category: #health  By Mateen Dalal  Date: 2019-06-19
  • share
  • Twitter
  • Facebook
  • LinkedIn

RIBOMIC confirms positive results from SUSHI study in wet AMD patients
  • Phase 1/2a trial of RBM-007 was successfully conducted, yielding top-line results
     
  • Seven out of nine subjects showed a considerable improvement in Central Retinal Thickness

Clinical stage pharmaceutical company RIBOMIC has recently unveiled positive top-line results from its SUSHI study, a Phase 1/2a single ascending dose trial of anti-FGF2 aptamer RBM-007, in nine patients with wet Age-Related Macular Degeneration (wet AMD).

Apparently, subjects enrolled for the SUSHI study had been diagnosed with wet AMD that showed very little response to the previously given intravitreal anti-VEGF treatment. Secondary results at the end of the primary study endpoint of 28 days showed notable indication regarding bioactivity of RBM-007.

Seven out of nine patients responded to RBM-007, in terms of Best-Corrected Visual Acuity (BCVA) or ≥50 µm progress in Central Retinal Thickness on optical coherence tomography (OCT), reports suggested.

Reportedly, wet age-Related Macular Degeneration (AMD) accounts for a major cause of blindness in the United States and Europe. The condition involves formation of anomalous and leaky new blood vessels beneath the retina, known as choroidal neovascularization. The leakage of fluid from vessels causes severe and rapid loss of vision.

RBM-007 is an oligonucleotide-based aptamer with potent anti-FGF2 (fibroblast growth factor 2) activity. Subjects’ eyes were administered with a single injection of RBM-007 in three subsequent dose cohorts (3 subjects/cohort): 0.2 mg (Cohort 1), 1.0 mg (Cohort 2) and 2.0 mg (Cohort 3). The primary study was concluded at Day 28, with follow-up through Day 56.

Yoshikazu Nakamura, CEO and president, RIBOMIC Inc., was reportedly quoted saying that they were very encouraged by the results of SUSHI study. It was designed as a first-in-human, single-dose safety study and had surpassed their expectations from the standpoint of bioactivity.

Yusuf Ali, CEO, RIBOMIC USA Inc., said SUSHI study had demonstrated that single dose of intravitreal RBM-007 up to 2 mg dose was well-tolerated in subjects with wet AMD, as showcased  by clinical efficacy in several subjects as measured by BCVA and OCT thickness. This suggests FGF2 was an important target in the pathogenesis of wet AMD.

 

Source Credits:  https://www.businesswire.com/news/home/20190617005273/en/RIBOMIC-Announces-Positive-Top-Line-Results-Phase-12a

  • share
  • Twitter
  • Facebook
  • LinkedIn


About Author

Mateen Dalal    

Mateen Dalal

A qualified electronics and telecommunication engineer, Mateen Dalal embarked on his professional journey working as a quality and test engineer. Harnessing his passion for content creation however, Mateen pens down industry-rich articles for ReportsGO.com and a few o...

Read More

More News By Mateen Dalal

AstraZeneca to present results of Farxiga’s DAPA-CKD trial at ESC 2020
AstraZeneca to present results of Farxiga’s DAPA-CKD trial at ESC 2020
By Mateen Dalal

According to reliable sources, British-Swedish multinational pharmaceutical company AstraZeneca plc will present the much awaited results of the Phase III DAPA-CKD trial of Farxiga in CKD (chronic kidney disease) at ESC Congress 2020. Sources with r...

FDA grants Emergency Use Authorization to Abbott’s COVID-19 antigen
FDA grants Emergency Use Authorization to Abbott’s COVID-19 antigen
By Mateen Dalal

Abbott Laboratories, a U.S.-based medical devices and healthcare firm, has reportedly received the Emergency Use Authorization (EUA) from the U.S. FDA (Food and Drug Administration) for the detecting COVID-19 virus with its portable antigen test Bina...

Hyundai Wia Corp. signs gun parts export contract with BAE Systems
Hyundai Wia Corp. signs gun parts export contract with BAE Systems
By Mateen Dalal

Hyundai Wia Corp., a South Korea-based defense firm, has reportedly signed gun parts export contract with BAE Systems plc of worth USD 100 million via a pre-value accumulation system. As per the agreement, Hyundai Wia will supply over 106 types of gu...