SUSHI study achieved the primary endpoint of safety and tolerability, and also demonstrated efficacy trends in favor of RBM-007.
Subjects recruited for the SUSHI Study had wet AMD that was poorly responsive to previous intravitreal anti-VEGF therapy. Through the 56-Day exit visit, excluding one uncompleted case in the last cohort, single dose of RBM-007 demonstrated no dose-limiting toxicities, no systemic or ocular serious adverse events. One subject in Cohort 3 showed anterior inflammation, which was resolved after one day of topical prednisolone treatment. Rescue treatment with anti-VEGF therapy was available for those subjects who met criteria.
Secondary outcomes at the primary study endpoint of 28 days showed evidence of bioactivity of RBM-007. Seven out of nine subjects responded to RBM-007, in terms of any vision gain in Best- Corrected Visual Acuity (BCVA) or ≥50 µm improvement in Central Retinal Thickness on optical coherence tomography (OCT) as reported in case report forms. Vision improved at Day 28 in 2 subjects in Cohort 1, 2 subjects in Cohort 2 and 1 subject in Cohort 3. OCT improvement ≥50 µm at Day 28 was noted in 1 subject in Cohort 2 and all Cohort 3 subjects.
Overall, a single intravitreal injection of RBM-007 in the study eye was well-tolerated and indicated bioactivity in a majority of these wet AMD subjects, who had been poorly responsive to prior anti-VEGF therapy.
Additional data analyses of SUSHI study are on-going and will be presented at future medical meetings. Planning for the next multi-dose Phase 2 clinical trial is underway and enrollment is expected to begin in 3Q of FY2019.
“We are very encouraged by the results of SUSHI study. This was designed as a first-in-human, single-dose safety study and has exceeded our expectations from the standpoint of bioactivity. We will promote the clinical development of RBM-007 to provide wet AMD patients with this new solution as quickly as possible.” said Yoshikazu Nakamura, Ph.D., CEO and president of RIBOMIC Inc.
“SUSHI study has demonstrated that single dose of intravitreal RBM-007 up to 2 mg dose is well-tolerated in subjects with wet AMD. We are pleased to demonstrate evidence of clinical efficacy in several subjects as measured by BCVA and OCT thickness suggesting FGF2 is an important target in the pathogenesis of wet AMD” said Yusuf Ali, Ph.D., CEO of RIBOMIC USA Inc.
“The SUSHI study results demonstrate the ocular safety of intravitreal RBM-007, and the improvements seen in eyes with chronic exudation hold promise for a new therapeutic target in wet AMD” said Robert Bhisitkul, MD. Ph.D., Professor at University of California San Francisco, and an executive scientific advisor of RIBOMIC Inc.
Source: Company Press Release