Ribomic has announced positive top-line results from its Phase I/IIa single ascending dose SUSHI study of RBM-007 in patients with wet Age-Related Macular Degeneration (wet AMD).
The open-label, dose escalation SUSHI study achieved the primary endpoint of safety and tolerability, and also demonstrated efficacy trends in favour of the anti-FGF2 aptamer.
Nine subjects who had received ≥3 anti-VEGF treatments earlier without resolution of wet AMD participated in the study.
They received a single intravitreal injection of RBM-007 in three sequential dose cohorts.
Ribomic recruited patients who had wet AMD that was poorly responsive to previous intravitreal anti-VEGF therapy.
Secondary outcomes at the primary study endpoint of 28 days showed evidence of bioactivity of RBM-007.
A single intravitreal injection of RBM-007 in the study eye was well-tolerated and indicated bioactivity in a majority of subjects with wet AMD.
The company is planning for the next multi-dose Phase II clinical trial, which is underway, with enrolment expected to start in the third quarter of 2019.
Ribomic CEO and president Yoshikazu Nakamura said: “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.”
Wet AMD is caused by the formation of abnormal and leaky new blood vessels under the retina and is the leading cause of blindness in the US and Europe.