Another attempt to take on Regeneron and Bayer’s juggernaut Eylea is struggling in the clinic. This time, it’s Ribomic’s wet age-related macular degeneration (AMD) therapy RBM-007.
The small biotech revealed a “positive trend” for the solo therapy in initial results from a phase 2 clinical trial called TEMPURA. Updated results on the secondary endpoints from two earlier midstage trials, called TOFU and RAMEN, showed RBM-007 was unsuccessful alone and as an add-on to Eylea.
Starting with TEMPURA, RBM-007 spurred a “positive trend” in biomarkers related to improvement of eye anatomy and corrected vision. The therapy was injected once a month for three months in treatment-naïve patients with wet AMD, a chronic eye condition that causes blurred vision or blind spots.
TEMPURA’s main goal was to improve macular thickness as assessed using imaging, according to the FDA’s clinical trials database. Ribomic did not report data on this main outcome.
But Ribomic does say the TEMPURA’s trial’s biomarker data could signal that RBM-007 still has potential in patients who have not previously received treatment for the eye disease. A majority of the trial patients treated with the candidate saw improvement in anatomy and vision, with one showing “strong improvement.” That person gained 12 letters on a standard vision test, and vision continued to improve after dosing ended. At the end of the study period, the patient had a gain of 15 letters, Ribomic said.
Only one patient in the trial required rescue treatment with Eylea, but no improvement in vision was shown after that intervention. The investigator-sponsored study was conducted by Raj Maturi, M.D., of the Midwest Eye Institute.
Ribomic also reported secondary outcomes from the TOFU and RAMEN studies, which featured previously treated wet AMD patients who received either RBM-007 alone or as an add-on to Eylea. In TOFU, the therapy did not demonstrate an improvement over Eylea for any of the anatomical endpoints, which included reduction of retinal thickness.
No benefit turned up in RAMEN, an open-label extension study where dosing was extended to pretreated patients from TOFU.
Nevertheless, Ribomic claimed the three studies combined showed RBM-007 “appears effective” in improving vision and retinal anatomy in treatment-naïve patients when compared to eyes that had previously been treated with long-term anti-VEGF agents, the class that Eylea belongs to.
Eylea, which clocked $9.4 billion in worldwide net sales in 2021, is also approved in diabetic macular edema (DME) and macular edema following retinal vein occlusion.
Ribomic is not the first biotech to try to take on Regeneron and Bayer’s blockbuster drug. Kodiak Sciences reported a flop last month for the first trial in a series of six phase 3 studies of KSI-301, casting a cloud over the entire program.
Roche, meanwhile, has had more success, having gained an FDA nod for Vabysmo in both DME and wet AMD in January.