Another Eylea rival struggles in phase 2, this time fielded by Ribomic -biotech.vision

Another Eylea rival struggles in phase 2, this time fielded by Ribomic

Another attempt to fight Regeneron and Bayer giant Eylea is struggling in the clinic. This time RBM-007 is the therapy of robotic age-related macular degeneration (AMD).

Small biotechnology showed a “positive trend” for individual therapy in the early results of the phase 2 clinical trial called TEMPURA. Updated secondary endpoint results from two previous medium-term studies called TOFU and RAMEN showed that RBM-007 alone and in combination with Eylea failed.

Since TEMPURA, RBM-007 has induced a “positive trend” in biomarkers associated with improved ocular anatomy and correct vision. The therapy was injected once monthly for three months in treatment-naïve patients with wet AMD, a chronic eye disease caused by blurred vision or blind spots.

TEMPURA’s primary goal was to improve the macular thickness of imaging, according to the FDA’s Clinical Trials Database. Ribomic did not report data on this primary endpoint.

According to Ribomic, the biomarker data from the TEMPURA study could indicate that RBM-007 still has potential in patients who have not yet received treatment for eye disease. Most of the patients in the study treated with the candidate saw improvement in anatomy and vision, and one showed “significant improvement”. This person received 12 letters on a standard vision test, and vision continued to improve after stopping the dose. By the end of the study period, the patient had received 15 letters, Ribomic said.

Only one patient in the Eylea study required emergency treatment, but no improvement in vision was observed after this procedure. The study was sponsored by an investigator-led by Dr. Raj Maturi of the Midwest Eye Institute.

Ribomic also reported secondary results from TOFU and RAMEN studies, which included previously treated wet AMD patients who had received RBM-007 alone or in combination with Eylea. In TOFU, therapy did not show any improvement over Eylea in any anatomical parameters, including a decrease in retinal thickness.

No benefit was seen in RAMEN, an open-label extension study in which dosing was extended to patients with TOFU experience.

However, Ribomic said that all three studies combined showed that RBM-007 appears to be “effective” in improving vision and retinal anatomy in treated naval patients compared to eyes previously treated with anti-aging agents. to which Eylea belongs. to the.

Eylea, which posted global net sales of $ 9.4 billion in 2021, is also approved for diabetic macular edema (DME) and macular edema after retinal vein occlusion.

Ribomic is not the first biotechnologist to attempt to adopt Regeneron and Bayer’s flagship drug. Kodiak Sciences last month reported a flop for the first study in a series of six phases 3 trials of KSI-301, which implemented the entire program.

Roche, on the other hand, was more successful, gaining FDA approval for Vabysmo in DME and wet AMD in January.

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