“As an investigator of THR-149, I was encouraged to see the results from its clinical phase 1 trial. The molecule was found to be safe, very safe even, and we got a biological signal that it worked”, says Pravin Dugel, M.D.
The improvement in vision was measured only by BCVA, not in OCT. Why is that?
Pravin Dugel, M.D.: “That’s a question we get a lot. OCT, or optical coherence tomography, measures permeability, the amount of fluids the retina lets through. As of now it is the main biomarker to assess efficacy of DME treatment. For anti-VEGF drugs this is perfect. Anti-VEGF drugs stop permeability, so this marker can measure how well they work.
“VEGF-independent medicine possibly has a different method of action, for which there is no good biomarker at the moment. The next best thing is measuring vision improvement in patients. And even in this small trial of only 12 patients, after 1 injection we found quick and maintained vision improvement from day 1 to day 90. This improvement was bigger than could be expected through normal variability, so that is very promising.”
As an investigator of THR-149, I was encouraged to see the results from its clinical phase 1 trial. The molecule was found to be safe, very safe even, and we got a biological signal that it worked.
-Pravin Dugel, M.D.
Why do we need a VEGF-independent pathway?
“Because a significant part of DME patients cannot be treated successfully at the moment. We know that DME progresses from being driven by permeability to being driven by inflammation. Anti-VEGF drugs work for patients in the permeability phase but not for those in the inflammation phase. The problem is that we can’t tell which phase a patient is in because we have no biomarkers to test this. Because of this, all patients with DME get anti-VEGF injections in the eye but about 40 percent respond poorly or not at all. A different approach is necessary to address these patients’ need. For them a VEGF-independent pathway might be the solution.”
What is the future of THR-149?
“THR-149 holds the potential to be the different method of action that poor- or non-responders to anti-VEGF treatment are waiting for. But first, a clinical phase 2 study will have to be designed to assess efficacy. Overall, the phase 1 study’s data clearly warrant further clinical research with multiple injections of THR-149.”
> Click here to read more about the potential of THR-149 to treat DME
Pravin Dugel, M.D. is a clinical professor of ophthalmology and retinal specialist and works with Oxurion as an investigator and consultant.May 5th, 2020