Expert Interview
Exploring the potential of Regulus Therapeutics’ RNA-Targeted Drug RGLS8429 in autosomal dominant polycystic kidney disease (ADPKD)
Ticker(s): RGLS, NVSInstitution: Baylor/Texas A&M
- Clinical Assistant Professor of Medicine at Texas A&M University, Staff Physician at the Baylor Regional Transplant Institute, and partner at Dallas Nephrology Associates
- Manages 75 patients a week with kidney disease with a focus on chronic kidney disease, end stage renal disease, transplantation, and dialysis.
- Active in clinical research and is published in international journals in both nephrology and transplantation.
How does RGLS8429 differentiate itself mechanistically and clinically from other emerging therapies in the ADPKD pipeline?
Added By: dami_adminWhat key findings from the Phase 1b trial do you believe are most impactful for future regulatory milestones or partnership discussions?
Added By: dami_adminGiven the chronic nature of ADPKD, how does RGLS8429’s safety and dosing profile support its long-term use compared to current standards of care?
Added By: dami_adminwhat do you think the chance of having at least a 50% slowing of growth of the kidney versus placebo might be for the phase 3 trial. This seems to be the 12 month endpoint for accelerated approval (am i right?). I am not sure we know the mix of 1C, 1D, 1E patients, all of whose kidneys grow at different annual rates. I wonder if it is easier to slow kidney volume in the different categories of patients. Teldapvan i believed showed a 50% slowing of kidney volume, but I don't know the mix of patients they had.
Added By: user1a9v3vo5If you were novartis, and you had an $800m milestone to pay on first approval, would you redesign the phase 3 so as NOT to get accelerate approval at 12 months off slower progression of kidney volume, but instead just have one ph3 endpoint at 24 months that measures egfr vs placebo? What do you think the chances are for RGLS to hit on this final endpoint for full approval?
Added By: user1a9v3vo5Are You Interested In These Questions?
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