Oxabact (Oxalobacter formigenes)for the treatment of recurrent Primary Hyperoxaluria in kidney transplant recipients

Overall, the project plan is currently composed of about 5 main Work Packages, but this may be detailed further throughout the project application phase: 1.CONSORTIUM MANAGEMENT AND ADMINISTRATION 2.REGULATORY AFFAIRS a.Regulatory strategy plan for marketing authorisations in the EU and US b.EMA-COMP consultation (protocol assistance meetings) c.FDA consultation meetings d.Risk management planning (pre-study safety considerations for exposure of Oxabact to immunosuppressed patients) 3.CLINICAL TRIAL(s) a.Patient recruitment strategy plan (prevalence study) b.Transplant centres network and infrastructure c.Proof-of-concept study A: Continued treatment in PH: from dialysis to post-rTX d.Proof-of-concept study B: Prevention of PH in rTX patients e.Proof-of-concept study C: Treatment of recurrent PH after rTX 4.BIOMARKERS AND SURROGATE ENDPOINTS a.Immunology markers/immune staining b.Molecular profiling c.miRNA profiling in urine 5.EXPLOITATION AND DISSEMINATION a.Publication and dissemination b.Business development