Drugs / Oxalobacter formigenes OC5
Oxalobacter formigenes OC5
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT02012985 | Dec 2013 → Jan 2015 | primary hyperoxaluria | OxThera | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2021-06-11 | OxThera | Results OxThera reports results from Phase 3 ePHex study with Oxabact in primary hyperoxaluria patients with maintained kidney function cision.com ↗
OxThera AB, a privately-held biopharmaceutical company dedicated to improving the lives of people with Primary Hyperoxaluria (PH), announces completion of its pivotal Phase 3 study and reports top line results. |
| 2020-06-29 | OxThera | Regulatory OxThera Receives Rare Pediatric Disease Designation from U.S. FDA for Oxabact Treatment of Primary Hyperoxaluria cision.com ↗
OxThera AB, a privately-held biopharmaceutical company dedicated to improving the lives of people with Primary Hyperoxaluria (PH), today announced that the U.S. Food and Drug Administration (“FDA”) has granted a Rare Pediatric Disease Designation for Oxabact OC5. |
| 2020-03-12 | OxThera | Results Oxabact[®] treatment combined with intensive dialysis lowers plasma oxalate and halts disease progression in a patient with severe infantile oxalosis cision.com ↗
The treatment reduced plasma oxalate levels and stabilized systemic oxalosis. |
| 2019-11-07 | OxThera | Results OxThera presents full 24-month data for Oxabact ® in Primary Hyperoxaluria type 1 (PH1) patients with ESRD at Kidney Week 2019 cision.com ↗
The results show that two years of treatment with Oxabact reduced mean plasma oxalate (Pox) by approximately 40% in PH1 patients with ESRD, without intensification in their dialysis regimen. |
| 2019-06-27 | OxThera | Results OxThera presents continuous strong data from an interim analysis of its Phase 2 study with Oxabact in Primary Hyperoxaluria cision.com ↗
The two-year interim analysis shows continuous reductions in Pox (level of oxalate in the blood plasma) of - 40% (-67 µmol/L) compared with baseline. |
| 2018-10-31 | OxThera | Results OxThera presents encouraging 52-week efficacy and safety data for Oxabact® in Primary Hyperoxaluria type 1 (PH1) patients with ESRD cision.com ↗
OxThera AB, a Stockholm-based privately-held biopharmaceutical company and leader in the field of microbiome derived biotherapeutics, today announced a poster presentation showing encouraging Oxabact® efficacy and safety data from the longterm study OC5-OL-01, at the Annual Meeting of the American Society of Nephrology Kidney Week 2018 in San Diego. |
All press releases naming this drug 13 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Oxalobacter formigenes OC5 | “The active study drug consists of Oxalobacter formigenes OC5 in enteric-coated size-4 capsules.” NCT02012985 ↗ |
| Known as | OC5 | “Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Patients With Primary Hyperoxaluria” NCT02012985 ↗ |
| Known as | Oxabact | “Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Patients With Primary Hyperoxaluria” NCT02012985 ↗ |
| Route | Oral | “The dose (an enteric-coated size 4 capsule) will be administered orally with breakfast and dinner.” NCT02012985 ↗ |