Oxabact (lyophilised oxalobacter formigenes) / OxThera - LARVOL DELTA

ePHex: a phase 3, double-blind, placebo-controlled, randomized study to evaluate long-term efficacy and safety of Oxalobacter formigenes in patients with primary hyperoxaluria. (PubMed, Pediatr Nephrol) - "Oxabact treatment may have stabilized/reduced plasma oxalate versus a rise with placebo, but the difference over 12 months was not statistically significant (p = 0.06). A subtle effect observed with Oxabact suggests that O. formigenes may aid in preventing kidney stones. A higher resolution version of the Graphical abstract is available as Supplementary information."

Journal • P3 data • Genetic Disorders • Nephrology • Renal Calculi

EPHEX: A PHASE 3 DOUBLE-BLIND, PLACEBOCONTROLLED, RANDOMISED STUDY TO EVALUATE LONG-TERM EFFICACY AND SAFETY OF OXALOBACTER FORMIGENES IN PATIENTS WITH PRIMARY HYPEROXALURIA (ESPN 2021) - P3, N=NA; "The ePHex study represents the longest placebo-controlled phase 3 study with the objective to investigate efficacy and safety of Oxabact® in the treatment of patients with PH."

ePHex-OLE: An Extension Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria (clinicaltrials.gov) - P3; N=22; Terminated; Sponsor: OxThera; N=16 ➔ 22; Trial completion date: Apr 2023 ➔ Jul 2021; Active, not recruiting ➔ Terminated; Trial primary completion date: Apr 2023 ➔ Jul 2021; Parent, pivotal study (OC5-DB-02) did not meet primary endpoint. No safety concerns for early termination.

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Nephrology

A Study to Evaluate the Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria (clinicaltrials.gov) - P3; N=25; Completed; Sponsor: OxThera; Active, not recruiting ➔ Completed

Clinical • Trial completion • Nephrology

ePHex-OLE: An Extension Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria (clinicaltrials.gov) - P3; N=16; Active, not recruiting; Sponsor: OxThera; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Nephrology

"New OxThera/Oxabact US patent granted https://t.co/HjnLxAS50y" (@CisionNews)

Effects of Oxalobacter formigenes in subjects with primary hyperoxaluria Type 1 and end-stage renal disease: a Phase II study. (PubMed, Nephrol Dial Transplant) - "Compared with an untreated natural control cohort, 24 months OC5 administration was beneficial to PH1 ESRD subjects by substantially decreasing Pox concentrations, and improving or stabilizing cardiac function and clinical status, without increasing dialysis frequency. OC5 was safe and well-tolerated."

Clinical • Journal • P2 data • Chronic Kidney Disease • Metabolic Disorders • Nephrology • Renal Calculi • Renal Disease • Transplantation • Urolithiasis

ePHex-OLE: An Extension Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria (clinicaltrials.gov) - P3; N=16; Recruiting; Sponsor: OxThera; Trial completion date: Nov 2022 ➔ Apr 2023; Trial primary completion date: Nov 2022 ➔ Apr 2023

Clinical • Trial completion date • Trial primary completion date

Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Primary Hyperoxaluria Patients Who Are on Dialysis (clinicaltrials.gov) - P2; N=12; Completed; Sponsor: OxThera; Active, not recruiting ➔ Completed

Clinical • Trial completion

A Study to Evaluate the Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria (clinicaltrials.gov) - P3; N=25; Active, not recruiting; Sponsor: OxThera; Recruiting ➔ Active, not recruiting; Trial completion date: Nov 2020 ➔ Apr 2021; Trial primary completion date: Nov 2020 ➔ Apr 2021

Clinical • Enrollment closed • Trial completion date • Trial primary completion date

Oxalobacter formigenes treatment combined with intensive dialysis lowers plasma oxalate and halts disease progression in a patient with severe infantile oxalosis. (PubMed, Pediatr Nephrol) - "Treatment with O. formigenes combined with intensive dialysis led to reduction of Pox, stabilization of systemic oxalosis, and improvement in the clinical disease course. O. formigenes treatment may be an option for reduction of oxalosis in infantile patients with insufficient response to conservative treatments until combined liver-kidney transplantation can be performed."

Clinical • Journal