MRX-4 / Akari Therap - LARVOL DELTA

Population pharmacokinetics of the new oxazolidinone prodrug contezolid acefosamil (MRX-4) and its metabolites after single and multiple ascending intravenous doses in healthy volunteers (ECCMID 2019) - "Background: Efficacious treatment options against methicillin-resistant Staphylococcus aureus, penicillin-resistant Streptococcus pneumoniae, and vancomycin-resistant Enterococci with a promising safety profile are valuable...The multiple dose study included 600 or 900mg every 12h or 2100mg every 24h for 10 days; intensive PK samples were obtained on days 1 and 10... The overall extent of contezolid formation was largely independent of dose; only the rate of contezolid formation increased over time and was concentration-dependent. Clearance of contezolid was linear over a large dose range and had moderate between-subject variability in healthy volunteers. The proposed loading dose regimen was predicted to rapidly achieve effective concentrations."

Clinical • PK/PD data • Infectious Disease • Pneumonia • Respiratory Diseases

A Study for Efficacy and Safety of Live Biotherapeutic MRx4DP0004 to Treat COVID-19 (clinicaltrials.gov) - P2; N=90; Recruiting; Sponsor: 4D pharma plc; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Immune Modulation • Infectious Disease • Novel Coronavirus Disease

A study to test the effectiveness and safety of bacteria called Bifidobacterium breve in patients with COVID-19 infections (clinicaltrialsregister.eu) - P2; N=90; Ongoing; Sponsor: 4D pharma plc

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study for Efficacy and Safety of Live Biotherapeutic MRx4DP0004 to Treat COVID-19 (clinicaltrials.gov) - P2; N=90; Not yet recruiting; Sponsor: 4D pharma plc

Clinical • New P2 trial • Immune Modulation • Immunology • Infectious Disease • Novel Coronavirus Disease

A Study of MRx-4DP0004 in Asthma (clinicaltrials.gov) - P1/2; N=90; Recruiting; Sponsor: 4D pharma plc; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Study of MRx-4DP0004 (a Proprietary Strain of B. Breve) in Asthma (clinicaltrials.gov) - P1/2; N=90; Not yet recruiting; Sponsor: 4D pharma plc

Clinical • New P1/2 trial