afabicin oral (Debio 1450) / Debiopharm - LARVOL DELTA

Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus (clinicaltrials.gov) - P2 | N=111 | Active, not recruiting | Sponsor: Debiopharm International SA | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease

Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus (clinicaltrials.gov) - P2 | N=111 | Recruiting | Sponsor: Debiopharm International SA | Trial completion date: Mar 2026 ➔ Dec 2026 | Trial primary completion date: Mar 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Infectious Disease

Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus (clinicaltrials.gov) - P2 | N=111 | Recruiting | Sponsor: Debiopharm International SA | Trial completion date: Apr 2025 ➔ Mar 2026 | Trial primary completion date: Apr 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Infectious Disease

Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus (clinicaltrials.gov) - P2 | N=96 | Recruiting | Sponsor: Debiopharm International SA | Trial completion date: Dec 2024 ➔ Apr 2025 | Trial primary completion date: Dec 2023 ➔ Apr 2025

Trial completion date • Trial primary completion date • Infectious Disease

Evaluation of the microbiota-sparing properties of the anti-staphylococcal antibiotic afabicin. (PubMed, J Antimicrob Chemother) - "Oral treatment with afabicin is associated with preservation of the gut microbiota in mice and healthy subjects."

Journal • Infectious Disease

Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus (clinicaltrials.gov) - P2 | N=96 | Recruiting | Sponsor: Debiopharm International SA | Trial completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Infectious Disease

Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus (clinicaltrials.gov) - P2 | N=96 | Recruiting | Sponsor: Debiopharm International SA | Trial completion date: Oct 2022 ➔ Dec 2023 | Trial primary completion date: Oct 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • Infectious Disease

Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus (clinicaltrials.gov) - P2; N=96; Recruiting; Sponsor: Debiopharm International SA; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open

Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus (clinicaltrials.gov) - P2; N=96; Active, not recruiting; Sponsor: Debiopharm International SA; Trial completion date: Dec 2021 ➔ Oct 2022; Trial primary completion date: Jul 2021 ➔ Oct 2022; N=60 ➔ 96

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

Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus (clinicaltrials.gov) - P2; N=60; Active, not recruiting; Sponsor: Debiopharm International SA; N=96 ➔ 60; Trial completion date: Jul 2020 ➔ Dec 2021; Trial primary completion date: Jul 2020 ➔ Jul 2021

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

Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus (clinicaltrials.gov) - P2; N=96; Active, not recruiting; Sponsor: Debiopharm International SA; N=60 ➔ 96

Clinical • Enrollment change

Afabicin, a first-in-class anti-staphylococcal antibiotic, in the treatment of acute bacterial skin and skin structure infections: clinical non-inferiority to vancomycin/linezolid. (PubMed, Antimicrob Agents Chemother) - "Randomized patients (1:1:1) received either: low dose (LD) afabicin (IV 80 mg, then oral 120 mg, BID); high dose (HD) afabicin (IV 160 mg, then oral 240 mg, BID); or vancomycin/linezolid (IV vancomycin 1 g or 15 mg/kg, then oral linezolid 600 mg, BID). Both LD and HD afabicin were non-inferior to vancomycin/linezolid (differences: -3.5%, 95% CI [-10.8%, 3.9%] and 1.0%, 95% CI [-7.3%, 9.2%], respectively). Most common treatment-emergent adverse events were mild, and were headache (9.1% and 16.8%) and nausea (6.4% and 8.4%) with LD and HD afabicin, respectively.Afabicin was efficacious and well-tolerated in the treatment of ABSSSI due to staphylococci, and these data support further development of afabicin for the treatment of ABSSSI and potentially other types of staphylococcal infections."

Clinical • Head-to-Head • Journal

Activity of Debio 1452 against Staphylococcus spp. collected in 2015/2016 (ECCMID 2018) - "Consistent with historical data, Debio 1452 exhibited excellent in vitro activity against all staphylococci tested in the study. The activity of Debio 1452 was superior to other agents with no cross-resistance. Further studies are warranted in support of clinical development of afabicin for the treatment of staphylococcal infection."

Biosimilar • Immunology

Bone and Joint Tissues Penetration of the Staphylococcus-Selective Antibiotic Afabicin in Patients Undergoing Elective Hip Replacement Surgery. (PubMed, Antimicrob Agents Chemother) - P1; "Afabicin desphosphono concentrations were measured by LC-MS/MS in plasma, cortical bone, cancellous bone, bone marrow, soft tissue and synovial fluid collected during surgery at 2, 4, 6, or 12 hours after the third afabicin dose.The study showed good penetration of afabicin desphosphono into bone tissues with mean AUC ratios for cortical, cancellous, bone marrow, soft tissue and synovial fluid to total plasma concentrations of 0.21, 0.40, 0.32, 0.35 and 0.61, respectively. When accounting for the free fraction in plasma (2%) and synovial fluid (9.4%), the mean ratio was 2.88 which is indicative of excellent penetration, and showed that afabicin desphosphono concentration was beyond MIC90 of S. aureus over the complete dosing interval.These findings, along with preclinical efficacy data, clinical efficacy data in skin and soft tissue staphylococcal infection, availability of both IV and oral formulations, and potential advantages over broad-spectrum antibiotics for the..."

Clinical • Journal

Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus (clinicaltrials.gov) - P2; N=60; Active, not recruiting; Sponsor: Debiopharm International SA; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Debiopharm International SA; Trial completion date: Nov 2019 ➔ Jul 2020; Trial primary completion date: Nov 2019 ➔ Jul 2020

Clinical • Trial completion date • Trial primary completion date

Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Debiopharm International SA; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open