afabicin IV (Debio 1450 IV) / 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

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

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