QPX2014 / Shionogi - LARVOL DELTA

Antibiotics and non-traditional antimicrobial agents for pseudomonas aeruginosa in clinical phases 1, 2, and 3 trials. (PubMed, Expert Opin Investig Drugs) - "Traditional agents in clinical development include β-lactam/β-lactamase inhibitors (funobactam, taniborbactam, QPX2014-xeruborbactam), aminoglycosides (apramycin), polymyxin derivatives (upleganan, MRX-8, and SPR741), fluoroquinolones (MP-376), and lipopolysaccharide transport inhibitors (murepavadin). Non-traditional antibiotics in clinical development include anti-virulence agents (fluorothiazinone), monoclonal antibodies (INFEX-702, TRL-1068, and CMTX-101), bacteriophages (AP-PA02, YPT-01, BX004-A, and WRAIR-PAM-CF1), and miscellaneous agents (AR-501, PLG-0206, SNSP-113, OligoG CF-5/20, and ALX-009). A considerable number of antimicrobial agents, some with novel mechanisms of action, are in clinical phases of development for treating Pseudomonas aeruginosa infections. The urgent need for more therapeutic options necessitates the rapid optimization of progress to introduce new agents into clinical practice."

Journal • Review • Infectious Disease

P1 Single and Multiple Ascending Dose (SAD/MAD) Study of IV QPX7728 Alone and Combined With QPX2014 in NHV (clinicaltrials.gov) - P1 | N=82 | Completed | Sponsor: Qpex Biopharma, Inc. | Recruiting ➔ Completed

Combination therapy • Trial completion • Infectious Disease

P1 Single and Multiple Ascending Dose (SAD/MAD) Study of IV QPX7728 Alone and Combined With QPX2014 in NHV (clinicaltrials.gov) - P1 | N=86 | Recruiting | Sponsor: Qpex Biopharma, Inc. | Completed ➔ Recruiting | Trial completion date: Mar 2022 ➔ Sep 2022 | Trial primary completion date: Feb 2022 ➔ Aug 2022

Combination therapy • Enrollment open • Trial completion date • Trial primary completion date • Infectious Disease

P1 Single and Multiple Ascending Dose (SAD/MAD) Study of IV QPX7728 Alone and Combined With QPX2014 in NHV (clinicaltrials.gov) - P1 | N=71 | Completed | Sponsor: Qpex Biopharma, Inc. | Recruiting ➔ Completed

Combination therapy • Trial completion • Infectious Disease

P1 Single and Multiple Ascending Dose (SAD/MAD) Study of IV QPX7728 Alone and Combined With QPX2014 in NHV (clinicaltrials.gov) - P1 | N=71 | Recruiting | Sponsor: Qpex Biopharma, Inc. | Trial completion date: Aug 2021 ➔ Jun 2022 | Trial primary completion date: Aug 2021 ➔ Mar 2022

Combination therapy • Trial completion date • Trial primary completion date • Infectious Disease

Drug-Drug Interaction Study of IV QPX2014 Combined With QPX7728 in Healthy Adult Subjects (clinicaltrials.gov) - P1; N=12; Completed; Sponsor: Qpex Biopharma, Inc.; Recruiting ➔ Completed; Trial completion date: Feb 2022 ➔ Nov 2021

Clinical • Trial completion • Trial completion date • Infectious Disease

Drug-Drug Interaction Study of IV QPX2014 Combined With QPX7728 in Healthy Adult Subjects (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Qpex Biopharma, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease

P1, Single Dose Drug-Drug Interaction Study of IV QPX2014 Alone and Combined With QPX7728 in Healthy Adult Subjects (clinicaltrials.gov) - P1; N=12; Not yet recruiting; Sponsor: Qpex Biopharma, Inc.

Clinical • New P1 trial • Infectious Disease

P1 Single and Multiple Ascending Dose (SAD/MAD) Study of IV QPX7728 Alone and Combined With QPX2014 in NHV (clinicaltrials.gov) - P1; N=88; Recruiting; Sponsor: Qpex Biopharma, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Infectious Disease

P1 Single and Multiple Ascending Dose (SAD/MAD) Study of IV QPX7728 Alone and Combined With QPX2014 in NHV (clinicaltrials.gov) - P1; N=88; Not yet recruiting; Sponsor: Qpex Biopharma, Inc.; Trial completion date: May 2021 ➔ Aug 2021; Trial primary completion date: May 2021 ➔ Aug 2021

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Infectious Disease