ORAvance (BRII-672) / Brii Biosci, Shionogi - LARVOL DELTA

P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants (clinicaltrials.gov) - P1 | N=71 | Recruiting | Sponsor: Qpex Biopharma, Inc. | Trial primary completion date: Aug 2025 ➔ Dec 2025

Trial primary completion date • Infectious Disease

PK & Safety Study of Xeruborbactam Oral Prodrug Combined With Ceftibuten in Participants With Renal Impairment (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Qpex Biopharma, Inc. | Recruiting ➔ Completed

Trial completion • Infectious Disease • Renal Disease

PK & Safety Study of Xeruborbactam Oral Prodrug Combined With Ceftibuten in Participants With Renal Impairment (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Qpex Biopharma, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Renal Disease

P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants (clinicaltrials.gov) - P1 | N=71 | Recruiting | Sponsor: Qpex Biopharma, Inc. | Trial completion date: Dec 2024 ➔ Oct 2025 | Trial primary completion date: Sep 2024 ➔ Aug 2025

Trial completion date • Trial primary completion date • Infectious Disease

PK & Safety Study of Xeruborbactam Oral Prodrug Combined With Ceftibuten in Participants With Renal Impairment (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Qpex Biopharma, Inc. | Initiation date: Jun 2024 ➔ Oct 2024

Trial initiation date • Infectious Disease • Renal Disease

P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Qpex Biopharma, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease

P1, Open-label, SAD PK & Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Renal Impairment Pts (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Qpex Biopharma, Inc.

New P1 trial • Infectious Disease • Renal Disease

P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Qpex Biopharma, Inc. | N=48 ➔ 72

Combination therapy • Enrollment change • Infectious Disease

P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Qpex Biopharma, Inc.

Combination therapy • New P1 trial • Infectious Disease

Phase 1 Oral QPX7831 SAD and MAD in Healthy Adults (clinicaltrials.gov) - P1 | N=75 | Completed | Sponsor: Qpex Biopharma, Inc. | Recruiting ➔ Completed

Trial completion • Infectious Disease

Phase 1 Oral QPX7831 SAD and MAD in Healthy Adults (clinicaltrials.gov) - P1 | N=78 | Recruiting | Sponsor: Qpex Biopharma, Inc. | Trial completion date: Apr 2022 ➔ Aug 2022 | Trial primary completion date: Dec 2021 ➔ Jun 2022

Trial completion date • Trial primary completion date • Infectious Disease

Selection of QPX7831, an Orally Bioavailable Prodrug of Boronic Acid β-Lactamase Inhibitor QPX7728. (PubMed, J Med Chem) - "Seventeen prodrugs were synthesized; key properties investigated were rates of cleavage to the active form in vitro, pharmacokinetics across species, and crystallinity. Compound 5-Na (QPX7831 Sodium) emerged with optimal properties across all key attributes."

Journal • Infectious Disease

Phase 1 Oral QPX7831 SAD and MAD in Healthy Adults (clinicaltrials.gov) - P1; N=80; Recruiting; Sponsor: Qpex Biopharma, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease

Phase 1 Oral QPX7831 SAD and MAD in Healthy Adults (clinicaltrials.gov) - P1; N=80; Not yet recruiting; Sponsor: Qpex Biopharma, Inc.; N=136 ➔ 80

Clinical • Enrollment change • Infectious Disease