meplazumab / Jiangsu Pacific Meinuoke Biopharmaceutical, Air Force Medical University - LARVOL DELTA

Inducible CD147 up-regulation boosts extended SARS-CoV-2 infection triggering severe COVID-19 independent of ACE2. (PubMed, Signal Transduct Target Ther) - "Importantly, we further present the cryo-EM structure of CD147-spike complex, and identify five pairs of functional residues for their interaction, which could be interrupted by Meplazumab via steric hindrance effect. Our findings provide direct evidence for CD147-SARS-CoV-2 spike interaction and uncover the pathogenesis of severe COVID-19 caused by CD147-mediated extended virus infection."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • BSG

REC-SAFECAD: Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease (clinicaltrials.gov) - P2 | N=18 | Recruiting | Sponsor: Xijing Hospital | Trial completion date: Mar 2026 ➔ Mar 2027 | Trial primary completion date: Sep 2025 ➔ Sep 2026

Trial completion date • Trial primary completion date • Cardiovascular • Coronary Artery Disease

Meplazumab, a CD147 antibody, for severe COVID-19: a double-blind, randomized, placebo-controlled, phase 3 clinical trial. (PubMed, Signal Transduct Target Ther) - P3 | "Meplazumab demonstrated good safety and tolerability, with no grade ≥ 3 TEAEs observed. These promising results indicate that meplazumab reduces mortality and enhances clinical benefits in severe COVID-19 patients with a good safety profile, providing effective and specific therapeutics for severe COVID-19 (the trial was registered at ClinicalTrials.gov (NCT05679479))."

Clinical • Journal • P3 data • Infectious Disease • Novel Coronavirus Disease • BSG

Open-Label Study to Assess Meplazumab in Adult Patients Diagnosed with Plasmodium Falciparum (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Oct 2025 | Trial primary completion date: Sep 2024 ➔ Aug 2025

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Malaria

REC-SAFECAD: Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease (clinicaltrials.gov) - P2 | N=18 | Recruiting | Sponsor: Xijing Hospital

New P2 trial • Cardiovascular • Coronary Artery Disease

Study on the Safety and Efficacy of Meplazumab for Injection in Severe Patients With COVID-19 (clinicaltrials.gov) - P3 | N=108 | Completed | Sponsor: Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd | Suspended ➔ Completed | Trial primary completion date: Apr 2024 ➔ Jan 2024

Trial completion • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Open-Label Study to Assess Meplazumab in Adult Patients Diagnosed With Plasmodium Falciparum (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd | Not yet recruiting ➔ Recruiting | Trial completion date: Sep 2024 ➔ Dec 2024

Enrollment open • Trial completion date • Infectious Disease • Malaria

Comparative assessment of different anti-CD147/Basigin 2 antibodies as a potential therapeutic anticancer target by molecular modeling and dynamic simulation. (PubMed, Mol Divers) - "Next, from HADDOCK 2.4., we meticulously handpicked the most superior model clusters (Z-Score: - 2.5 to - 1.2) and identified that meplazumab had higher affinities according to the success rate as the percentage of a scoring scale. We achieved stable simulations of CD147-antibody interaction. Our outcomes hold hypothetical importance for further experimental cancer research on the design and development of the relevant model antibodies."

Journal • Oncology • Solid Tumor • CD14

Open-Label Study to Assess Meplazumab in Adult Patients Diagnosed With Plasmodium Falciparum (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd | Phase classification: P2a ➔ P2

Phase classification • Infectious Disease • Malaria

To Evaluate the Safety and Efficacy of Meplazumab in Treatment of Post-COVID-19 (clinicaltrials.gov) - P3 | N=121 | Completed | Sponsor: Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

Study on the Safety and Efficacy of Meplazumab for Injection in Severe Patients With COVID-19 (clinicaltrials.gov) - P3 | N=108 | Suspended | Sponsor: Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd | N=350 ➔ 108 | Trial completion date: Dec 2023 ➔ May 2024 | Recruiting ➔ Suspended | Trial primary completion date: Nov 2023 ➔ Apr 2024

Enrollment change • Trial completion date • Trial primary completion date • Trial suspension • Infectious Disease • Novel Coronavirus Disease

Study on the Safety and Efficacy of Meplazumab for Injection Patients COVID-19 (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd | N=1320 ➔ 0 | Suspended ➔ Withdrawn

Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease

Clinical Study of Meplazumab to Treat With Malaria (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd | N=112 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Infectious Disease • Malaria

Open-Label Study to Assess Meplazumab in Adult Patients Diagnosed With Plasmodium Falciparum (clinicaltrials.gov) - P2a | N=60 | Not yet recruiting | Sponsor: Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd

New P2a trial • Infectious Disease • Malaria

the Safety and Efficacy of Meplazumab in Patients With COVID-19 (clinicaltrials.gov) - P2/3 | N=150 | Completed | Sponsor: Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd | Recruiting ➔ Completed | Trial completion date: Sep 2023 ➔ Oct 2022 | Trial primary completion date: Aug 2023 ➔ Sep 2022

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Study on the Safety and Efficacy of Meplazumab for Injection in Severe Patients With COVID-19 (clinicaltrials.gov) - P3 | N=350 | Recruiting | Sponsor: Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd | Trial primary completion date: Jun 2023 ➔ Nov 2023

Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Study to Assess the Effect of Meplazumab on COVID-19 (clinicaltrials.gov) - P2/3 | N=174 | Completed | Sponsor: Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd | Recruiting ➔ Completed | N=456 ➔ 174 | Trial completion date: Sep 2023 ➔ Dec 2022 | Trial primary completion date: Jun 2023 ➔ Dec 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

To Evaluate the Safety and Efficacy of Meplazumab in Treatment of Post-COVID-19 (clinicaltrials.gov) - P3 | N=144 | Recruiting | Sponsor: Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd | Trial primary completion date: Jun 2023 ➔ Sep 2023

Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

To Evaluate the Safety and Efficacy of Meplazumab in Treatment of COVID-19 Sequelae (clinicaltrials.gov) - P3 | N=144 | Recruiting | Sponsor: Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd

New P3 trial • Infectious Disease • Novel Coronavirus Disease

Study on the Safety and Efficacy of Meplazumab for Injection Patients COVID-19 (clinicaltrials.gov) - P3 | N=1320 | Suspended | Sponsor: Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd | Initiation date: Jan 2023 ➔ May 2023 | Not yet recruiting ➔ Suspended | Trial primary completion date: Jun 2023 ➔ Sep 2023

Trial initiation date • Trial primary completion date • Trial suspension • Infectious Disease • Novel Coronavirus Disease

Study on the Safety and Efficacy of Meplazumab for Injection in Severe Patients With COVID-19 (clinicaltrials.gov) - P3 | N=350 | Recruiting | Sponsor: Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease

Meplazumab in hospitalized adults with severe COVID-19 (DEFLECT): a multicenter, seamless phase 2/3, randomized, third-party double-blind clinical trial. (PubMed, Signal Transduct Target Ther) - P2/3 | "In this study, the adverse events occurred at a comparable rate across the four groups, with no unexpected safety findings observed. In conclusion, meplazumab promoted COVID-19 convalescence and reduced mortality, viral load, and cytokine levels in severe COVID-19 population with good safety profile."

Journal • P2/3 data • Infectious Disease • Novel Coronavirus Disease • BSG • CXCL8 • IL4

Safety, Biodistribution, and Dosimetry Study of Meplazumab, a Potential COVID-19 Therapeutic Drug, with I-Labeling and SPECT Imaging. (PubMed, Mol Pharm) - "It was safe and feasible to perform human clinical imaging experiments using a diagnostic dose of I-meplazumab after thyroid closure by Lugol's solution. This study will provide more experimental basis for advancing the clinical translation of meplazumab and will be valuable in evaluating therapeutic interventions for patients with COVID-19, as well as providing a reference for clinical translation studies of other antibody drugs."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • BSG

Study on the Safety and Efficacy of Meplazumab for Injection in Adults With Mild and Moderate COVID-19 Infections (clinicaltrials.gov) - P3 | N=1320 | Not yet recruiting | Sponsor: Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd

New P3 trial • Infectious Disease • Novel Coronavirus Disease • CD4 • CD8 • CRP

Study on the Safety and Efficacy of Meplazumab for Injection in Severe Patients With COVID-19 (clinicaltrials.gov) - P3 | N=350 | Not yet recruiting | Sponsor: Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd

New P3 trial • Infectious Disease • Novel Coronavirus Disease