SCTA01 / Sinocelltech - LARVOL DELTA

Efficacy and safety of SARS-CoV-2 neutralizing antibody, SCTA01, in high-risk outpatients diagnosed with COVID-19: A Phase II clinical trial. (PubMed, Contemp Clin Trials Commun) - P2/3 | "There was no significant difference in clinical outcome between SCTA01 and placebo in the treatment of high-risk outpatients diagnosed with COVID-19, and it was well tolerated. The trial was registered at ClinicalTrial.gov (NCT04709328)."

Clinical • Journal • P2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Fc-Modified Antibody in Hospitalized Severe COVID-19 Patients. (PubMed, Vaccines (Basel)) - " A global, randomized, double-blinded, and placebo-controlled phase II trial that investigated the clinical efficacy of SCTA01, an Fc-modified monoclonal antibody, in patients hospitalized with severe COVID-19 during the Delta variant wave was performed...Adverse events were comparable across all groups, and no treatment-related serious adverse event or antibody-dependent enhancement was reported. The Fc-modified antibody was safe but lacked significant clinical efficacy in vivo, likely due to the SARS-CoV-2 viral mutation."

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

The Efficacy and Safety of SCTA01 in Hospitalized Patients With Severe COVID-19 (clinicaltrials.gov) - P2/3 | N=103 | Terminated | Sponsor: Sinocelltech Ltd. | N=795 ➔ 103 | Recruiting ➔ Terminated; Preclinical test showed reduced efficacy

Enrollment change • Trial termination • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate Efficacy and Safety of the Combination of SCTA01 & SCTA01C in Outpatients With COVID-19 (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Sinocelltech Ltd. | N=434 ➔ 0 | Not yet recruiting ➔ Withdrawn

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

A Study to Evaluate Efficacy and Safety of the Combination of SCTA01 & SCTA01C in Outpatients With COVID-19 (clinicaltrials.gov) - P1/2; N=434; Not yet recruiting; Sponsor: Sinocelltech Ltd.

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety, tolerability, pharmacokinetics and immunogenicity of a monoclonal antibody (SCTA01) targeting SARS-CoV-2 in healthy adults: A randomized, double-blind, placebo-controlled, phase I study. (PubMed, Antimicrob Agents Chemother) - "In conclusion, SCTA01 up to 50mg/kg was safe and well-tolerated in healthy participants. Its PK parameters were nearly linear dose-proportional."

Clinical • Journal • P1 data • PK/PD data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

MAOP3: To Evaluate SCTA01 Treatment of High-risk Outpatients With COVID-19 (clinicaltrials.gov) - P2/3; N=690; Not yet recruiting; Sponsor: Sinocelltech Ltd.; Trial completion date: Dec 2021 ➔ Mar 2022; Trial primary completion date: Oct 2021 ➔ Jan 2022

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

The Efficacy and Safety of SCTA01 in Hospitalized Patients With Severe COVID-19 (clinicaltrials.gov) - P2/3; N=795; Recruiting; Sponsor: Sinocelltech Ltd.; Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

MAOP3: To Evaluate SCTA01 Treatment of High-risk Outpatients With COVID-19 (clinicaltrials.gov) - P2/3; N=690; Not yet recruiting; Sponsor: Sinocelltech Ltd.

Clinical • New P2/3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

Safety, Tolerability and Pharmacokinetics of SCTA01, an Anti-SARS-CoV-2 Monoclonal Antibody, in Healthy Chinese Subjects (clinicaltrials.gov) - P1; N=33; Completed; Sponsor: Sinocelltech Ltd.; Recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

The Safety and Efficacy of SCTA01 Against COVID-19 in Patients Admitted to High Dependence or Intensive Care (clinicaltrials.gov) - P2/3; N=560; Not yet recruiting; Sponsor: Sinocelltech Ltd.

Clinical • New P2/3 trial • Critical care • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

The Efficacy and Safety of SCTA01 in Hospitalized Patients With Severe COVID-19 (clinicaltrials.gov) - P2/3; N=795; Not yet recruiting; Sponsor: Sinocelltech Ltd.

Clinical • New P2/3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety, Tolerability and Pharmacokinetics of SCTA01, an Anti-SARS-CoV-2 Monoclonal Antibody, in Healthy Chinese Subjects (clinicaltrials.gov) - P1; N=33; Recruiting; Sponsor: Sinocelltech Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease

Safety, Tolerability and Pharmacokinetics of SCTA01, an Anti-COVID-19 Monoclonal Antibody, in Healthy Chinese Subjects (clinicaltrials.gov) - P1; N=33; Not yet recruiting; Sponsor: Sinocelltech Ltd.

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease