Delving into the Latest Updates on SARS-CoV-2 IgY antibody(Shenzhen Ellen-Sven Precision Medicine Institute) with Synapse

Overview

Basic Info

Drug Type

Biological products

Synonyms-

Target

SARS-CoV-2 S protein

Mechanism

SARS-CoV-2 S protein inhibitors(Coronavirus spike glycoprotein inhibitors)

Therapeutic Areas

Infectious Diseases

Active Indication

Coronavirus Infections

Inactive Indication-

Originator Organization

Shenzhen Allen Sven Precision Medicine Institute

Active Organization

Shenzhen Allen Sven Precision Medicine Institute

Inactive Organization-

Drug Highest PhasePreclinical

First Approval Date-

Regulation-

Author: Inman, David ; Chow, Sophia ; Gonzalez-Rojas, Yaneicy ; Yeh, Wendy W ; Sager, Jennifer E ; Wang, Qianwen ; Skingsley, Andrew ; Shapiro, Adrienne E ; Hussain, Rubaba ; Gaffney, Leah A ; Moya, Jaynier ; Pang, Phillip S ; Hong, David K ; Kohli, Anita ; Parikh, Naval ; Alexander, Elizabeth L ; Cebrik, Deborah ; Acloque, Jude ; Free, Almena ; Noormohamed, Nadia ; Austin, Daren ; Nader, Ahmed ; Peppercorn, Amanda ; Juarez, Erick ; Agostini, Maria L ; Mogalian, Erik ; Sarkis, Elias ; Parra, Sergio

Abstract:

Background:

Convenient administration of coronavirus disease 2019 (COVID-19) treatment in community settings is desirable. Sotrovimab is a pan-sarbecovirus dual-action monoclonal antibody formulated for intravenous (IV) or intramuscular (IM) administration for early treatment of mild/moderate COVID-19.

Method:

This multicenter phase 3 study based on a randomized open-label design tested the noninferiority of IM to IV administration according to an absolute noninferiority margin of 3.5%. From June to August 2021, patients aged ≥12 years with COVID-19, who were neither hospitalized nor receiving supplemental oxygen but were at high risk for progression, were randomized 1:1:1 to receive sotrovimab as a single 500-mg IV infusion or a 500- or 250-mg IM injection. The primary composite endpoint was progression to (1) all-cause hospitalization for >24 hours for acute management of illness or (2) all-cause death through day 29.

Results:

Sotrovimab 500 mg IM was noninferior to 500 mg IV: 10 (2.7%) of 376 participants vs 5 (1.3%) of 378 met the primary endpoint, respectively (absolute adjusted risk difference, 1.06%; 95% CI, −1.15% to 3.26%). The 95% CI upper limit was lower than the prespecified noninferiority margin of 3.5%. The 250-mg IM group was discontinued early because of the greater proportion of hospitalizations vs the 500-mg groups. Serious adverse events occurred in <1% to 2% of participants across groups. Four participants experienced serious disease-related events and died (500 mg IM, 2/393, <1%; 250 mg IM, 2/195, 1%).

Conclusions:

Sotrovimab 500-mg IM injection was well tolerated and noninferior to IV administration. IM administration could expand outpatient treatment access for COVID-19.

Clinical Trials Registration:

ClinicalTrials.gov: NCT04913675.

18 Nov 2021·The New England journal of medicineQ1 · MEDICINE

Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab

Q1 · MEDICINE

Article

Author: Pang, Phillip S. ; Zheng, Hanzhe ; Scott, Nicola ; Tipple, Craig ; Gonzalez-Rojas, Yaneicy ; Shapiro, Adrienne E. ; Hebner, Christy M. ; Gupta, Anil ; Aldinger, Melissa ; Crespo Casal, Manuel ; Brinson, Cynthia ; Free, Almena ; Sarkis, Elias ; Alexander, Elizabeth ; Peppercorn, Amanda ; Solis, Joel ; Moya, Jaynier ; Juarez, Erick ; Sager, Jennifer ; Mogalian, Erik ; Cathcart, Andrea L. ; Falci, Diego R.

BACKGROUND:

Coronavirus disease 2019 (Covid-19) disproportionately results in hospitalization or death in older patients and those with underlying conditions. Sotrovimab is a pan-sarbecovirus monoclonal antibody that was designed to prevent progression of Covid-19 in high-risk patients early in the course of disease.

METHODS:

In this ongoing, multicenter, double-blind, phase 3 trial, we randomly assigned, in a 1:1 ratio, nonhospitalized patients with symptomatic Covid-19 (≤5 days after the onset of symptoms) and at least one risk factor for disease progression to receive a single infusion of sotrovimab at a dose of 500 mg or placebo. The primary efficacy outcome was hospitalization (for >24 hours) for any cause or death within 29 days after randomization.

RESULTS:

In this prespecified interim analysis, which included an intention-to-treat population of 583 patients (291 in the sotrovimab group and 292 in the placebo group), 3 patients (1%) in the sotrovimab group, as compared with 21 patients (7%) in the placebo group, had disease progression leading to hospitalization or death (relative risk reduction, 85%; 97.24% confidence interval, 44 to 96; P = 0.002). In the placebo group, 5 patients were admitted to the intensive care unit, including 1 who died by day 29. Safety was assessed in 868 patients (430 in the sotrovimab group and 438 in the placebo group). Adverse events were reported by 17% of the patients in the sotrovimab group and 19% of those in the placebo group; serious adverse events were less common with sotrovimab than with placebo (in 2% and 6% of the patients, respectively).

CONCLUSIONS:

Among high-risk patients with mild-to-moderate Covid-19, sotrovimab reduced the risk of disease progression. No safety signals were identified. (Funded by Vir Biotechnology and GlaxoSmithKline; COMET-ICE ClinicalTrials.gov number, NCT04545060.).

100 Deals associated with SARS-CoV-2 IgY antibody(Shenzhen Ellen-Sven Precision Medicine Institute)

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