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Edesa Biotech Gets FDA Approval for Phase II Trial of EB05 for Covid-19 Treatment

Edesa Biotech Gets FDA Approval for Phase II Trial of EB05 for Covid-19 Treatment

Published : 30 Oct 2020

Edesa Biotech gets FDA approval for Phase II trial of EB05 for Covid-19 treatment



Drug Name: NI-0101

Biopharma firm Edesa Biotech has received clearance from the US Food and Drug Administration (FDA) to initiate the Phase II part of Phase II/III clinical trial of its investigational drug EB05 to treat hospitalized patients with Covid-19.

 

Edesa has started the site initiation process at hospitals in the US.

 

Earlier, Health Canada had approved the Phase II/III study protocol.

 

The experimental monoclonal antibody, EB05 has the potential to regulate the overactive immune response associated with Acute Respiratory Distress Syndrome (ARDS), the main cause of death in Covid-19 patients.

 

EB05 hinders toll-like receptor 4 (TLR4) signaling, which is a key mediator of inflammation that is responsible for acute lung injury triggered by SARS-CoV1 and Influenza viruses.

 

The treatment aims to suppress fluid accumulation, lung injury, and inflammation, which will in turn help to cut down the number of ICU patients and intubation/ventilation procedures.

 

According to the US Centers for Disease Control (CDC), 20 to 42% of hospitalized Covid-19 patients develop ARDS. Of this, 67 to 85% of patients get admitted to the ICU. Mortality rates are observed at 39 to 72% among those admitted to the ICU.

 

Phase II/III study will be adaptive, multicentre, randomized, double-blind, placebo-controlled, and will analyze the efficacy and safety of EB05 in hospitalized patients with or are at risk of ARDS.

 

During the trial, patients will be infused intravenously with a single dose of EB05 or placebo.

 

On obtaining promising results in the Phase II trial, Edesa plans to carry on with the Phase III trial.

 

Edesa CEO Dr. Par Nijhawan said: “Our EB05 study has been deemed safe to proceed by the FDA, marking another milestone in our plans to begin patient enrolment. We believe our drug candidate has the potential to inhibit a key proinflammatory pathway linked to some of the worst effects of the disease.”



Source: GlobalData.com