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October 20, 2020

Edesa Biotech gets FDA approval for EB05 trial to treat Covid-19

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

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 hospitalised patients with Covid-19.

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Edesa began the site initiation process at hospitals across the US.

Earlier, Health Canada 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) signalling, a key mediator of inflammation responsible for acute lung injury triggered by SARS-CoV1 and influenza viruses.

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

According to the US Centers for Disease Control (CDC ), 20%-42% of hospitalised Covid-19 patients develop ARDS, with 67%-85% of patients admitted to the ICU. Mortality rates are supposedly 39%-72% among those admitted to the ICU.

Phase II / III study will be adaptive, multicentre, randomised, double-blind, placebo-controlled, analysing the efficacy and safety of EB05 in hospitalised patients 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.”

Related Companies

Free Whitepaper
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What is the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry?

While wanting to protect the country from being overwhelmed by Omicron, China’s adherence to a Zero-COVID policy is resulting in a significant economic downturn. COVID outbreaks in Shanghai, Beijing and many other Chinese cities will impact 2022’s economic growth as consumers and businesses experience rolling lockdowns, leading to a slowdown in domestic and international supply chains. China’s Zero-COVID policy is having a demonstrable impact on consumer-facing industries. Access GlobalData’s new whitepaper, China in 2022: the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry, to examine the current situation in Shanghai and other cities in China, to better understand the worst-affected industry sectors, foodservice in particular, and to explore potential growth opportunities as China recovers. The white paper covers:
  • Which multinational companies have been affected?
  • What is the effect of lockdowns on foodservice?
  • What is the effect of lockdowns on Chinese ports?
  • Spotlight on Shanghai: what is the situation there?
  • How have Chinese consumers reacted?
  • How might the Chinese government react?
  • What are the potential growth opportunities?
by GlobalData
Enter your details here to receive your free Whitepaper.

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