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October 7, 2021

Covicept commences Phase II oral Covid-19 drug trial in Brazil

The trial will analyse the safety and efficacy of PSJ-539 in newly diagnosed Covid-19 patients. 

Covicept Therapeutics has begun a Phase II clinical trial of its oral antiviral drug candidate, PSJ-539, in mild-to-moderate Covid-19 patients in Brazil.

The trial is currently enrolling subjects with a goal to recruit up to 150.

A once-daily oral pill, PJS-539, can hinder the attachment and replication of SARS-CoV-2 and other ribonucleic acid (RNA) viruses.

The randomised, double-blind, multicentre, placebo-controlled Phase II trial will assess the drug’s safety and efficacy in subjects with recently diagnosed Covid-19.

Subjects will be given once daily dose of PSJ-539 for ten days.

The impact of two varying doses of the antiviral drug on viral load versus placebo will be the trial’s primary goal.

Hospitalisation frequency and mechanical ventilation requirements will be included as secondary goals.

The company expects to report results from the study by the end of the year.

Covicept Therapeutics co-founder, chairman and CEO professor Sam Tsimikas: “It is a significant milestone for this programme to move into clinical development in less than a year since Covicept was founded.

“Our team, together with Forbion’s operational and financial support, provides the necessary synergy to bring this medicine to patients infected with SARS-CoV-2 as quickly as possible.”

Various host-dependent mechanisms through which PSJ-539 hinders viral infections were unveiled by Covicept, demonstrating the drug’s potential as a broad-spectrum antiviral therapy acting on RNA viruses.

In preclinical SARS-CoV-2-induced pneumonia models, PSJ-539 was demonstrated to possess robust anti-inflammatory, as well as anti-fibrotic properties.

The drug’s peculiar mechanism of action could also aid in preventing or reducing the development of resistance to vaccines and anti-viral therapies.

Covicept, a portfolio company of life sciences venture capital firm Forbion, creates therapies for the treatment of diseases caused by various RNA viruses, such as SARS-CoV-2.

Forbion is offering operational support and extended seed funding worth $2.3m to Covicept.

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