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.
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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.