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August 12, 2020

Romark begins Phase III trial of Covid-19 drug candidate

Biopharmaceutical company Romark Laboratories has commenced Phase III trial of its new investigational drug candidate NT-300 (nitazoxanide).

Biopharmaceutical company Romark has commenced a Phase III trial of its new investigational drug candidate NT-300 (nitazoxanide) for the treatment of mild or moderate Covid-19.

The multicentre, randomised, double-blind trial of the NT-300 drug containing nitazoxanide extended-release tablets will involve the participation of nearly 800 people aged 12 and older with coronavirus-related fever and respiratory symptoms.

These participants will be randomised with either NT-300 or placebo twice a day for five days.

According to the company, efficacy analysis will examine those subjects who have laboratory-confirmed SARS-CoV-2 infection, a virus that causes Covid-19.

The primary endpoint will be achieved if there is a reduction in the recovery time compared with placebo, while the secondary endpoint is a reduction in the rate of progression to severe Covid-19 illness when compared to placebo.

Romark chief medical and scientific officer Jean-François Rossignol said: “As the Covid-19 pandemic continues to take a toll on our collective health, economy and well-being, we are pleased to broaden our NT-300 Covid-19 clinical programme through the initiation of a third trial evaluating NT-300 as a treatment in addition to our two ongoing prophylactic trials.

“Along with vaccines and treatments for severe illness, oral treatments that can be given outside of a hospital setting to prevent infection or used as soon as symptoms appear to reduce the duration of illness and prevent hospitalisations are desperately needed.”

Nitazoxanide, which is an active ingredient in NT-300, prevents the duplication of a wide range of respiratory viruses, including SARS-CoV-2.

Earlier this year, Romark began two Phase III clinical trials for the prevention of coronavirus, as well as other viral respiratory illnesses.

Romark anticipates sharing the results of these trials by the end of this year.

In April 2013, Romark started patient enrolment in a Phase III trial of influenza drug NT-300.

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