Glenmark to start phase 3 of COVID-19 clinical trial on hospitalised patients
Glenmark study will examine whether early administration of a combination of Favipiravir and Umifenovir, both acting by different mechanisms, enhances antiviral efficacy on COVID-19 patients
- May 26, 2020,
- Updated May 26, 2020 5:10 PM IST
Mumbai-headquartered Glenmark Pharmaceuticals announced on Tuesday that it has to commence a new phase three of the clinical trial on a combination of two anti-viral drugs - Favipiravir and Umifenovir - on hospitalised patients of moderate COVID-19 in India. It says it has received the approval from the Indian regulator to initiate the study. The combination study which will be called the FAITH trial will look to enroll 158 hospitalised patients of moderate COVID-19 in India.
"The two antiviral drugs have different mechanism of action, and their combination may demonstrate improved treatment efficacy by effectively tackling high viral loads in patients during early stage of disease," a note issued by the company says.
Early administration of a combination of antiviral medications acting by different mechanisms is desirable for the treatment of COVID-19, since the viral load of SARS-CoV-2 peaks around the time of symptom onset. Thus, the note says, combining antiviral drugs could result in greater clinical effectiveness and could also prevent, or delay, the emergence of resistance. Favipiravir is an oral antiviral drug approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections.
Also read: Coronavirus update: 4 vaccines may soon enter clinical trial stage, says Harsh Vardhan
It is being described as a unique mechanism of action by which it inhibits viral replication. "Umifenovir impedes the viral attachment to cells and acts as a viral entry inhibitor. Additionally it exhibits modulatory effects on the immune system and induces interferon-production. Hence a combined use of Favipiravir and Umifenovir acting on different mechanisms offers a comprehensive antiviral cover on pre-entry and post-entry life-cycle of the SARS-CoV-2 virus. Both Favipiravir and Umifenovir inhibited virus infection in vitro and have shown efficacy in COVID-19 clinical trials," the note says.
The current Glenmark study will examine whether early administration of a combination of Favipiravir and Umifenovir, both acting by different mechanisms, enhances antiviral efficacy on COVID-19 patients.
Also read: Coronavirus vaccine: List of 5 COVID-19 treatment frontrunners
The note quotes Dr. Monika Tandon, Vice President & Head, Clinical Development Global Specialty/Branded Portfolio, Glenmark Pharmaceuticals as saying: "Combining antiviral agents that have a good safety profile and act on different stages of viral life-cycle is an effective treatment approach to rapidly suppress initial high viral load and lead to overall improvement in clinical parameters. We consider Glenmark's study will be pivotal in leading to identification of highly effective and safe treatments against COVID-19 in India. Beyond its many potential patient treatment benefits, we also hope the combination therapy will reduce infection risk among medical professionals and healthcare workers by reducing the duration of virus shedding from treated patients."
Mumbai-headquartered Glenmark Pharmaceuticals announced on Tuesday that it has to commence a new phase three of the clinical trial on a combination of two anti-viral drugs - Favipiravir and Umifenovir - on hospitalised patients of moderate COVID-19 in India. It says it has received the approval from the Indian regulator to initiate the study. The combination study which will be called the FAITH trial will look to enroll 158 hospitalised patients of moderate COVID-19 in India.
"The two antiviral drugs have different mechanism of action, and their combination may demonstrate improved treatment efficacy by effectively tackling high viral loads in patients during early stage of disease," a note issued by the company says.
Early administration of a combination of antiviral medications acting by different mechanisms is desirable for the treatment of COVID-19, since the viral load of SARS-CoV-2 peaks around the time of symptom onset. Thus, the note says, combining antiviral drugs could result in greater clinical effectiveness and could also prevent, or delay, the emergence of resistance. Favipiravir is an oral antiviral drug approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections.
Also read: Coronavirus update: 4 vaccines may soon enter clinical trial stage, says Harsh Vardhan
It is being described as a unique mechanism of action by which it inhibits viral replication. "Umifenovir impedes the viral attachment to cells and acts as a viral entry inhibitor. Additionally it exhibits modulatory effects on the immune system and induces interferon-production. Hence a combined use of Favipiravir and Umifenovir acting on different mechanisms offers a comprehensive antiviral cover on pre-entry and post-entry life-cycle of the SARS-CoV-2 virus. Both Favipiravir and Umifenovir inhibited virus infection in vitro and have shown efficacy in COVID-19 clinical trials," the note says.
The current Glenmark study will examine whether early administration of a combination of Favipiravir and Umifenovir, both acting by different mechanisms, enhances antiviral efficacy on COVID-19 patients.
Also read: Coronavirus vaccine: List of 5 COVID-19 treatment frontrunners
The note quotes Dr. Monika Tandon, Vice President & Head, Clinical Development Global Specialty/Branded Portfolio, Glenmark Pharmaceuticals as saying: "Combining antiviral agents that have a good safety profile and act on different stages of viral life-cycle is an effective treatment approach to rapidly suppress initial high viral load and lead to overall improvement in clinical parameters. We consider Glenmark's study will be pivotal in leading to identification of highly effective and safe treatments against COVID-19 in India. Beyond its many potential patient treatment benefits, we also hope the combination therapy will reduce infection risk among medical professionals and healthcare workers by reducing the duration of virus shedding from treated patients."