Glenmark Pharmaceuticals has launched a Phase III clinical trial to assess Favipiravir in combination with antiviral drug Umifenovir for the treatment of Covid-19 in India.
Earlier this month, Glenmark commenced a separate Phase III trial to assess favipiravir alone as a potential treatment for Covid-19 patients in the country.
Favipiravir and Umifenovir have unique mechanisms of action, and their combination is expected to improve efficacy by addressing high viral loads during the early stage of the disease.
Favipiravir has been approved in Japan since 2014 to treat new or re-emerging influenza virus infections. It inhibits viral replication by blocking RNA polymerase activity.
Meanwhile, Umifenovir is licensed in Russia and China for the treatment and prophylaxis of influenza A and B infections. It works by preventing the viral attachment to cells and has modulatory effects on the immune system, triggering interferon-production.
In-vitro, the drugs demonstrated the ability to inhibit viral infection and demonstrated efficacy in Covid-19 trials.
Glenmark Pharmaceuticals Clinical Development Global Specialty/Branded Portfolio vice-president and head Dr Monika Tandon said: “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 amongst medical professionals and healthcare workers by reducing the duration of virus shedding from treated patients.”
The new Phase III study, named FAITH, will enrol 158 hospitalised patients with moderate Covid-19 infection. Participants will be given Favipiravir and Umifenovir or Favipiravir with standard supportive care.
The treatment duration is 14 days and patients will be discharged following clinical cure and two consecutive negative tests for Covid-19.
Results from the Phase III Favipiravir monotherapy study are expected by July or August this year.