New Delhi: Glenmark Pharmaceuticals announced on Tuesday that it will commence another new Phase 3 clinical trial on a combination of two anti-viral drugs Favipiravir and Umifenovir in hospitalized patients of moderate COVID-19 in India.
Glenmark has received approval from the Indian regulator to initiate the study.
The combination study which will be called the FAITH trial will look to enroll 158 hospitalized patients of moderate COVID-19 in India.
Early treatment with combination therapy will be evaluated for safety and efficacy as it is emerging as an effective approach in shortening duration of virus shedding, decreasing cytokine response, and facilitating early discharge of patients.
Glenmark said the antivirals with different mechanisms of action could complement and enhance efficacy against COVID-19.
Glenmark also continues its Phase 3 clinical trials on antiviral Favipiravir monotherapy for COVID-19 patients in India.
The company has announced a new randomized, open-label study to test the combined efficacy of two antiviral drugs Favipiravir and Umifenovir as a potential COVID-19 treatment strategy.
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.
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 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. It has a unique mechanism of action by which it inhibits viral replication.
It is converted into an active phosphoribosylated form (favipiravir-RTP) in cells and recognized as a substrate by viral RNA polymerase, thereby inhibiting RNA polymerase activity that is required for viral replication.
Umifenovir is another oral antiviral drug licensed for the treatment and prophylaxis of influenza A and B infections in Russia and China.
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-2virus.
Both Favipiravir and Umifenovir inhibited virus infection invitro6and have shown efficacy in COVID-19 clinical trials
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-19patients.
Novavax begins clinical trial of Covid-19 vaccine in Australia
US-based biotechnology company Novavax has started enrolling participants in Australia for a clinical trial of its coronavirus vaccine candidate, NVX-CoV2373.
Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July 2020, Novavax said on Monday.
"Administering our vaccine in the first participants of this clinical trial is a significant achievement, bringing us one step closer toward addressing the fundamental need for a vaccine in the fight against the global Covid-19 pandemic," said Stanley Erck, President and Chief Executive Officer of Novavax.
"We look forward to sharing the clinical results in July and, if promising, quickly initiating the Phase 2 portion of the trial."
The Phase 1/2 clinical trial is being conducted in two parts. The Phase 1 portion of the trial is enrolling approximately 130 healthy participants 18 to 59 years of age at two sites in Australia.
The Phase 2 portion is expected to be conducted in multiple countries, including the US, and would assess immunity, safety and Covid19 disease reduction in a broader age range.
The trial is being supported by the recently announced funding arrangement with the Coalition for Epidemic Preparedness Innovations (CEPI), an innovative partnership between public, private, philanthropic, and civil society organizations, launched at Davos in 2017, to develop vaccines to stop future epidemics.
NVX-CoV2373 includes Novavax' proprietary Matrix-M adjuvant to enhance immune responses and stimulate high levels of neutralising antibodies.
Novavax said it identified NVX-CoV2373 as its lead SARS-CoV-2 candidate following pre-clinical testing that demonstrated high immunogenicity and high levels of neutralising antibodies.
The availability of a safe and effective vaccine for COVID-19 is well-recognised as a key tool to control the pandemic. At the same time, the efforts needed to rapidly develop, evaluate and produce this at scale are enormous.
According to the WHO, it is important to evaluate as many vaccines as possible as we cannot predict how many will turn out to be viable.
To increase the chances of success, it is critical to test all candidate vaccines until they fail, the WHO said, adding that it is working to ensure that all of them have the chance of being tested at the initial stage of development.
Over 120 vaccines have been proposed across the world including in India. There are currently several vaccines in clinical evaluation, and about 70 in pre-clinical evaluation.