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By Lawrence Jones, PhD
Protease inhibitor technology used commonly as a strategy to treat HIV and hepatitis C is now a strategy for SARS-CoV-2 antiviral therapy development. Researchers for SARS-CoV-2 have focused on “main protease (Mpro) which plays a dominant role in processing CoV-encoded polyproteins which mediate the assembly of replication-transcription machinery and is thus recognized as an ideal antiviral target (Cui, et. al, 2020.” The SARS-CoV-2 antiviral therapy development may consist of repurposed drugs as the push for a breakthrough is not only a goal by Pfizer but other biopharma companies in pursuit. “The first protease inhibitor to be approved by the US Food and Drug Administration (FDA) was saquinavir, in December 1995, and within months, two other protease inhibitors, ritonavir, and indinavir were approved (Cully, 2018).”
So far, Pfizer has been able to deliver to the public. Thus, the company has been a significant player during the SARS-CoV-2 vaccine production and distribution with effective outcomes regarding their vaccine efficacy and ability to produce the quantity of vaccine needed. Pfizer’s protease inhibitor outlook for the first U.S.-approved SARS-CoV-2 therapeutics is fast-tracked to their initial clinical phase 1 trial. Pfizer’s early stage one clinical trial on an oral antiviral therapy that can treat a SARS-CoV-2 patient effectively is now on the horizon. The quest to get the SARS-CoV-2 pandemic under control is continuing with urgency and caution.
The aim of the drug is for the first developing symptoms, which according to Pfizer (March 23, 20201), would make it the first oral antiviral treatment of its kind for coronavirus. Pfizer (March 23, 2021) “the trial is randomized and includes placebo groups with both single and multiple-dose studies.” What is promising is that the Pfizer company “is also studying an intravenous antiviral to treat SARS-CoV-2, which will become an option for some hospitalized patients over time.” Pfizer’s “PF-07321332 “protease inhibitor” has been formulated to attack the “spine” of the SARS-CoV-2 virus and stop it replicating in our nose, throats, and lungs.”
Pfizer’s Chief Scientific Officer, Mikael Dolsten reports that he is hopeful that their early raises the prospects of a cure for future pandemic threats. For now, laboratory “invitro” for animal tolerance is of the foremost importance before being tested in humans. Clinical trials will be intensive, and the screening and dosing steps and outcomes of the dosing step will be crucial for determining the drug’s safety and tolerability. The upcoming months of 2021 and early 2022 look very promising for technology combination therapies to mitigate SARS-CoV-2 infections.
Butz, B. (March 23, 2021). Pfizer launches trial for novel oral SARS-COV-2 therapeutic. https://www.drugdiscoverytrends.com/pfizer-launches-phase-1-trial-for-novel-oral-SARS-CoV-2-therapeutic/
Cui, W., Yang, K., & Yang, H. (2020). Recent progress in the drug development targeting SARS-CoV-2 main protease as treatment for COVID-19. Frontiers in molecular biosciences,
Cully, M. (November 28, 2018). Protease inhibitors give wings to combination therapy. https://www.nature.com/articles/d42859-018-00015-7
Holzberg, E. (March 23, 2021). Pfizer Testing A Pill To Treat Covid. Pfizer Testing A Pill To Treat Covid (forbes.com)
Lucy, P. (April 28, 2021). Pfizer CEO says oral SARS-COV-2 pill could be ready by the end of the year. https://www.pmlive.com/pharma_news/pfizer_ceo_says_oral_SARS-CoV-2_pill_could_be_ready_by_the_end_of_the_year_1368720
Pfizer (March 23, 2021). Pfizer initiates phase 1 study of novel oral antiviral therapeutic agent against sars-cov-2. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-initiates-phase-1-study-novel-oral