Pfizer COVID-19 clinical trials: antiviral PF-07321332 and Pfizer antiviral PF-07304814
… Pfizer researching oral and IV COVID-19 antiviral therapies PF-07321332 and PF-07304814

Pfizer Launches Phase 1 Clinical Trial For Oral COVID-19 Antiviral Drug

Pfizer seeks to expand COVID-19 drug portfolio by creating novel antivirus therapies

John G. Baresky

Global pharmaceutical giant Pfizer (NYSE: PFE) is evaluating antiviral product pipeline candidates to treat COVID-19 via oral administration as well as IV therapy.

The promising new oral drug candidate, designated as PF-07321332, is being evaluated in a Phase 1, randomized, double-blind, sponsor-open, placebo-controlled, single- and multiple-dose escalation study to evaluate its safety, tolerability, and pharmacokinetics in healthy adult patients.

The experimental compound is classified as a protease inhibitor. Protease inhibitors prevent viruses from multiplying by selectively binding to viral proteases and blocking the proteolytic cleavage of protein precursors that are required for viruses to replicate.

Protease inhibitors are presently used as FDA-approved therapies to treat HIV/AIDS and Hepatitis C or “Hep-C”. They are being further explored for use to treat other viral pathogens such as malaria.

Pfizer is also hard at work on developing another protease inhibitor, PF-07304814, that is administered by IV infusion. PF-07304814 is engaged in a phase 1b clinical trial in patients diagnosed with Covid-19. It is a 2-part study exclusively focused on hospitalized COVID-19 patients.

The first portion of the study is to assess safety, tolerability, PK and clinical performance levels of escalating doses of PF-07304814 administered as 24-hour IV infusion. The second part of the study is to determine the safety, tolerability, PK and clinical performance levels of escalating doses of PF- 07304814 administered by 120-hour infusion.

Pfizer has been at the forefront of the COVID-19 pandemic from the start. It is the first company, along with its partner BioNTech SE (NASDAQ: BNTX), to develop a COVID-19 vaccine approved by U.S. Food and Drug Administration (FDA).

Both PF-07321332 and PF-07304814 are extraordinarily valuable assets for Pfizer and the medical community. If approved, Pfizer’s market access and sales strategy could easily center on these basic elements for the oral antiviral agent:

  • Individuals unable to be vaccinated due to other healthcare issues would have an important option if they were diagnosed with COVID-19
  • The product would be a go-to option in the event vaccinated individuals became infected by the coronavirus
  • An oral agent could prevent persons from being admitted to hospitals or needing to be treated with IV therapies in an outpatient setting -both more costly and less convenient than an oral therapy option
  • Payers would embrace the care, cost and convenience attributes of the oral formulation for their members

An additional IV administered COVID-19 antiviral agent helps widen the selection of products clinicians can choose from to optimize clinical outcomes based on individual patient factors.

While its cost and convenience attributes would not directly align with the oral formulation, the IV version would still be embraced by patients, clinicians and payers to avoid having patients admitted to hospitals for lengthy treatment stays.

Pfizer is a global leader in developing vaccines and antiviral therapies to prevent or treat COVID-19 infection
Pfizer is a global leader in developing vaccines and antiviral therapies to prevent or treat COVID-19 infection

In the United States, over 2,900 medical professionals have died as a result of COVID-19 infection and more than 540,000 persons overall have had their lives taken by the coronavirus across the nation.

COVID-19 is far from being neutralized as a healthcare danger as outbreaks continue to occur within the United States and throughout the world. The medical and research community continues to learn about this persistent and deadly pathogen; its variants pose further clinical challenges and lethal threats worldwide.

Not all patients respond well to existing treatments and the anticipated, natural mutation of the coronavirus could require a new array of tests and medications to overcome them. The progress in the development and manufacturing of a variety of pharmaceutical products to treat COVID-19 is encouraging and significantly important.

Learn more about what has been accomplished and what is underway from this helpful list of articles featuring strategic insights on enterprises developing and manufacturing COVID-19 antiviral therapy, diagnostics and vaccines:

COVID-19 Antivirals:

COVID-19 Diagnostics:

COVID-19 Vaccines:

Moving forward, these and other companies have enormous opportunities to achieve clinical and commercial growth through the development of future COVID-19 therapies. Their success is highly anticipated by consumers, patients, medical professionals, healthcare provider organizations, payers, governments and investors.

Beginning with the approval of their highly successful COVID-19 vaccine, Pfizer continues its clinical innovation and leadership role in the battle against the coronavirus.

Thank you for reading this story

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