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Pfizer’s Protease Inhibitor New Drug Development for SARS-CoV-2 for 2021 Looks Promising

Image Credit: Alexyz3d / Shutterstock

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.

References:

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

Considerations for the Business of Early Stage Biotech

Blog Post by: Lawrence Jones, Ph.D.

In the business of early-stage biotech perhaps“competing is no longer about creating dominance in scale-intensive industries; it’s about producing elegant, refined products and services in imagination-intensive Industries” (Martin, 2004, p.7). Dean Roger Martin, from the Rotman School of Business at the University of Toronto, published this statement over a decade ago was echoing new strategy to competing in the global economy.Martin (2004) adds that competition will be evaluated more during this era of post-2004 by the design revolution in business (p.7).The design revolution views the market through the lens of the application of design thinking (p.7). Martin mentions that the conversion of heuristics to algorithms mainly defined value creation in the 20th century.

Jones (2016) adds that an algorithm is a process or set of rules to be followed in calculations or other problem-solving operations. Martin (2004) posits that business people need to become more like designers that are masters of heuristics rather than managers of algorithms (p.7).This thought may not work well for biotechnology scientists conducting laboratory research. However, this may suggest that in the 21st century, design skills and business skills are converging. Heuristics play essential roles in both problem-solving and decision-making.

Brown and Wyatt (2010) explain how design thinking evolved from the merger of David Kelley Design and ID Two, which formed IDEO in 1991 (p.33).Within a decade, IDEO began consulting for organizational design and essentially began to design more consumer experiences than consumer products (p.33).David Kelly, the founder of Stanford’s design school, coined the phrase design thinking when explaining what designers do (p.33).Overall design thinking draws from overlapping life experiences by general problem-solving.

According to Brown and Wyatt (2010), “design thinking process is the best thought of a system of overlapping spaces rather than a sequence of orderly steps” (p.33). “There are three spaces to keep in mind: inspiration, ideation, and implementation”.“Inspiration is a problem or opportunity that motivates the search for solutions” (p.33). “Ideation is the process of generating, developing, and testing ideas and implementation as the path that leads from the project stage into people’s lives” (p. 33).

Berkun (2007) advises in the book “The Myth of Innovation,” that there are challenges to innovation such as finding an idea, developing a solution, sponsorship and funding, reproduction, reaching potential customers, beating competitors, timing, and keeping the lights on are hurdles to overcome (pp. 44-45).Design thinking applied to each of these challenges will provide potential options.Design thinking, according to Silvers (2013),is scalable and flexible.The thought is that this process, particularly for any non-profit, has the potential to be cost-effective regardless of the operation.As a human-centered process of innovation, design thinking can reveal a multitude of methods and talent amongst the design team, which can create change unimaginable until the process launches.

The pace of innovation can produce fears and uncertainties for the general consumer, but new approaches to reduce the anxieties for consumers are great ways to design thinking to play pivotal roles.Design thinking is disruptive, and it may be an enabler to grasp the pace of innovation.The future holds that people must come first. The way to design will start by observing the people.

References

Berkun, S. (2007). The Myths of Innovation. Canada.

Brown, T., & Wyatt, J. (2010). Design thinking for social innovation. Stanford Social Innovation Review. 29-35

Jones, L. (November 10, 2016). Rethinking and Refining Business Thinking. The Transcript. Hopkinsbio.org. Hopkins Biotech Network, Baltimore, Maryland

Martin, R. (2004, Winter). The design of business. Rotman Management, 5(1), 6-10.

Silvers, D.M. (December 10, 2013). Design Thinking: A Powerful Tool for Your Non-profit. NTEN.org

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