Lufotrelvir

Although the authorization of numerous vaccines and their deployment around the world has COVID-19 on the run, the biopharma industry and researchers aren’t resting on their laurels. With the rise of mutant strains of SARS-CoV-2 and the unlikelihood of 100% compliance in getting vaccines out, investigators are focusing on developing even better vaccines and new drugs that might be able to knock back the disease. Here’s a look. Pfizer Launching Phase I Trial of Antiviral Drug Against COVID-19 Pfizer announced they are launching a single ascending dose-ranging Phase I study in healthy adults, testing its investigational, novel oral antiviral against SARS-CoV-2. The trial will be run in the U.S. The drug, PF-07321332, is a SARS-CoV2-3CL protease inhibitor and has shown potent antiviral activity in laboratory assays against SARS-CoV-2, as well as against other coronaviruses. “Tackling the COVID-19 pandemic requires both prevention via vaccine and targeted treatment for those who contract the virus,” said Mikael Dolsten, Pfizer’s chief scientific officer and president, Worldwide Research, Development and Medical. “Given the way that SARS-CoV-2 is mutating and the continued global impact of COVID-19, it appears likely that it will be critical to have access to therapeutic options both now and beyond the pandemic. We have designed PF-07321332 as a potential oral therapy that could be prescribed at the first sign of infection, without requiring that patients are hospitalized or in critical care. At the same time, Pfizer’s intravenous antiviral candidate is a potential novel treatment option for hospitalized patients. Together, the two have the potential to create an end-to-end treatment paradigm that complements vaccination in cases where disease still occurs.” The company is also investigation an intravenously administered protease inhibitor, PF-07304814, currently in a Phase Ib trial in hospitalized COVID-19 patients. Kaleido Announced Positive Results in Mild-to-Moderate COVID-19 Study Kaleido Biosciences, headquartered in Lexington, Mass., reported positive data from a non-IND study of KB109 in patients with mild-to-moderate COVID-19. The analysis showed a decrease in overall COVID-19 related healthcare utilization, which they defined as hospitalizations, emergency room visits, and urgent care visits. The trial also demonstrated a significant decrease in recovery time for patients 45 years of age and older or with one or more comorbidities who received KB109 and self-supportive care compared to patients with self-supportive care alone. KB109 is a novel, oral product based on the company’s Microbiome Metabolic Therapy (MMT) platform. The microbiome is the trillions of microorganisms—bacteria, viruses, fungi—that live in and on the human body. MMTs are designed to drive the function and distribution of the microbiome’s existing microbes to decrease or increase product of metabolites. The company’s MMTs are targeted, synthetic glycans that have limited systemic exposure and are selectively metabolized by enzymes in the microbiome. “Despite historic progress in advancing COVID-19 vaccinations, new strains of the virus continue to emerge, necessitating safe, orally available therapies for patients around the world,” said Dan Menichella, president and chief executive officer of Kaleido. “Based on these results, we are excited to advance KB109—which can be administered at home—into an IND to assess whether it may help improve patient outcomes, particularly among more vulnerable populations.” Moderna Working on an Even Better COVID-19 Vaccine Although Moderna already has a very effective COVID-19 vaccine, and it is projecting 2021 sales of more than $18 billion, the company is continuing to work on improvements. They have recently dosed the first participants in a Phase I study of their next-generation COVID-19 vaccine. The vaccine is dubbed mRNA-1283. It appears to be refrigerator stable—the first-generation vaccine requires cold-chain storage, although not as cold as the Pfizer-BioNTech vaccine—and a single dose instead of the current two-dose regimen. They’re also testing it as a two-dose regimen. They’re also evaluating mRNA-1283 as a booster with the current vaccine to determine if it will increase protection. “We are pleased to begin this Phase I study of our next generation COVID-19 vaccine candidate,” stated Stephane Bancel, Moderna’s chief executive officer. “Our investments in our mRNA platform have enabled us to develop this next generation vaccine candidate, which is a potential refrigerator-stable vaccine that could facilitate easier distribution and administration in a wider range of settings, including potentially for developing countries. We remain committed to helping address this ongoing public health emergency.” UC San Diego Launches Trial to Determine if Mushrooms Can Treat COVID-19 Researchers at the University of California, San Diego (UCSD) have initiated a clinical trial to determine if certain types of mushrooms can help treat early-stage COVID-19. It’s not such an odd idea—the first antibiotic, penicillin, was derived from a mushroom. There are approximately 12,000 known species of mushrooms and the research project will focus on turkey tail and agarikon, both native to old growth North American forests—neither have hallucinogenic properties. In lab studies, agarikon demonstrated strong antiviral activity against resistant strains of tuberculosis and H1NA (swine flu), H5N1 (bird flu), cowpox and herpes viruses. In some assays, agarikon was 10 times more potent against flu viruses than the antiviral drug ribavirin. The study is recruiting 132 volunteers recently diagnosed with COVID-19. It will be conducted at UCSD and UCLA. Gordon Saxe, a preventive and integrative medicine physician who leads the Krupp Center for Integrative Research at UCSD, says, “We think mushrooms may have the ability to reduce the severity of COVID.”

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) announced today that it is progressing to multiple ascending doses after completing the dosing of single ascending doses in a Phase 1 study in healthy adults to evaluate the safety and tolerability of an investigational, novel oral antiviral therapeutic for SARS-CoV-2, the virus that causes COVID-19. This Phase 1 trial is being conducted in the United States. The oral antiviral clinical candidate PF-07321332, a SARS-CoV2-3CL protease inhibitor, has demonstrated potent in vitro anti-viral activity against SARS-CoV-2, as well as activity against other coronaviruses, suggesting potential for use in the treatment of COVID-19 as well as potential use to address future coronavirus threats. “Tackling the COVID-19 pandemic requires both prevention via vaccine and targeted treatment for those who contract the virus. Given the way that SARS-CoV-2 is mutating and the continued global impact of COVID-19, it appears likely that it will be critical to have access to therapeutic options both now and beyond the pandemic,” said Mikael Dolsten, MD, PhD., Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer. “We have designed PF-07321332 as a potential oral therapy that could be prescribed at the first sign of infection, without requiring that patients are hospitalized or in critical care. At the same time, Pfizer’s intravenous antiviral candidate is a potential novel treatment option for hospitalized patients. Together, the two have the potential to create an end to end treatment paradigm that complements vaccination in cases where disease still occurs.” Protease inhibitors bind to a viral enzyme (called a protease), preventing the virus from replicating in the cell. Protease inhibitors have been effective at treating other viral pathogens such as HIV and hepatitis C virus, both alone and in combination with other antivirals. Currently marketed therapeutics that target viral proteases are not generally associated with toxicity and as such, this class of molecules may potentially provide well-tolerated treatments against COVID-19. The Phase 1 trial is a randomized, double-blind, sponsor-open, placebo-controlled, single- and multiple-dose escalation study in healthy adults evaluating the safety, tolerability and pharmacokinetics of PF-07321332. Initiation of this study is supported by preclinical studies that demonstrated the antiviral activity of this potential first-in-class SARS-CoV-2 therapeutic designed specifically to inhibit replication of the SARS-CoV2 virus. The structure of PF-07321332, together with the pre-clinical data, will be shared in a COVID-19 session of the Spring American Chemical Society meeting on April 6. Pfizer is also investigating an intravenously administered investigational protease inhibitor, PF-07304814, which is currently in a Phase 1b multi-dose trial in hospitalized clinical trial participants with COVID-19. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at . In addition, to learn more, please visit us on and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. DISCLOSURE NOTICE: The information contained in this release is as of March 23, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer’s efforts to combat COVID-19, Pfizer’s oral antiviral clinical candidate PF-07321332, a SARS-CoV2-3CL protease inhibitor, and Pfizer’s intravenously administered investigational protease inhibitor, PF-07304814, involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including the in vitro data), including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when any drug applications for any potential indications for PF-07321332 or PF-07304814 may be filed in any jurisdictions; whether and when regulatory authorities in any jurisdictions may approve any applications for PF-07321332 or PF-07304814, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of PF-07321332 or PF-07304814, including development of products or therapies by other companies; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at and .