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.
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.”
