Are Antivirals For COVID-19 More Likely to Be Developed and Approved Before a Vaccine

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Jun 18, 2020, 08:30 ET

PALM BEACH, Florida, June 18, 2020 /PRNewswire/ -- Now that confirmed worldwide cases of the global health crisis are continuing to grow, scientists are pushing forward with efforts to develop vaccines and treatments to slow the pandemic and lessen the disease's damage. Scientists around the world are working on potential treatments and vaccines and several companies are working on antiviral drugs, some of which are already in use against other illnesses, to treat people who already have COVID-19. Other companies are working on vaccines that could be used as a preventive measure against the disease. Some of the earliest treatments will likely be drugs that are already approved for other conditions, or have been tested on other viruses. An article in Healthline.com said: "People are looking into whether existing antivirals might work or whether new drugs could be developed to try to tackle the virus," said Dr. Bruce Y. Lee, a professor at the CUNY Graduate School of Public Health & Health Policy. These drugs are still being tested in clinical trials to see if they are effective against COVID-19. This step is needed to make sure the medications are safe for this particular use and what the proper dosage should be. So it could be months before treatments are available that are known to work against COVID-19. It could be even longer for a vaccine. Active healthcare stocks in news today include: BioSig Technologies, Inc. (NASDAQ: BSGM), Moderna, Inc. (NASDAQ: MRNA), Novavax, Inc. (NASDAQ:NVAX), Johnson & Johnson (NYSE: JNJ), AstraZeneca PLC (NYSE: AZN).

But there are still other tools we can use to reduce the damage done by the novel coronavirus. "Even though technological advances allow us to do certain things more quickly," Lee told Healthline, "we still have to rely on social distancing, contact tracing, self-isolation, and other measures." The article continued, saying that: "It can take a decade or more for a new compound to go from initial discovery to the marketplace. Many compounds never even make it that far. That's why many medications being eyed as potential treatments for COVID-19 are drugs that already exist. In a recent review in the British Journal of Pharmacology, scientists from the United Kingdom called for wider screening of existing drugs to see if they might work against the coronavirus.

BioSig Technologies, Inc. (NASDAQ:BSGM) BREAKING NEWS - ViralClear Opens Enrollment with First Patient Dosing in Phase II Human Trial of Anti-Viral MMPD Oral Solution for Treatment of COVID-19 - BioSig Technologies and its subsidiary, ViralClear Pharmaceuticals, Inc., today announced that it has commenced patient enrollment with the dosing of the first patient in its Phase II trial for merimepodib, a broad-spectrum, orally administered anti-viral drug candidate for the treatment of COVID-19 in adult patients. Confirmed trial sites include 3 sites from the Mayo Clinic including Rochester, MN, Jacksonville, FL, Phoenix, AZ and St. David's South Austin Medical Center in Austin, TX and the Atlantic Health System -Overlook Hospital in Summit, NJ and Morristown Medical Center in Morristown, NJ.

The Phase II trial is titled "A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Oral Merimepodib in Combination with Intravenous Remdesivir in Adult Patients With Advanced Coronavirus Disease 2019 (COVID-19)". A description of this clinical trial can be accessed via www.clinicaltrials.gov.

Preclinical in vitro laboratory studies performed by the Galveston National Laboratory at The University of Texas Medical Branch demonstrated that merimepodib, provided in combination with remdesivir, showed reduction in SARS-CoV-2 replication to undetectable levels. Peer reviewed publication of these findings can be found at F1000 Research: https://f1000research.com/articles/9-361 Read more news for BSGM by visiting: https://ir.biosig.com/press-releases

In other healthcare news of note:

AGC Biologics, a global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), has announced this month that it will partner with Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, on large-scale GMP production of a critical component of Novavax' coronavirus vaccine candidate, NVX-CoV2373. AGC Biologics will manufacture Matrix-M™, the adjuvant component of the vaccine, in order to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 is a stable, prefusion protein made using Novavax' proprietary nanoparticle technology. AGC Biologics will optimize process development for scaled-up production of Matrix-M to significantly increase Novavax' capacity to deliver doses in 2020 and 2021.

In an article published on CNBC.com, Recent history suggests a new vaccine entering human clinical trials has about a 1-in-3 chance of getting FDA approval. Stephane Bancel, chief executive of Moderna, pegs the chances of his company's novel coronavirus vaccine at closer to 80% to 90%.

"We know our platform," Bancel said in a recent interview. "It works on MERS, Zika and CMV and so on. When you have the right sequence ... you will get neutralizing antibodies."

Moderna, Inc. (NASDAQ: MRNA), the apparent front-runner in the Covid-19 vaccine race, has shown its vaccine elicits those neutralizing antibodies (so-called because they stop the virus from being able to infect cells) in early human studies — but in just eight people so far.

Johnson & Johnson (NYSE: JNJ) this month announced that through its Janssen Pharmaceutical Companies (Janssen) it has accelerated the initiation of the Phase 1/2a first-in-human clinical trial of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Initially scheduled to begin in September, the trial is now expected to commence in the second half of July.

Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said, "Based on the strength of the preclinical data we have seen so far and interactions with the regulatory authorities, we have been able to further accelerate the clinical development of our investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Simultaneously, we are continuing our efforts to build important global partnerships and invest in our vaccine production technology and manufacturing capabilities. Our goal is to ensure we can deliver a vaccine to the world and protect people everywhere from this pandemic."

In an article published by Fiercepharma.com, AstraZeneca PLC (NYSE: AZN), advancing a COVID-19 vaccine from the University of Oxford, is among global frontrunners in the worldwide hunt for a viable vaccine. Now, the drugmaker's CEO says the vaccine is expected to provide protection for one year.

"We think that it will protect for about a year," AstraZeneca CEO Pascal Soriot said on a Belgian radio station, according to reports.

After that protection runs out, it isn't clear whether recipients would be instructed to get another dose, or another vaccine, or rely on COVID-19 treatments if they're approved. So far, Gilead's remdesivir is the only treatment with an emergency use authorization, but research is underway on many other options. On Tuesday, researchers in the United Kingdom reported that the inexpensive steroid dexamethasone cut deaths by a third for patients on ventilation.

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