Biopharma Update on the Novel Coronavirus: August 31

CV Update_August 31

News information is not all-inclusive and updates will now be published on Mondays, Wednesdays and Fridays. 

 

FDA Actions

On Sunday, U.S. Food and Drug Administration (FDA) Commissioner Stephen Hahn told the Financial Times that he would potentially fast-track a COVID-19 vaccine before clinical trials are done if it was “appropriate.” He claimed politics were not part of that decision, saying “this is going to be a science, medicine, data decision.”

Former FDA Commissioner Scott Gottlieb CBS’s “Face the Nation” criticized the statement on CBS’s “Face the Nation,” noting, “I don’t know what is meant by saying before the Phase III trials are completed. These Phase III trials are event-based trials, meaning that they’re going to start to read out data after a certain amount of events accrue in the clinical trials. And those events are people getting COVID infection. And so as the trials progress, if we start to see lower rates of COVID infection in the active group, the group that receives the vaccine versus the placebo group, the group that hasn’t received the vaccine.”

Expanded EUA for Remdesivir: The FDA broadened the scope of an existing Veklury (remdesivir) EUA. The EUA will now include treatment of all hospitalized suspected or confirmed COVID-19 patients.

Public Meeting to Discuss COVID-19 Vaccines: The FDA announced that a public meeting for the Vaccines and Related Biological Products Advisory Committee will be held to discuss the development, authorization and/or licensure of COVID-19 vaccines. The meeting will take place on Oct. 22, 2020.

Diagnostics Update: To-date the FDA has authorized 226 individual EUAs, which include 182 molecular tests, 40 antibody tests and 4 antigen tests.

 

Testing Therapies, Antivirals and Vaccines

Vir Biotechnology and GlaxoSmithKline dosed the first patient last week in a Phase II/III clinical trial of VIR-7831, a fully human monoclonal antibody against COVID-19. The trial is evaluating therapy as early treatment for COVID-19 patients at high risk of hospitalization.

FSD Pharma submitted an IND for FSD201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) to treat COVID-19. FSD201 is being developed for its anti-inflammatory properties to avoid the cytokine storm linked with acute lung injury in hospitalized COVID-19 patients. The Phase II trial will be run at 25 to 30 sites in North America.

Orpheris, a subsidiary of Ashvattha Therapeutics, enrolled the first patients in its Phase II PRANA clinical trial of OP-101 in severe COVID-19. OP-101 is designed to target and shut down all proinflammatory pathways and restore macrophages toa normal, anti-inflammatory state.

Sinovac Biotech received emergency use approval in China for its COVID-19 vaccine, CoronaVac. Earlier in June, Sinovac reported positive preliminary data in Phase I/II clinical trials.

Researchers in Canada have identified viral inhibitors that could be potential candidates as a treatment for COVID-19. Clinical trials of the drug, GC376, are set to launch. Currently, the drug is used as a treatment for a type of coronavirus in cats.

 

Other Industry News

As reported by CNN, potential problems with a COVID-19 vaccine are logistical. Most likely people will need two doses in which there will be a certain level of effort for distribution.

Researchers have identified the nation’s first COVID-19 patient proven to have been reinfected. The 25-year-old man tested positive in April and then again 48 days later in June.

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