4 potential COVID-19 therapeutics advance in trials

Dr. Pierre Kory discusses data on ivermectin as COVID-19 treatment

Dr. Pierre Kory, a lung and ICU specialist, testified Dec. 8 before a Senate hearing on early treatment for the virus and discussed findings with NewsNOW from FOX.

LOS ANGELES - Enrollment has begun to test additional investigational drugs to fight COVID-19 symptoms, the National Institutes of Health (NIH) announced Friday.

Testing started through the "Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)" program, which prioritizes and speeds up development of promising COVID-19 treatments and vaccines.

The studies will test several new interventions for safety and efficacy:

SNG001, an inhalable beta interferon delivered by nebulizer (Synairgen)
AZD7442, a long-acting monoclonal antibody combination that will be studied as both an infusion and an intramuscular injection (AstraZeneca)
Camostat mesilate, an orally administered serine protease inhibitor that may block SARS-CoV-2, the virus that causes COVID-19, from entering cells (Sagent Pharmaceuticals)

The first volunteer enrolled in the SNG001 sub-study on Feb. 10. The other studies are expected to begin enrolling participants soon. The trial will allow for comparison of multiple interventions with a shared group of placebo recipients.

"To ensure that the trial is being conducted in a safe and effective manner, an independent data and safety monitoring board oversees the trial and periodically reviews the accumulating data," the NIH wrote.

Phase 2 studies in ACTIV-2 enroll up to 220 volunteers, while exact enrollment size of Phase 3 studies will vary depending on mode of administration of the investigational agent.

"If an investigational agent shows promise by demonstrating safety and reducing COVID-19 symptoms through 28 days following administration, the ACTIV-2 trial is designed to expand seamlessly from a Phase 2 to a Phase 3 study to gather additional critical data from a larger pool of volunteers without delay," the news release stated.

On Aug. 4, 2020, NIAID announced the launch of ACTIV-2, which initially tested LY-CoV555, a monoclonal antibody made by Eli Lilly and Company. On Nov. 10, this therapeutic, also known as bamlanivimab was granted Emergency Use Authorization by the U.S. Food and Drug Administration for treating mild-to-moderate COVID-19 in adults and children over 12 years old who are at high risk for progressing to severe COVID-19 and/or hospitalization.

An ACTIV-2 study testing BRII-196 and BRII-198, investigational neutralizing monoclonal antibodies manufactured by Brii Biosciences, was announced by NIAID on Jan. 5, and is continuing to enroll volunteers.

The potential new therapeutics for COVID-19, if approved for use, would join a relatively short list of treatments available to coronavirus patients.

Remdesivir, a treatment which is sold by Gilead Sciences under the brand name Veklury, was granted an emergency use authorization (EUA) by the FDA in May, before being fully approved as a treatment for COVID-19 in October. The FDA approved the Gilead Sciences antiviral drug as a treatment for COVID-19 patients requiring hospitalization.

Remdesivir was the first fully approved treatment in the U.S. for the novel coronavirus.

In November, the FDA also issued an emergency use authorization for two more monoclonal antibody treatments for mild cases of COVID-19, according to a news release. The same dual therapy was used to treat former President Donald Trump when he was diagnosed with COVID-19 in October.

Casirivimab and imdevimab, which are both manufactured by Regeneron Pharmaceuticals Inc., are to be used in conjunction with one another to treat mild to moderate COVID-19 in adults and pediatric patients.

Last month, drugmaker Eli Lilly said its COVID-19 antibody drug could prevent illness among residents and staff of nursing homes and other long-term care locations.

According to the Associated Press, the drugmaker said participants who got the drug had up to a 57% lower risk of getting COVID-19. Among nursing home residents only, there was up to a 80% reduction in risk. U.S. regulators last year allowed emergency use of the treatment for mild or moderate COVID-19 cases that do not require hospitalization.

As of Friday, there had been over 27.4 million cases of COVID-19 recorded in the United States, and the virus had claimed more than 480,000 lives in the U.S., according to data by Johns Hopkins University.