COVID-19 Drug Research Roundup

Below is a roundup of research activity on COVID-19 vaccines and treatments for the past week. To see last week’s column, click here.

COVID-19 Vaccines:

Moderna has received FDA fast-track designation for its COVID-19 vaccine candidate mRNA-1273, making it the first company to do so for any coronavirus vaccine hopeful. The company is currently finalizing its protocol for a phase 3 study of the vaccine, which is expected to begin in early summer.

Neovii has signed a research agreement with Tel Aviv University to develop a coronavirus vaccine. The candidate vaccine will target the “spike” protein that the virus uses to bind to cell receptors in the human body and could be ready for use within a year or 18 months, the university said.

Novavax will receive up to $384 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) for funding its COVID-19 vaccine candidate, NVX-CoV2373. The funding will help support phase 1 and 2 studies and manufacturing efforts to produce up to 100 million doses by year’s end. The coalition previously contributed $4 million toward the vaccine candidate in March. The company expects to begin phase 1 trials this month in Australia and receive preliminary results in July.

COVID-19 Treatments:

Oxford University has kicked off a trial testing existing drugs as potential preventative COVID-19 treatments in older patients. The trial is using participants aged 50 or older that have symptoms of the disease and will start out assessing whether a week’s course of hydroxychloroquine can reduce symptom severity and help avoid hospital admission. In its second phase, the study will test adding azithromycin.

University of Albany researchers said their trial of hydroxychloroquine in COVID-19 patients, the largest one to date, has shown no benefit for the drug. The trial involved 1,436 coronavirus patients in 25 hospitals and found the drug with or without azithromycin was not associated with lower in-hospital mortality. The study also found that a greater portion of patients taking hydroxychloroquine with azithromycin experienced cardiac arrest than ones taking either drug alone.

The University of Hong Kong published findings from a small phase 2 study showing that a triple antiviral combination may be of benefit to patients with moderate to severe COVID-19. The researchers tested a combination of the HIV antiviral lopinavir-ritonavir, the hepatitis C treatment ribavirin and the multiple sclerosis treatment interferon beta-1, and found that the combination suppressed the virus at day seven, five days earlier than in participants given lopinavir-ritonavir alone.

The Rutgers Institute for Translational Medicine and Science is planning a phase 2 COVID-19 trial of Evelo Biosciences’ investigational anti-inflammatory drug, EDP1815. The study will evaluate if the drug can prevent COVID-19 symptoms from progressing and halt the development of related complications, such as cytokine storm. It will initially enroll 60 patients admitted to the emergency room within 36 hours of testing positive for the virus.

Sorrento Therapeutics and Mount Sinai Health System have teamed up to develop an antibody cocktail that could treat COVID-19. The potential treatment, named COVI-SHIELD, would be taken as often as necessary, with each dose expected to provide antiviral protection for up to two months. The partners anticipate the therapy will be offered as a prophylactic for those returning to work and as a therapeutic to those who have been exposed to the virus.

Acer Therapeutics said it is working with the National Center for Advancing Translational Sciences to develop emetine hydrochloride as a potential COVID-19 treatment. The drugmaker said it is planning to begin a phase 2/3 clinical trial of Q3 2020 that will involve high-risk, symptomatic adult COVID-19 patients who don’t need to be hospitalized.

Glenmark Therapeutics said it’s begun phase 3 clinical trials in India to assess a generic version of the antiviral Avigan (favipiravir) as a potential coronavirus treatment. The study involves more than 10 government and private hospitals and is expected to wrap up by July or August.