COVID-19 Drug Research Roundup

COVID-19 Vaccines:

The University of Oxford has gained approval to conduct a phase 3 trial of its promising COVID-19 vaccine candidate in Brazil. The trial will enroll 5,000 volunteers across the country and administer vaccinations in Sao Paulo, Rio de Janeiro and a site in northeastern Brazil. The vaccine is currently being evaluated in the UK in a phase 2/3 trial that has enrolled more than 4,000 participants and anticipates 10,000 more, as well as a phase 1/2 South African study.

Sinovac has been given the OK by Brazil’s Health Regulatory Agency to initiate phase 3 trials of its coronavirus vaccine candidate CoronaVac. The Chinese company plans to begin enrolling participants this month and expects to study the candidate in 9,000 healthcare professionals across 12 clinical sites.

Pfizer and BioNTech announced positive early results from a phase 1/2 study of their main COVID-19 vaccine candidate, BNT162b1, in the U.S. The study evaluated the safety and immunogenicity of the vaccine in 45 healthy adults aged 18 to 55. They expect to kick off a phase 2b/3 trial of the candidate later in the month.

A COVID-19 vaccine being developed by China’s People’s Liberation Army and two Chinese biotech companies has been approved for phase 1 trials.

Vaxart’s COVID-19 vaccine candidate has been chosen for a nonhuman primate challenge study funded by the Trump administration’s Operation Warp Speed. The California-based company’s vaccine hopeful is administered by tablet rather than injection.

Bharat Biotech has been given the go-ahead by the Indian government to begin clinical trials of its COVID-19 vaccine candidate. The trial will be the first for a COVID-19 vaccine developed in the country. The candidate, Covaxin, is derived from an inactivated strain of the virus that was isolated at India’s National Institute of Virology.

Meissa Vaccines has started preclinical studies for its COVID-19 vaccine candidate. The candidate, MV-014-210 is a live attenuated vaccine. The company said it expects to begin clinical trials of the vaccine early next year.

COVID-19 Treatments:

Regeneron has begun a U.S. phase 3 trial of its antibody cocktail REGN-COV2 assessing its effectiveness in treating and preventing COVID-19. The study, which is being run with help from the National Institutes for Allergy and Infectious Diseases (NIAID), plans to enroll 2,000 patients across 100 sites. The drugmaker has also launched two phase 2/3 trials that are researching how the cocktail fares in treating already-infected patients.

Gilead Sciences released data last week that shows their antiviral remdesivir reduced the risk of mortality for severe COVID-19 patients in a phase 3 trial by 62 percent. The company also has begun a phase 1a trial of its inhaled formulation of remdesivir as a potential outpatient COVID-19 treatment just two weeks after receiving the FDA’s blessing. The randomized, placebo-controlled U.S. trial plans to enroll 60 healthy individuals aged 18 to 45.

Meanwhile, Australia’s Therapeutic Goods Administration (TGA) has granted remdesivir a conditional approval good for up to six years to treat hospitalized COVID-19 patients who are severely sick and require oxygen or high-level support to breathe. The agency granted the approval within two weeks of receiving Gilead’s submission.

Gilead can apply to TGA for full approval once it has additional data confirming remdesivir’s safety and efficacy.

Dublin’s Royal College of Surgeons in Ireland has begun a double-blind placebo-controlled trial of alpha-1-antitrypsin, a naturally occurring protein found in the liver, to study its potential as a therapy for severe COVID-19 patients in intensive care. The trial is the first to be approved in Ireland for testing an investigational drug as a potential COVID-19 treatment.

The University of Oxford has resumed recruitment for its international hydroxychloroquine and chloroquine trial. It had previously been put on hold after a now-retracted study found the anti-malarials had no benefit for treating COVID-19. Nicholas White, a co-principal investigator of the study, said the drugs still need to be researched to see if they can effectively prevent COVID-19 infections. The UK arm of the university’s COPCOV trial has started recruiting again, and new sites are being set up in Thailand, Southeast Asia, Africa and South America.

The World Health Organization has ended the hydroxychloroquine and lopinavir/ritonavir arms of its multinational Solidarity trial. The WHO found the antivirals offered little to no reduction in mortality rates for hospitalized COVID-19 patients and also identified adverse events associated with the drugs that will be reviewed.

Copenhagen’s Union Therapeutics has obtained approval from the Danish drug agency to study an optimized salt form of niclosamide, a tapeworm infection med, as a potential COVID-19 treatment. It will conduct its first human study of the drug at Bispebjerg and Frederiksberg Hospital.

Abivax has dosed the first patient in its French phase 2b/3 study of ABX464, its novel small molecule drug candidate, as a potential COVID-19 treatment. The randomized, double-blind placebo study is evaluating the effects of the drug when taken early in 1,034 elderly or high-risk patients infected with the virus. The company said the study has also been approved by Brazil, Germany, Italy and the UK’s regulators and expects go-aheads in Spain and other Latin American countries.

Ridgeback Therapeutics has begun enrolling patients in a phase 2 trial of its COVID-19 treatment candidate EIDD-2801. The study will assess the oral antiviral’s effectiveness in treating the coronavirus and will be conducted using a new COVID-19 drug testing platform, AGILE, which was developed by the University of Liverpool, Liverpool School of Tropical Medicine and the Southampton Clinical Trials unit.

Sanofi and Regeneron have stopped a phase 3 U.S. trial of their rheumatoid arthritis drug Kevzara (sarilumab) as a COVID-19 treatment after it missed its primary endpoints.

EUSA Pharma is initiating a phase 3 trial of its interleukin (IL)-6 antibody siltuximab for the treatment of hospitalized COVID-19 patients with acute respiratory distress syndrome. The trial will enroll 400 participants that will either receive the drug or a placebo in addition to standard of care and will look to see if they experience improvements in lung function, length of hospital stays and all-cause mortality.

Biophytis is ready to begin a phase 2/3 U.S. trial of its investigational drug Sarconeos for treating COVID-19-associated acute respiratory failure. The trial will initially assess safety and efficacy in 50 hospitalized patients, while its second phase will evaluate efficacy in an additional 300 patients.