COVID-19 Drug Research Roundup

COVID-19 Vaccines:

The Walter Reed Army Institute of Research has picked a lead COVID-19 vaccine candidate out of more than two dozen prototypes and plans to start trials later this year. The institute anticipates patient enrollment will begin for a phase 1 trial next month, with dosing slated to begin in September.

Sinovac released preliminary phase 1/2 data showing that its COVID-19 vaccine candidate induced an immune response. During the phase 2 part of the trial, the vaccine induced neutralizing antibodies in 90 percent of participants two weeks after vaccination. The company will progress into a phase 3 study “in the near future,” it said.

The first human trials have begun for Imperial College London’s government-funded COVID-19 vaccine candidate. Researchers at the university are testing to see if the vaccine is well-tolerated and produces an immune response in 300 healthy patients, who will be given two doses. If trial data proves promising, larger phase 3 trials will be planned for later in the year to test the vaccine’s effectiveness in approximately 6,000 healthy participants.

CureVac has obtained regulatory approval in Germany and Belgium to start a phase 1 clinical trial of its COVID-19 vaccine hopeful. The trial will involve 168 healthy subjects aged 18 to 60, with a mission of determining optimal dose and evaluating the vaccine’s safety and immune profile in humans. The company did not give a timeline for initiation.

Clover Biopharmaceuticals has dosed the first participants in the phase 1 trial of its COVID-19 vaccine candidate, SCB-2019. The randomized, double-blind, placebo-controlled study, which is being conducted in Australia, plans to enroll approximately 150 healthy participants. Multiple dose levels will be evaluated with and without adjuvants provided by GlaxoSmithKline and Dynavax, companies Clover has partnered with on vaccine research.

COVID-19 Treatments:

Eli Lilly has started to enroll patients in its phase 3 trial of the rheumatoid arthritis drug Olumiant (baricitinib), which it is testing in hospitalized COVID-19 patients. The trial is expected to enroll 400 patients, with data from the study projected to arrive in the next few months. Eli Lilly said the study will complement other ongoing COVID-19 trials of the drug, including one being run by the National Institute of Allergy and Infectious Diseases.

The University of Oxford’s RECOVERY trial found that the steroid dexamethasone helped severe COVID-19 patients. The trial compared 2,104 patients that took the drug with 4,321 patients who only received standard care, finding that the steroid reduced deaths by one-third in ventilated patients and by one-fifth in patients only receiving oxygen. Patients that did not need respiratory support did not see any benefit.

Gilead Sciences announced it is planning a phase 2/3 clinical trial of its antiviral drug remdesivir for treating pediatric coronavirus patients. The study will evaluate the antiviral’s safety and efficacy in approximately 50 pediatric patients with moderate to severe infection, including newborns through adolescents. The study will be conducted at more than 30 sites in the U.S. and Europe.

The World Health Organization (WHO) has nixed hydroxychloroquine from its ongoing multiarm Solidarity trial, after evidence from multiple trials suggested the drug did not reduce mortality in hospitalized COVID-19 patients compared to standard of care. The WHO had previously put enrollment temporarily on hold in that study arm, basing its decision on results from a now-retracted study published in The Lancet.

Also, the UK’s Medicines and Healthcare Products Regulatory Authority has suspended recruitment for clinical trials of hydroxychloroquine as a potential treatment for COVID-19 patients. The agency said it encountered disappointing results from two trials that showed no benefit in hospitalized COVID-19 patients given the drug.

Merck and Japanese drugmaker PeptiDream are working together to develop novel peptide therapeutics aimed at neutralizing the SARS-CoV-2 virus. They did not disclose the terms of the development and licensing agreement, but PeptiDream will receive an initial payment and possible additional payments, as well as royalties from future sales.

Exscalate4CoV, a consortium funded by the European Union, has used supercomputing to identify a generic osteoporosis drug as a candidate for treating COVID-19. The consortium, after screening 400,000 molecules for potential efficacy against the virus, found that raloxifene could be viable as a treatment for mildly symptomatic patients because it may be able to delay progression of the disease. The drug demonstrated potential in blocking the virus’ replication in cells, which would hinder progression. The consortium is currently in talks with the European Medicines Agency about advancing clinical trials evaluating raloxifene as a COVID-19 treatment.