COVID-19 Drug Research Roundup

Below is a roundup of research activity on COVID-19 vaccines and treatments for the past two weeks. To see the most recent column, click here.

COVID-19 Vaccines:

The European Medicines Agency has signed a contract with the Netherlands’ Utrecht University to helm a real-world monitoring project of COVID-19 vaccines after they are authorized in the EU. The ACCESS project involves 22 European research centers that will look into data sources, such as insurance or hospital health records, which can be used to monitor COVID-19 vaccines in clinical practice.

Moderna has announced positive results from a phase 1 trial of its coronavirus vaccine candidate, mRNA-1273. All participants produced antibodies to the virus within 15 days of a single dose, the company said. Patients who were given two doses at 100 mcg had levels of antibodies that exceeded those seen in convalescent plasma from recovered patients. Participants on the lower dose of 25 mcg had levels of antibodies equivalent to those seen in convalescent plasma from COVID-19 survivors.

AstraZeneca has received a contract from HHS’ Biomedical Advanced Research and Development Authority (BARDA) worth up to $1.2 billion to support the development and production of the University of Oxford’s COVID-19 vaccine candidate, which it has licensed from the research university.

The University of Oxford has begun enrolling participants for its phase 2/3 COVID-19 vaccine candidate trial. The university said its phase 2 study will involve up to 10,260 adults and children, and will be supported by multiple UK institutions. Researchers will assess immune responses to the vaccine in patients of different ages to see if there is variation.

Merck announced two COVID-19 vaccine development efforts and a partnership to develop a novel antiviral. The pharma giant will acquire the Austrian company Themis BioScience and speed up development of its coronavirus vaccine. It will also partner with the nonprofit International AIDS Vaccine Initiative (IAVI) to develop a candidate that uses the same technology as its ebolavirus vaccine Ervebo. The novel antiviral is being developed separately with Ridgeback Biotherapeutics.

Novavax has begun an Australian phase 1/2 trial of its coronavirus vaccine candidate NVX-CoV2373. The phase 1 trial will evaluate the vaccine’s immunogenicity and safety with and without an adjuvant in 130 healthy participants, while the phase 2 trial is expected to be conducted in multiple countries, including the U.S., to assess immunity, safety and disease reduction in a broader age range. The company expects to have preliminary results for the phase 1 study in July.

CanSino Biologics’ coronavirus vaccine candidate has shown promise in being safe and effective in humans, according to the Chinese company’s preliminary data from a phase 1 trial of 108 healthy adults. Based on those results, CanSino will advance to a phase 2 trial in Wuhan, China, of 500 healthy adults, which will include patients over the age of 60. The company is also working with Vancouver, Canada-based Precision NanoSystems to co-develop a COVID-19 vaccine using messenger RNA lipid nanoparticles.

Canadian biopharma company IMV has selected a COVID-19 vaccine candidate that will enter human trials this summer. The trial is expected to enroll 84 healthy participants. The candidate is fully synthetic, making it potentially eligible for rapid and large-scale manufacturing.

The NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Partnership said it’s working to have vaccine candidates ready for trial by the start of July, with the most promising ones going on to phase 2/3 adaptive trials.

COVID-19 Treatments:

Glenmark Pharmaceuticals will start a phase 3 clinical trial in India to test the efficacy of the antivirals favipiravir and umifenovir in treating COVID-19. The trial will examine if early administration of the drug combo will enhance efficacy in 158 hospitalized patients with moderate COVID-19, who will be randomized to receive either favipiravir with or without umifenovir along with the standard of care. The company did not give a timeframe for trial results.

Gilead Sciences’ antiviral remdesivir has been established as the standard of care for moderate to severe COVID-19 patients, after the NIH confirmed that preliminary trial data for the National Institute of Allergy and Infectious Diseases (NIAID)’s study showed the drug delivered a median recovery time of 11 days compared to 15 on a placebo.

The Mayo Clinic’s trial of convalescent plasma found that the treatment is safe for COVID-19 patients. The study enrolled 8,932 hospitalized patients with severe or life-threatening disease, and data from the first 5,000 patients showed that the incidence of serious adverse events in the first four hours after transfusion was less than 1 percent. After seven days of transfusion, the mortality rate was 14.9 percent.

The NIH is beginning a large phase 2b trial to evaluate hydroxychloroquine in combination with the antibiotic azithromycin for treating COVID-19. The trial, which will enroll approximately 2,000 patients in the U.S. who experience fever, cough and/or shortness of breath, is being conducted to assess whether the combo can prevent hospitalization and death in mild to moderate coronavirus patients.

In addition, the NIH’s ACTIV Partnership has chosen six existing treatment candidates for COVID-19 trials. The treatments, which include immunomodulators and supportive therapies but were not identified by the institute, are expected to be evaluated in trials later this month.

More researchers have found that hydroxychloroquine provided no benefit to COVID-19 patients. The University of Paris-Est’s study involved 181 coronavirus patients with pneumonia that were given either standard of care or hydroxychloroquine with standard of care. They found that taking the anti-malaria drug at 600mg per day did not reduce admissions to intensive care or deaths after 21 days from hospital admission. It also did not increase survival in those without acute respiratory distress syndrome (ARDS).

Stanford Medicine researchers are testing interferon-lambda as a potential treatment for mild coronavirus cases. The trial is evaluating the cytokine in 120 newly diagnosed participants to see whether it can help patients recover without the need for hospitalization.

ChemRar Group’s favipiravir trial has shown early positive results for treating COVID-19. The Russian trial’s early data showed that 60 percent of patients who received the treatment tested negative for the virus after five days. The ongoing trial will include 330 patients in 30 Russian medical centers.

ViralClear has received FDA approval for a phase 2 study of its oral antiviral merimepodib as a potential coronavirus treatment. The trial will assess the drug in hospitalized COVID-19 patients who require supplemental oxygen or are on noninvasive ventilation or high-flow oxygen devices.

Covis Pharma has started a phase 3 trial of its FDA-approved asthma drug Alvesco (ciclesonide) in non-hospitalized COVID-19 patients ages 12 and older. The drugmaker will test the inhaled treatment in 400 patients at multiple sites, with participants receiving either the drug with standard supportive care or a placebo with standard supportive care.

Yale University has launched a clinical trial of ibudilast (MN-166) to evaluate its potential in treating COVID-19 patients with ARDS. The placebo-controlled trial is being conducted in collaboration with MediciNova.

The University of Oxford has begun enrolling participants for its large global COVID-19 trial of hydroxychloroquine and chloroquine. The trial will enroll more than 40,000 healthcare workers from Europe, Africa, Asia and South America. Results are expected by the end of the year.

Octapharma is launching a phase 3 trial of its Octagam 10 percent, immune-globulin solution as a potential COVID-19 treatment for patients with severe disease progression. The placebo-controlled trial will evaluate whether the therapy can help slow or stop respiratory deterioration and will enroll approximately 54 adults at 10 U.S. sites.

The University of California, Irvine (UCI) is launching a phase 2b/3 trial to assess the synthetic human polypeptide aviptadil in COVID-19 patients with ARDS. The trial will enroll up to 30 hospitalized patients at UCI Medical Center who need mechanical ventilation.