COVID-19 Drug Research Roundup

COVID-19 Vaccines:

The University of Minnesota has published results from its COVID-19 trial of hydroxychloroquine that show the antimalaria drug did not effectively prevent COVID-19 infection. The trial, the first randomized placebo trial to evaluate the drug’s effectiveness in preventing infection in healthy patients following exposure, found that it didn’t prevent development of the virus any better than a placebo.

Moderna will begin a phase 3 trial of its COVID-19 vaccine candidate in July, according to Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). He claimed that while the trial will primarily be conducted at U.S. sites, it will also have international sites. The trial will enroll approximately 30,000 participants and will include elderly patients.

The Trump administration’s Operation Warp Speed has reportedly picked five COVID-19 vaccine candidates that the project will begin evaluating. The vaccines — which are being developed by AstraZeneca, Johnson & Johnson, Merck, Moderna and Pfizer — were selected out of a list of 14.

COVID-19 Treatments:

Eli Lilly has begun dosing patients in the world’s first trial to test a COVID-19 antibody candidate in humans. The phase 1 study is taking place at major medical centers across the U.S., including New York’s NYU Grossman School of Medicine and Los Angeles’ Cedars-Sinai. The investigational treatment, LY-CoV555, is the first to come from the drugmaker’s development partnership with AbCellera.

Gilead Sciences’ phase 3 trial of remdesivir has shown positive results in treating COVID-19 patients with moderate symptoms. The study assessed five-day and 10-day courses of the investigational antiviral plus the standard of care vs. standard of care alone in approximately 600 hospitalized patients. Patients on the five-day schedule were 65 percent more likely to have clinical improvement at day 11 compared to those in the standard of care group, while patients given the 10-day treatment did not see significant improvement over the five-day group, the company said.

The Lancet pulled the results of a hydroxychloroquine study after finding that its authors were unable to conduct an independent and private peer review of the data that supported their analysis. The study had claimed that coronavirus patients on hydroxychloroquine experienced a higher mortality rate and increased heart problems, but its data has been called into serious question after the company that gathered and analyzed the data, Surgisphere, refused to provide a full dataset.

The New England Journal of Medicine has also pulled results from a study of blood pressure medications for treating COVID-19 over the same Surgisphere concerns.

PhaseBio Pharmaceuticals plans to conduct a phase 2 trial of its investigational treatment for pulmonary arterial hypertension in COVID-19 patients. The drug, PB1046, will be evaluated as a treatment for hospitalized patients at high risk for rapid deterioration and acute respiratory distress syndrome (ARDS). The trial will enroll approximately 210 patients at 20 U.S. sites.

Sun Pharma has obtained approval from the Indian government for a clinical trial of nafamostat mesilate as a potential COVID-19 treatment. The company is making both the active pharmaceutical ingredient and the finished product of nafamostat.

Relief Therapeutics and NeuroRx have treated the first patients in their phase 2b/3 trial of RLF-100, a formulation of the synthetic human vasoactive intestinal polypeptide (VIP) Aviptadil, to assess its ability to treat ARDS. The multicenter randomized placebo trial aims to enroll 120 COVID-19 patients with ARDS who require mechanical ventilation.

King’s College London is evaluating a formulation of ibuprofen, Flarin, to gauge its viability in treating ARDS in COVID-19 patients. The London study will enroll approximately 230 hospitalized patients who will either receive standard of care or ibuprofen along with standard of care. It is being conducted with help from London’s Guy’s and St. Thomas’ NHS Foundation Trust and Melbourne, Australia-based drug organization the SEEK Group.

BerGenBio has dosed the first COVID-19 patient in its phase 2 trial of bemcentinib. The study, the first to test a candidate under the UK’s ACCORD platform trial, is evaluating the drug as a potential treatment and plans to enroll 120 hospitalized patients. Half will receive the drug with standard of care, while the other half will only receive standard of care. Topline results are expected to come out this summer.

The World Health Organization has resumed its clinical trial of hydroxychloroquine after freezing enrollment to review concerns about the drug’s safety. The trial is an arm of the organization’s Solidarity trial, which is researching multiple therapies that could potentially serve as COVID-19 treatments.