COVID-19 Drug Research Roundup

Below is a roundup of research activity on COVID-19 vaccines and treatments. It is an update of a weekly column that we will be featuring. To see last week’s column, click here.

COVID-19 vaccines:

• Johnson & Johnson has identified a vaccine candidate frontrunner for COVID-19. The drugmaker said it has also ramped up its manufacturing capabilities, including the establishment of U.S. vaccine manufacturing operations, with the goal of supplying more than 1 billion doses of a vaccine globally. J&J said it plans to begin testing the vaccine candidate in humans no later than September.
• Additionally, Johnson & Johnson announced that it has paired up with HHS’ Biomedical Advanced Research and Development Authority on vaccine development efforts. Together, they have contributed more than $1 billion toward novel coronavirus vaccine research, the company said.
• The World Health Organization’s (WHO) Solidarity multi-arm trial has enrolled its first patients in Norway and Spain. WHO said the trial, which is evaluating the safety and effectiveness of four drugs or drug combos against COVID-19, is a “historic trial that will dramatically cut the time needed to generate robust evidence.” The organization predicted a vaccine is still 12 to 18 months away.
• Sanofi and Translate Bio are collaborating on the development of a novel mRNA vaccine candidate for novel coronavirus. Translate Bio will leverage its mRNA research platform to identify and develop vaccine candidates, while Sanofi will lend its support for any hopeful prototypes.
• Scientists with the University of Pittsburgh School of Medicine announced they have developed a potential vaccine for COVID-19. Testing in mice showed that the vaccine creates enough antibodies specific to SARS-CoV-2 to potentially neutralize the virus. The vaccine uses lab-made pieces of viral protein to build immunity the same way current flu shots function. When tested in mice, the vaccine, delivered through a fingertip-sized patch, produces antibodies specific to SARS-CoV-2 at quantities thought to be sufficient for neutralizing the virus.

COVID-19 treatments:

• Sanofi and Regeneron said they have dosed the first patient in their global Phase 2/3 COVID-19 trial of the human monoclonal antibody Kevzara (sarilumab). The clinical program has initiated in Canada, France, Germany, Italy, Russia and Spain, and is enrolling patients. The drug inhibits IL-6, which could help control acute respiratory-distress syndrome caused by severe COVID-19 infection.
• Gilead has announced the initiation of two phase 3 randomized studies in the UK that will look into the safety and efficacy of its antiviral remdesivir in treating moderate to severe COVID-19. The studies, which received the government’s urgent public health research designation, will initially use 15 centers.
• Synairgen has dosed the first patient in its clinical trial of the antiviral SNG001. The phase 2 trial is being held to see if the inhaled formulation of interferon-beta-1a is safe and effective in treating COVID-19. In two phase 2 clinical trials of SNG001 in asthma patients, the drug activated antiviral pathways in the lung and improved lung function in patients with respiratory viral infections.
• Fujifilm is offering to provide its influenza antiviral to interested countries and regulators. The company suggested the drug could potentially have an antiviral effect on the coronavirus. Fujifilm warned that while the drug received Japanese approval in 2014 for treating influenza, it’s never seen market distribution and isn’t available in hospitals or pharmacies.
• Mylan has waived exclusivity rights for its generic version of AbbVie’s HIV antiviral Kaletra (lopinavir/ritonavir) to enable other drugmakers to supply the potential COVID-19 treatment. The generic is tentatively approved by the FDA and would receive 180-day exclusivity after AbbVie’s patents expire in November 2021 and May 2022. Chinese researchers running a trial of lopinavir/ritonavir in hospitalized patients with severe COVID-19 said earlier this month that the data did not show a benefit beyond the standard of care.