COVID-19 Drug Research Roundup
Brazil’s Ministry of Health has approved clinical trials for AstraZeneca’s and Oxford University’s COVID-19 vaccine candidate. The studies, which are being run by the Federal University of São Paulo and funded by Brazil’s Lemann Foundation, will first test the vaccine in 2,000 volunteers who have not contracted the virus.
Inovio will begin testing its coronavirus vaccine hopeful in a South Korean phase 1/2 trial, the first trial for a COVID-19 vaccine in the country. The study will evaluate its safety, tolerability and immunogenicity in 40 adults aged 19 to 50, and will later enroll 120 patients between the ages of 19 and 64.
Johnson & Johnson subsidiary Janssen announced that it will initiate its phase 1/2a first-in-human trial of its investigational COVID-19 vaccine sooner than expected. Originally set to begin in September, the drugmaker will instead start the trial in the second half of July. The company cited “the strength of the preclinical data we have seen so far” and its interactions with regulators as the reasons for its accelerated development.
FibroGen has started a phase 2/3 trial in Italy to evaluate a pulmonary fibrosis treatment, pamrevlumab, in severe COVID-19 patients. The study will involve 68 hospitalized patients who will be given either pamrevlumab or standard of care. The company also intends to begin two phase 2 U.S. trials.
A trial of convalescent plasma at Houston Methodist Hospital found that the treatment is safe for critical COVID-19 patients. The study evaluated the treatment in 25 patients with severe or life-threatening infections and found that of them, nine had improved within a week of transfusion. An additional 12 patients improved two weeks after treatment.
AbbVie has teamed up with Harbour BioMed (HBM), Utrecht University (UU) and Erasmus Medical Center (EMU) to develop a COVID-19 monoclonal antibody therapy. The partnership will work to advance the fully human, neutralizing antibody 47D11 discovered by UU, EMC and HBM. The drugmaker will help with preclinical activities while preparing for later-stage preclinical and clinical development work.
Regeneron has started the first clinical trials for its antiviral antibody cocktail designed to both prevent and treat COVID-19. The clinical program will involve four different populations: hospitalized COVID-19 patients, nonhospitalized symptomatic patients, unaffected people in groups at risk of high exposure and uninfected people with close exposure to an infected patient.
Vir Biopharmaceuticals’ CEO George Scangos said the company is gearing up to start its first three COVID-19 monoclonal antibody trials “in very short order.” The trials cover the same indications as Regeneron’s antibody studies.
Eli Lilly and Junshi Biosciences have begun a phase 1 trial of a second neutralizing antibody for COVID-19. The trial led by Junshi in China will evaluate the safety and tolerability of the antibody, JS016, in healthy participants who have not been diagnosed with COVID-19. Eli Lilly also plans to initiate a phase 1 U.S. trial of the antibody soon.
Biopharma company Staidson and contract research organization Pivotal are working together to assess the drugmaker’s investigational monoclonal anti-C5a antibody BDB-001. The two will conduct a European trial of progressive severe COVID-19 patients. Staidson said that multiple trials of the investigative drug in China have shown promising results for treating severe COVID-19 infection.
AstraZeneca has licensed six coronavirus-neutralizing antibodies from Vanderbilt University and said it will take two of the monoclonal antibody candidates into a phase 1 trial “within the next two months.” The trials will evaluate the antibodies as COVID-19 combination therapies.
The UK’s Drug Safety Research Unit (DSRU), a nonprofit that studies the safety of medicines, has published the first benefit-risk analysis for Gilead Sciences’ remdesivir, finding it has a favorable overall profile, although questions still need to be answered about its safety. The data analysis found that the drug provided a faster recovery time and reduced the need for ventilation and supportive oxygen.
The National Institutes of Health (NIH)’s National Cancer Institute’s study evaluating AstraZeneca’s blood cancer treatment Calquence (acalabrutinib) as a COVID-19 treatment found the drug helped severe patients. Over the course of treatment, the medicine improved oxygenation in a majority of patients, and by treatment’s end, eight of 11 patients who had needed supplemental oxygen no longer required it, and four of eight patients on mechanical ventilation were successfully extubated.