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Top COVID-19 Vaccines, Treatments Moving Forward in Clinical Trials
Pharma companies have launched numerous COVID-19 vaccines and treatments over the past few months. Here are recent updates from clinical trials testing the drugs.
Pharmaceutical companies are continuing to boost their efforts to combat COVID-19. Although cases have greatly declined since the start of the pandemic in mid-March, there are still nearly two million confirmed cases in the US alone today.
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Major companies such as Johnson & Johnson and Moderna have launched clinical trials for potential drugs and vaccines that may help to combat the virus.
Here are some of the lead COVID-19 vaccines and treatments being tested in clinical trials now and in the near future.
Johnson & Johnson Announces Acceleration of its COVID-19 Vaccine Candidate
Johnson & Johnson most recently announced that through its Janssen Pharmaceutical Companies, it has accelerated the initiation of the Phase 1/2 clinical trial of its investigational SARS-CoV-2 vaccine.
The randomized, double-blind clinical trial for the vaccine, Ad26.COV2, will evaluate its safety, reactogenicity, and immunogenicity in 1045 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older.
The study will take place in the US and Belgium and is expected in the second half of July, Johnson & Johnson said.
“Based on the strength of the preclinical data we have seen so far and interactions with the regulatory authorities, we have been able to further accelerate the clinical development of our investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant,” Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer, Johnson & Johnson, said in the announcement.
Johnson & Johnson stated that it is committed to the goal of supplying more than one billion doses of the vaccine globally through the course of 2021.
Moderna Doses First Patients in Phase 2 Study of COVID-19 Vaccine
Last week, Moderna announced that the first participants have been dosed in the company’s Phase 2 study of two promising COVID-19 vaccines that use its mRNA vaccine candidate, mRNA-1273.
Nearly 600 participants will be enrolled in two groups, adults aged 18 years of age and older and adults 55 and older. The study will evaluate the safety, reactogenicity, and immunogenicity of two vaccinations of mRNA-1273.
The groups will individually receive 50 μg or a 100 μg dose of both vaccinations. Experts will follow up with participants 12 months after the second vaccination.
Moderna anticipates collaborating with NIAID to implement the Phase 3 study initiation in July.
AstraZeneca Drug Leads to Clinical Improvement in Hospitalized COVID-19 Patients
AstraZeneca recently announced that its drug, Calquence (acalabrutinib), a Bruton’s tyrosine kinase (BTK) inhibitor, reduced inflammation and improved clinical outcomes in patients with severe COVID-19.
The National Institutes of Health (NIH) and AstraZeneca scientists led the peer-reviewed case series of 19 hospitalized COVID-19 patients with severe hypoxia and inflammation. The results were recently published in Science Immunology.
Calquence is a prescription medicine used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment.
But researchers administered the drug in patients with severe respiratory illness caused but SARS-CoV-2 because evidence suggested that dysregulated BTK-dependent lung macrophage signaling mediates cytokine storm and could play a role in COVID-19 pneumonia.
“The science supporting investigation of the use of Calquence in patients with severe COVID-19 is strong,” said José Baselga, executive vice president, oncology R&D.
"The encouraging preliminary data in this case series has informed the initiation of global phase II trials, notably the CALAVI programme. We look forward to completing recruitment and obtaining data in these trials as soon as possible to further our understanding of what this potential treatment could mean for patients.”
Major UK Drugs Trial Will Test Potential Therapeutics for Patients Hospitalized COVID-19
Oxford-based biopharmaceutical company, Izana Bioscience and Slough-based Celltrion Healthcare UK ,will partner with the Universities of Birmingham and Oxford as part of a major COVID-19 drugs trial, according to a recent press release.
Izana Bioscience will provide Namilumab (IZN-101), a fully human monoclonal antibody to treat rheumatoid arthritis and ankylosing spondylitis, an inflammatory disease. Namilumab targets a ‘cytokine’ called GM-CSF, which is naturally produced by immune cells in the body, but is believed to be a key driver of excessive and dangerous lung inflammation seen in COVID-19 patients, the press release stated.
Celltrion Healthcare introduced the drug, Infliximab (CT-P13), an anti-tumor necrosis factor (TNF) therapy that attaches to a protein involved in inflammation and is currently used as a treatment other inflammatory condition.
Each drug will be measured by the amount of oxygen in the blood, as well as using other severity indicators of the disease, researchers said.
Drugs that show reductions in the amount of oxygen needed by the patient and in other severity measures will be recommended for further testing within large ongoing national trials.
“There has been a tremendous effort to pull together this initiative so rapidly. Emerging evidence is demonstrating a critical role for anti-inflammatory drugs in the cytokine storm associated with severe COVID-19 infection,” Ben Fisher, MD, co-clinical investigator of the CATALYST trial from the University of Birmingham’s Institute of Inflammation and Ageing, said in the press release.
“In the CATALYST study we hope to show with a single dose of these kinds of drugs in hospitalised patients, that we are able to delay or prevent the rapid deterioration into intensive care and requirement for invasive ventilation in this critical patient group.”
