COVID-19 Drug Research Roundup

COVID-19 Therapies:

Treatment with Roche’s rheumatoid arthritis drug tocilizumab reduced the rate of death by 14 percent in hospitalized patients with COVID-19, according to findings from the 36,100-participant global RECOVERY trial. A total of 2,022 patients in the study were randomized to intravenous tocilizumab, while another 2,094 were randomly assigned to standard of care alone. In the study, the addition of tocilizumab to dexamethasone prevented one death for every 25 patients. Up to 596 patients in the tocilizumab arm died within 28 days compared with 694 patients in the control arm. Based on the findings, the investigators estimated that the treatment combination may reduce deaths in hospitalized patients by up to one-third.

An early-stage phase 1 study out of Tel Aviv Sourasky Medical Center found that 29 out of 30 patients with moderate-to-severe COVID-19 recovered within three to five days following treatment with novel cancer drug EXO-CD24. The endpoint of the study was safety, which included an assessment of adverse events that occurred over a 35-day period. In the study, participants inhaled the exosomes-based EXO-CD24 once per day for five days. The study, which is sponsored by Tel Aviv Sourasky Medical Center, is still currently recruiting to evaluate the therapy’s safety in patients with COVID-19.

The Bill and Melinda Gates Foundation and FastGrants are funneling financing toward a global COVID-19 clinical trial focused on antiparasitic agent ivermectin and selective serotonin reuptake inhibitor fluvoxamine. The study will be part of the adaptive Together COVID-19 Trial and will involve participants from Canada, South Africa and Brazil. Researchers will examine the role of these drugs in preventing progression of COVID-19 in up to 3,200 participants. Initial findings from this trial are expected within as few as two to three months.

The European Commission says the European Union (EU) is launching the HERA Incubator, a new program to study mutations in the novel COVID-19-causing coronavirus SARS-CoV-2. The program will comprise health authorities and laboratories across Europe. In addition, the program will work toward developing specialized tests for new variants, proposing a genomic-sequencing funding package of up to 75 million euros for EU member states. Testing will assess the impact of mutations on both transmissibility and fatality. The commission says it will also think about adapting its regulatory framework to support vaccine approvals with smaller data sets that are submitted in real time.

Adagio Therapeutics has dosed its first participant in a phase 1 trial of its anti-SARS-CoV-2 monoclonal antibody ADG20. The study is evaluating the candidate’s safety, tolerability and pharmacokinetics in healthy adults. The company says it plans to move into global pivotal trials to evaluate ADG20’s ability to treat and prevent COVID-19, but only when enough safety data have been accrued from the phase 1 trial. Preclinical evidence suggests the candidate is effective against emerging SARS-CoV-2 variants. Adagio plans to also study intramuscular and intravenous forms of ADG20 in a future phase 1 study.

Fujifilm’s Avigan (favipiravir), an antiviral agent, provides no significant benefit for reducing mortality in patients with mild or moderate COVID-19, according to a meta-analysis of nine global Avigan trials. The analysis, which has been published as a preprint on medRxiv, found that treatment with Avigan was associated with clinical improvement over seven days if given to patients early on during their hospitalization. Despite the therapy’s lack of benefit on COVID-19-related mortality, the drug is approved for use for COVID-19 in Russia and China. In 2014, Avigan was approved in Japan as an emergency flu treatment. Dr. Reddy’s Laboratories, which purchased the global rights to the therapy last year, halted a COVID-19 clinical trial of the drug in January because of lack of benefit.

Recent findings from the University of Oxford suggest AstraZeneca’s inhaled corticosteroid therapy Pulmicort (budesonide) reduces COVID-19-related hospitalizations by up to 90 percent. In this 28-day study, a total of 148 patients took either 800 micrograms of Pulmicort twice a day or placebo. In addition to driving down hospitalization rates in patients diagnosed with COVID-19, the therapy also reduced time to recovery. Patients who took the corticosteroid also had a faster reduction in symptoms following the 28-day period.

The National Institutes of Health (NIH) is launching a new study to analyze remdesivir in pregnant women who have been prescribed the drug for the treatment of COVID-19. It will be carried out by NIH’s International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) network at 17 sites in the continental U.S. and Puerto Rico.

COVID-19 Vaccines:

Pfizer and BioNTech have reported the first dosing of participants in a global phase 2/3 study of the efficacy of their COVID-19 vaccine in pregnant women. The trial will enroll approximately 4,000 participants in nine countries, including the U.S., the UK, Canada, South Africa and Argentina.

The UK is set to start the world’s first COVID-19 human challenge trial within the next few weeks. The trial will enroll 90 healthy adults between the ages of 18 and 30 years, all of whom will be exposed to SARS-CoV-2 in a controlled environment. Researchers will look to develop a model based on the findings of this small-scale trial to use for other COVID-19 challenge studies. Additionally, the study investigators will work to determine the lowest dose of the virus that causes infection. Ultimately, the researchers hope the challenge model could be used to inform future vaccine efficacy testing and answer scientific questions that are difficult to address in traditional field trials.

AstraZeneca is seeking approval of a next-generation vaccine that targets emerging variants. Work with Oxford University has already begun to modify its current vaccine to fight against new variants. If approved, the company hopes to administer the vaccine to patients by fall 2021. The accelerated development process suggests regulators are likely to accept immunogenicity data obtained from small-scale trials. The AstraZeneca and Oxford vaccine is currently approved in Europe, the UK and other countries. The FDA is currently awaiting results from another study before the shot can be approved in the U.S.

Oxford University also recently announced it has launched a randomized, phase 2 study testing the safety and immunogenicity of the AstraZeneca COVID-19 vaccine in children between the ages of six and 17. The study will recruit 300 volunteers, and 240 of these participants will receive the vaccine. The remaining volunteers will receive a meningitis vaccine that will act as a control. Vaccinations are expected to begin this month.

Janssen has submitted a conditional marketing authorization application to the European Medicines Agency (EMA) for the accelerated assessment of Johnson & Johnson’s one-dose COVID-19 vaccine. According to an EMA announcement about the application, the agency’s human medicines committee could provide an opinion by the middle of March, as long as the vaccine’s efficacy, safety and quality data are sufficient. The EMA has been considering using preclinical and clinical data for the vaccine as they become available under a rolling review, as this can shorten the evaluation time. Quality data, preclinical immunogenicity data and clinical safety data on the vaccine’s modified human-adenovirus vector have already been reviewed by the agency.

Two Canadian researchers are asking governments to delay administering the second dose of the Pfizer COVID-19 vaccine, given recent data suggesting one shot is more than 92 percent effective while the second shot adds little benefit. Currently, the vaccine is authorized to be given 21 days apart. The pair of researchers, who published their rationale on delaying the shot in the New England Journal of Medicine, suggest giving just one dose of the Pfizer vaccine could be helpful for certain countries struggling with low supplies and resources.