COVID-19 Drug Research Roundup
Moderna’s vaccine, mRNA-1273, has joined Pfizer/BioNTech and AstraZeneca vaccines in winning UK approval for emergency use, the Medicines and Healthcare Products Regulatory Agency (MHRA) reports. The vaccine, which was proved to be 95 percent effective and is easier to transport and store than the Pfizer vaccine, was approved in Canada and the U.S. last month. MHRA cleared Moderna’s two-dose, four-week gap regimen after authorizing the other two vaccines, which have a longer gap between administration of doses.
The Indian government has granted emergency-use approval for AstraZeneca’s and Oxford University’s codeveloped COVID-19 vaccine. India’s Serum Institute expects to manufacture up to 300 million doses of the two-dose vaccine, now termed COVID-19 Vaccine AstraZeneca, by July. This should be enough to vaccinate 150 million people but given that India’s population totals nearly 1.4 billion people, more vaccine doses will be required. The COVID-19 Vaccine AstraZeneca likely won’t be approved in the U.S. until early April. AstraZeneca has not yet submitted an Emergency Use Authorization (EUA) application to the FDA but plans to file in late January, following the release of additional trial efficacy data.
India also announced it has granted an EUA to Bharat Biotech’s COVID-19 vaccine Covaxin. This two-dose vaccine entered into a phase 3 trial in mid-November, causing concern among many who say there isn’t yet enough safety and efficacy data to support its recent approval in India.
Chief adviser to the Trump administration’s Operation Warp Speed, Moncef Slaoui, suggests Johnson & Johnson’s single-dose COVID-19 vaccine, Ad26.COV2.S, might be approved in the U.S. in February.
China granted conditional authorization to Sinopharm’s inactivated COVID-19 vaccine after interim data from a phase 3 trial showed the candidate is 79.3 percent effective at preventing infection. The trial also showed the two-dose vaccine was safe and produced high antibodies in response to the virus. Vaccinations will be given freely across the country, starting with senior citizens and people with underlying health conditions. More than 3 million people in China, including healthcare staff and supply chain officials, have already received the vaccine. Sinopharm has yet to communicate specific details of the phase 3 trial, including how many participants were in the interim analysis, the number of patients who were given vaccine vs. placebo and what side effects were reported.
Cadila Health announced it has received approval from the Drugs Controller General of India to launch phase 3 trials of its plasmid DNA COVID-19 vaccine candidate ZyCoV-D. Previous phase 1 and phase 2 trials showed the vaccine was safe, well-tolerated and immunogenic. The phase 3 trial will recruit up to 30,000 volunteers.
Arcturus Therapeutics is in the planning stages of launching a 600-participant phase 2 study of its vaccine candidate ARCT-021. The phase 2 study was given the go-ahead after the FDA reviewed favorable tolerability and immunogenicity data from a phase 1/2 study of the vaccine. The trial, which will be conducted in the U.S., will administer the vaccine to 450 participants, while 150 participants will be assigned a placebo. Researchers will conduct early interim safety and immunogenicity analyses to identify a phase 3 study dose, which will be given in a phase 3 trial sometime in the second quarter of 2021.
Iranian COVID-19 vaccines are currently undergoing testing in clinical trials, according to a recent statement made by the Iranian Society for Immunology and Allergy. The country hopes at least one or two vaccine samples will soon complete clinical trials and receive the necessary authorizations for public rollout.
Top-line results from a RedHill Biopharma phase 2 study show treatment with opaganib was associated with greater improvements compared with placebo in reducing oxygen requirements by day 14 in hospitalized patients with COVID-19 and pneumonia. Up to 52.6 percent of patients who received opaganib did not require oxygen support at 14 days compared with 22.2 percent of patients assigned to placebo. There were no major differences between the two treatment groups in terms of safety, but fewer patients in the opaganib experienced serious adverse events. The investigational agent was studied in a small U.S.-based sample of only 40 patients, warranting larger investigation in randomized trials.
A phase 2 trial led by aTyr Pharma found that 83 percent of patients with COVID-19 and severe respiratory complications recovered in less than a week after receiving the company’s investigational treatment candidate ATYR1923 at an intravenous dose of 3.0 mg/kg. Patients treated with a single dose of the therapy had a median recovery time of 5.5 days. The treatment was also well-tolerated and generally safe at dose levels of 1.0 mg/kg and 3.0 mg/kg. No drug-related serious adverse events were reported.
Scentech, an Israeli startup company, has been given the greenlight to launch a trial of a breath test to detect COVID-19 antibodies in vaccinated people. Shamir (Assaf Harofeh) Medical Center, which is already conducting research on the breath test for detecting the virus, will run the new clinical trial. The study will map biomarkers associated with antibodies of type IgM and IgG and may offer rapid insight into vaccine efficacy.
Exhalation Technology has developed a rapid, point-of-care diagnostic COVID-19 breath test called “CoronaCheck.” In a clinical study, the CoronaCheck detected COVID-19 with 100 percent specificity and 100 percent sensitivity in 62 patients who were either positive or negative for the infection. The breath test was also pitted against an FDA-approved panel of respiratory bacteria and viruses and successfully confirmed all coronavirus variants in the pools with 100 percent accuracy.
A large phase 2/3 clinical trial sponsored by the National Institute of Allergy and Infectious Diseases has been launched to evaluate the effects of two experimental antibodies against mild and moderate COVID-19. The two experimental antibodies, BRII-196 and BRII-198, are manufactured by Brii Biosciences. The treatments will be used in a combination approach in the NIH’s ACTIV-2 trial. Up to 220 participants with mild or moderate COVID-19 will be enrolled in the study, with half of these participants receiving placebo and the other half receiving the dual therapy. An independent data and safety monitoring board will evaluate data at 28 days to determine whether the treatment reduces the duration of symptoms and eliminates the presence of viral RNA. Safety will also be assessed. If the findings are promising, the study will transition to phase 3 and will enroll 622 outpatients. The late-stage trial will look to see if the treatment prevents hospitalization or death at 28 days.
Daewoong Pharmaceutical plans to combine its pancreatitis investigational drug DWJ1248 (Foistar) with Gilead Sciences’ remdesivir in a phase 2 trial to see if the dual-treatment approach is effective against COVID-19.
The ANTICOV consortium is carrying out a clinical trial across 19 sites and 13 countries in Africa to identify potential treatments for COVID-19. Initially, the consortium plans to focus on testing lopinavir/ritonavir and hydroxychloroquine. The trial will add new treatments as evidence for their potential use in mild or moderate COVID-19 cases become available.
A small study from Argentina shows that blood plasma from recovered COVID-19 patients reduces the risk of severe COVID-19 in older adults, but only if the treatment is administered within days of disease onset. In the study, a total of 80 participants received an infusion of this blood plasma. The therapy reduced the risk of developing severe COVID-19 by 48 percent compared with another 80 participants who received placebo. All patients in this trial were 65 years of age or older and had underlying comorbidities that made them more vulnerable to COVID-19.