COVID-19 Drug Research Roundup
The FDA last week granted Emergency Use Authorization (EUA) to Johnson & Johnson’s (J&J) single-dose COVID-19 vaccine after the agency’s vaccines advisory committee voted 22-0 in favor of it, finding that its benefits outweighed its risks for people age 18 and older. The EUA follows J&J’s announcement last week that trials of the vaccine showed it strongly protected against severe COVID-19 and fully prevented hospitalization and death, including for viral variants.
The FDA’s advisory committee briefing document said that J&J’s single-dose COVID-19 vaccine is effective and prevents disease-related hospitalization, according to a review of clinical trial data. In the company’s study of under 40,000 people, the J&J shot reduced moderate-to-severe COVID-19 cases by 66.1 percent when considering cases that occurred at least 28 days following vaccination. A total of 193 cases of COVID-19 occurred in the placebo group during this time vs. 66 cases in the vaccine group. There were no deaths in the vaccine group, while seven COVID-19-related deaths were reported in the placebo arm. In South Africa, the J&J shot reduced severe or critical COVID-19 by approximately 81.7 percent, starting at 28 days following vaccination. Overall, the company says the vaccine has shown to be 85 percent effective for preventing severe disease.
A phase 2 study has been launched by GlaxoSmithKline (GSK) and Sanofi to evaluate their co-developed adjuvanted recombinant COVID-19 vaccine candidate. The trial, which has started after a more than two-month delay, plans to enroll 720 adult volunteers. Researchers will first determine the most appropriate antigen dosage for a phase 3 study planned for the second quarter of 2021. The phase 2 study will evaluate the safety, reactogenicity and immunogenicity with the two-dose regimen administered three weeks apart. The study will be conducted across sites in the U.S., Panama and Honduras. In their announcement of the phase 2 trial, GSK and Sanofi say they also have started working on targeting emerging coronavirus variants. Pending findings from the planned phase 3 trial and regulatory approval, the companies expect to have a vaccine rollout occurring in the last quarter of this year.
GSK also reported last week that significantly more hospitalized COVID-19 patients age 70 and older were alive and free of respiratory failure after treatment with its investigational monoclonal antibody otilimab in a phase 2 clinical trial.
Pfizer and BioNTech have begun a trial to assess the safety and immunogenicity of a third dose of their COVID-19 vaccine, BNT162b2, against the coronavirus’ South African mutation and other potential viral variants. Participants will receive the booster shot six months to a year after they receive their two-dose vaccination regimen.
In the meantime, findings from a study published in The Lancet show that a single dose of Pfizer/BioNTech’s COVID-19 vaccine was associated with a 75 percent reduction in COVID-19 infection in 7,214 vaccinated healthcare workers. This reduction was observed between 15 to 28 days following inoculation. Additionally, researchers found that the single-dose vaccine was 85 percent effective for reducing symptomatic cases of infection. The study, which has not yet been peer-reviewed, was conducted in Israel, a country that has reportedly vaccinated around half of its population. In spite of the positive findings, the investigators said in their study results that a longer follow-up period is needed to determine the exact length of time a person is protected from COVID-19 following the single vaccine dose.
A pooled analysis of trials from the UK, Brazil and South Africa shows that the efficacy of AstraZeneca/Oxford’s COVID-19 vaccine may be higher when the two doses are given three months apart. In their study, researchers from the University of Oxford found that the vaccine held a 55.1 percent efficacy rate when administered six weeks apart vs. 81.3 percent efficacy when administered 12 weeks apart. These findings, which reflect those from an AstraZeneca primary analysis of the same trials, support the UK and World Health Organization (WHO) recommendations on vaccine administration timing. So far, AstraZeneca has not filed for Emergency Use Authorization, as its phase 3 trial in the U.S. remains ongoing.
Takeda Pharmaceutical has launched a 200-person, phase 1/2 study in Japan to evaluate a COVID-19 vaccine developed by Novavax. The study has been fully enrolled and includes participants age 20 and older. Takeda, which is also in the process of conducting a trial in Japan of Moderna’s COVID-19 vaccine, says it expects to see results from the Novavax study in the second half of 2021. The Japanese pharmaceutical company also says it plans to produce and supply more than 250 million doses of the vaccine.
AstraZeneca has joined forces with Care Access Research, a decentralized research organization, for a phase 3 trial of the company’s investigational COVID-19 antibody cocktail AZD7442. The study will examine the therapy’s efficacy and safety for postexposure prophylaxis as well as pre-emptive treatment in up to 1,125 adult participants in the U.S. and the UK. Participants will include people living or working in long-term care centers, people who work in industrial and military environments, as well as anyone who has been exposed to the virus. Early test results from late-stage trials have shown that AZD7442 may be effective against two COVID-19 strains from the UK and South Africa. AstraZeneca entered its antibody cocktail into an international phase 3 trial in November and has enrolled 3,000 out of its planned 5,000 participants so far.
The FDA has given the greenlight for Adamis Pharmaceuticals to proceed with a phase 2/3 study of its investigational COVID-19 therapy Tempol (MBM-02), following a safety review of the company’s Investigational New Drug (IND) application. Adamis plans to evaluate the safety and activity of its therapy for preventing COVID-19-related hospitalization when given early in the course of the infection. Researchers will also examine inflammation markers and hospitalization rates among participants who receive Tempol vs. placebo. A total of 60 high-risk participants with comorbidities and early COVID-19 will be enrolled in the phase 2 portion of the study. If the data safety monitoring board finds the therapy safe, the phase 3 portion of the study will begin, with a second interim analysis planned after 150 participants have been enrolled. The company says it plans to seek Emergency Use Authorization if the studies find the therapy safe and effective for preventing hospitalization in patients with COVID-19.
Yale School of Medicine is in the process of launching a randomized trial to study whether a combination therapy comprising anti-inflammatory drug colchicine and cholesterol-lowering medication rosuvastatin can reduce complications in patients with COVID-19. The study will enroll 466 patients across five sites in the Yale New Haven Hospital network. Patients will be randomly assigned to either the combination group with standard of care or standard of care alone. The Yale study is based on previous study findings that show colchicine can potentially reduce the inflammatory response observed with SARS-CoV-2.
The Rambam Medical Health Care Campus and Ziv Medical Center in Israel have launched a phase 2 trial to investigate Constant Therapeutics’ TXA127 as a potential treatment for COVID-19. To date, a total of 21 hospitalized patients with moderate COVID-19 have been enrolled in the 120-person trial. Once fully enrolled, 60 patients will receive TXA127 and 60 patients will be assigned to placebo. A similar 100-person phase 2 study at Columbia University Irving Medical Center and New York-Presbyterian Allen Hospital has been given the go-ahead by the FDA to study TXA127 for COVID-19. Researchers from the Israeli study suggest the trial will be completed within a four-month period.