COVID-19 Drug Research Roundup

COVID-19 Vaccines:

The National Institutes of Health (NIH) is currently developing a weakened strain of SARS-CoV-2 for use in human challenge trials in case they are deemed necessary to fully assess candidate COVID-19 vaccines and treatments. It is also weighing the ethical and technical considerations of a human challenge study model, though it’s prioritizing randomized trials for vaccine candidates. The institute said that the challenge studies would not replace phase 3 trials. The University of Oxford is also working on a weakened virus agent that researchers could potentially use in a challenge study if enrollment is insufficient with the standard trial model.

Novavax, in conjunction with researchers from Johannesburg’s Wits University, has initiated a phase 2b trial of COVID-19 vaccine candidate NVX-CoV2373. The Bill and Melinda Gates Foundation helped fund the trial to a tune of $15 million. In this trial, conducted in South Africa, the investigators will evaluate the candidate’s efficacy in 2,665 healthy volunteers, while safety and immunogenicity outcomes will be assessed in up to 240 patients with HIV. The vaccine candidate was previously shown in a phase 1 Australian trial to produce strong antibody responses without any serious adverse events.

Tuberculosis vaccine product VPM1002 has shown promising efficacy against coronavirus infection in a phase 3 clinical trial conducted in Germany. News surrounding the vaccine indicates that India will be the first country to gain access to VPM1002 as the Serum Institute of India is in talks with the developers, the Max Planck Institute for Infection Biology and Vakzine Projekt Management.

According to interim data from a phase 1 and 2 study out of China, a COVID-19 vaccine from Sinopharm produced antibodies at levels similar to those observed with Moderna’s mRNA-1273, Pfizer’s and BioNTech’s BNT162b1 and AstraZeneca’s AZD1222. The phase 1 and 2 trials tested Sinopharm’s candidate vaccine in 96 and 224 participants, respectively. Currently, the vaccine is being investigated in phase 3 studies in the United Arab Emirates and Bahrain. Sinopharm has also received regulatory approval from the Peruvian government to launch a phase 3 trial of its vaccine candidate in the country.

Pfizer’s and BioNTech’s experimental COVID-19 vaccine BNT162b2 has been chosen for a phase 2/3 efficacy study of 9,000 participants following positive results in a phase 1 trial. The candidate was selected for a late-stage trial over another candidate, BNT162b1, because the former “was associated with less systemic reactogenicity, particularly in older adults,” according to a non-peer-reviewed paper published online by medRxiv. Both candidates led to the production of antibodies that could neutralize the SARS-CoV-2 virus at levels similar to or higher than those of people recovering from infection on their own.

Johnson & Johnson’s Janssen Pharmaceutical is launching a phase 1 COVID-19 vaccine trial in Brazil. The trial will focus on vaccine candidate Ad26.COV2.S and will enroll up to 6,000 participants. This marks the fourth COVID-19 vaccine trial approved in Brazil. The company also expects to start the largest phase 3 trial for a COVID-19 vaccine candidate to date in September if results from early-stage studies support it. The company looks to enroll an estimated 60,000 participants in areas with high COVID-19 activity in a phase 3 placebo study to evaluate the safety and efficacy of its experimental vaccine, Ad26.COV2.S. ClinicalTrials.gov posts its estimated start date as Sept. 5.

Pakistan’s regulatory body has given the greenlight to China’s CanSino Biologics and the Beijing Institute of Biotechnology to conduct the country’s first phase 3 trial of COVID-19 vaccine Ad5-nCoV. The trial is set to begin in September and will recruit 10,000 participants. Additional studies are being planned for the vaccine in Saudi Arabia and Mexico. CanSino has also started a late-stage trial of the Ad5-nCoV vaccine candidate in Russia, which is slated to enroll 625 volunteers across eight centers. This phase 3 trial will investigate the efficacy and safety of the vaccine.

Biotech startup Codagenix has developed a single-dose intranasal vaccine from a live version of the COVID-19 virus and is planning to study its effects in phase 1 human trials. Promising results from a pilot study in hamsters facilitated this new research initiative. Codagenix’s early phase human trials, set to be conducted in the UK, will enroll up to 50 young adult volunteers and will initially study the safety of the vaccine. Only Codagenix and two other companies have developed a COVID-19 vaccine using a live attenuated version of the virus.

A phase 1 trial has shown that two doses of Covaxin, an inactivated version of the COVID-19 virus vaccine developed by Bharat Biotech and the Indian Council of Medical Research, was safe in 375 volunteers. The study, which was conducted across 12 sites in India, reported no adverse events in any of the volunteers who received the vaccine. The phase 1 trial is set to be completed at the end of this month.

COVID-19 Therapies:

Fujifilm has initiated a 90-day clinical trial in the Philippines to study the efficacy of favipiravir, the company’s anti-flu drug, against COVID-19. Up to 100 people between the ages of 18 and 74 years will be initially enrolled in the trial. Supportive care will be provided to the first set of patients, while a second group of trial participants will receive supportive care with favipiravir.

Mount Sinai Health System and Renalytix AI have launched a multicenter trial to test the ability of an artificial intelligence (AI) diagnostic platform to assess the risk of kidney disease progression and kidney failure in patients who have recovered from COVID-19. The AI system — KidneyIntelX — will incorporate blood and urine biomarkers, genetics data and information from electronic health records into machine learning algorithms to generate each patient’s risk score. Additionally, high-performance serologic SARS-CoV-2 testing from Mount Sinai will be used to evaluate antibody levels to COVID-19 over time. The initial findings from this trial are expected to be reported later this year.

A small study conducted at New York City’s Mount Sinai Hospital has found that 83 percent of ventilator-dependent patients with COVID-19 survived after receiving just two infusions of Mesoblast’s remestemcel-L, a mesenchymal stem cells (MSC) therapy. A phase 2/3 randomized, placebo-controlled trial was started in May to further test Mesoblast’s MSC treatment in 300 patients with COVID-19. The company says the trial will end in early fall.

Treatment with famotidine in an observational study was found to reduce mortality and the need for intubation among 83 elderly patients hospitalized with severe COVID-19. Patients who received famotidine, which is marketed in the U.S. by Merck and Johnson & Johnson, also had lower levels of serum markers indicative of severe disease. The drug is currently under investigation in a phase 3 study, which is combining famotidine with hydroxychloroquine or Gilead Sciences’ remdesivir.

Johnson & Johnson launched the Corona Accelerated R&D in Europe (CARE) project, a research consortium currently underway in Europe to research and develop new COVID-19 treatments. Europe’s Innovative Medicines Initiative partially funded the consortium with a $93 million grant. The project already has 37 partners across the U.S., the UK, Europe and China.

Treatment with Vanda Pharmaceuticals’ experimental anti-inflammatory drug tradipitant helped hospitalized patients with COVID-19 and pneumonia improve sooner than patients who received a placebo, according to an interim analysis of a phase 3 trial. The ongoing trial, which is set to enroll 300 participants, found that treatment with tradipitant for 14 days was associated with clinical improvement by day seven. Data from the first 60 enrolled patients, however, found no difference between tradipitant and placebo in terms of mortality and the proportion of patients who experienced clinical improvement.