COVID-19 Drug Research Roundup

COVID-19 Vaccines:

After preliminary trial data showed AstraZeneca’s one-and-a-half-dose COVID-19 vaccine candidate produced 90 percent efficacy, the British drugmaker announced it will initiate a new global clinical trial to confirm its efficacy data in a one-and-a-half-dose regimen. The company has said that some participants in its initial phase 3 vaccine trial in the UK and Brazil only received half doses instead of full doses in the first injection, which warrants the additional investigation. AstraZeneca expects it may receive results of its U.S. vaccine trial in late January, which the company would then use to file for an Emergency Use Authorization (EUA).

The Medicines and Healthcare products Regulatory Agency in the UK is conducting a rolling review of the latest efficacy and safety data on Pfizer/BioNTech’s COVID-19 vaccine. The FDA could issue an EUA for the vaccine in just a few weeks, with initial doses being deployed to vulnerable populations as soon as Dec. 11. While the Pfizer/BioNTech COVID-19 vaccine candidate demonstrated 95 percent efficacy in its late-stage trial, temperature-related storage requirements pose significant logistical challenges in its distribution.

BioNTech recently joined forces with Fosun Pharma to begin a phase 2 trial of its mRNA COVID-19 vaccine BNT162b2 in China per an agreement signed by the two companies in March. The trial will evaluate the safety and immunogenicity of the vaccine in 960 healthy participants between the ages of 18 and 85.

Russia’s Sputnik V COVID-19 vaccine, which has drawn criticism and controversary since it landed on the scene earlier this year, is reportedly 95 percent effective. This is according to Russian scientists who have commented on interim data from a study of 22,000 people. Russia says it will sell the vaccine, developed by Gamaleya Research Institute of Epidemiology and Microbiology, for less than $10 per dose. In a recent updated analysis of a phase 3 trial, the Russian Direct Investment Fund announced that the Sputnik V vaccine has an efficacy of 91.4 percent, contradicting reports of 95 percent efficacy. The new data were obtained from a second interim analysis of the trial, which showed eight confirmed cases of COVID-19 in the vaccine group vs. 31 cases in the placebo group.

The Ministry of Food and Drug Safety in South Korea has approved trials studying different COVID-19 vaccine and treatment candidates. The clinical trials approved to start in South Korea include a phase 1 trial of vaccine candidate NBP 2001 from SK Bioscience and a phase 2 trial of drug candidate DW2008 from DongWha Pharm.

Novavax has said it will start a phase 3 trial of NVX-CoV2373, the company’s COVID-19 vaccine, across more than 100 trial sites in the U.S. and Mexico. The company also announced that its late-stage trial of 15,000 participants in the UK is now fully enrolled. Interim data from this trial are expected as early as the first quarter of 2021. The data from the UK trial are expected to provide a basis for licensure application in the UK, in addition to the European Union and other neighboring countries. Also, Novavax has fully enrolled its South Africa phase 2b trial of NVX-CoV2373. The study includes 4,422 volunteers, including 245 medically stable HIV-positive participants.

Moderna has been a leading contender in the global race to receive the first EUA for a COVID-19 vaccine. On Nov. 30, the company submitted an EUA request to the FDA for its COVID-19 vaccine candidate mRNA-1273. This follows promising findings from Moderna’s late-stage clinical trial showing the vaccine was 95 percent effective at preventing infection. The company plans to test the vaccine in up to 3,000 children between the ages of 12 and 17, but no announcements have been made as to when the study will begin recruiting participants.

An investigational vaccine developed by scientists at the City of Hope generated strong protective immunity against SARS-CoV-2, the virus responsible for COVID-19, in a preclinical trial. In the study, researchers found the vaccine produced neutralizing antibodies that prevented the virus from infecting healthy cells. The vaccine is currently undergoing further investigation in a phase 1 trial at City of Hope.

COVID-19 Therapies:

A large clinical trial in Africa organized by the 26-member ANTICOV coalition will investigate several treatments for mild COVID-19 across 13 countries. In the adaptive platform trial, investigators will study treatments currently approved for malaria, HIV, hepatitis C, parasitic infections and different cancers.

Synairgen and Parexel Biotech are collaborating on a phase 3 trial studying SNG001, an inhaled formulation of an interferon-beta therapy, as a potential treatment for hospitalized patients with COVID-19. The randomized controlled trial will enroll 900 patients across 20 countries and will evaluate whether SNG001 accelerates recovery from severe COVID-19 compared with placebo.

A phase 3 clinical trial led by the Mumbai Hospital shows that Glenmark Pharmaceuticals’ antiviral drug favipiravir prevents replication of SARS-CoV-2 in patients with mild-to-moderate COVID-19. The 150-patient study also found that treatment with favipiravir delayed the need for supportive oxygen therapy in these patients. Currently, favipiravir is used in China and India on an emergency basis for COVID-19, and Russia and some countries in Eastern Europe have approved the treatment for the disease. Health Canada and the FDA have approved Canadian firm Appili Therapeutics’ request to conduct a phase 3 trial investigating the use of favipiravir tablets as a post-exposure prophylaxis therapy for COVID-19.

Another study suggests convalescent plasma offers little to no clinical or mortality benefit for patients with COVID-19 and severe pneumonia. The trial, which was conducted at the Hospital Italiano de Buenos Aires in Argentina, found that there was no difference between patients who received convalescent plasma therapy vs. those who received placebo in terms of improving pneumonia or reducing the risk of death.

Allero Therapeutics and Abbreos are jointly working to develop anti-inflammatory drugs for patients with COVID-19 who are at risk of developing acute respiratory distress syndrome. Allero’s OroMucosal ImmunoGlobulin technology will be evaluated in clinical trials in Miami and Flanders, Belgium, in 2021.

A University of Oxford study titled the Platform Randomized Trial of Interventions against Covid-19 In Older People (PRINCIPLE) trial is currently investigating the efficacy of inhaled corticosteroids in treating COVID-19 in people over the age of 50. In addition to inhaled budesonide, other therapies being studied in this trial include doxycycline and azithromycin. So far, the PRINCIPLE trial has enrolled more than 2,100 people across the UK.

The University of New Mexico has enrolled a patient in a clinical trial investigating the safety and tolerability of SBI-101, a novel investigational therapy developed for acute breathing and kidney problems, in the treatment of patients with COVID-19 and acute kidney injury. The University of Mexico is currently listed as the sole trial site for this early-stage phase 1/2 study.

Takeda’s colchicine, an inexpensive anti-inflammatory drug used for gout and other inflammatory conditions, is now being studied as a potential COVID-19 therapy in the UK’s RECOVERY trial. Investigators believe the drug could treat severe COVID-19 in patients requiring mechanical ventilation. The trial will investigate colchicine’s impact on length of hospital stay, supplemental oxygen requirements and mortality at 28 days.

Amgen, Takeda and UCB have enrolled their first patient in the COMMUNITY trial, which is investigating the use of three drugs for reducing the severity of COVID-19 in hospitalized patients. The organizations, all of which are members of the COVID R&D Alliance, will first test Amgen’s PDE4 inhibitor apremilast followed by Takeda’s plasma kallikrein inhibitor lanadelumab and UCB’s investigational C5 inhibitor zilucoplan.

The National Institute of Allergy and Infectious Diseases has started enrolling hospitalized patients with COVID-19 in its fourth iteration of the Adaptive COVID-19 Treatment Trial (ACTT-4). The ACTT-4 is expected to enroll up to 1,500 patients across 100 sites in the U.S. and other countries. Patients will be randomly assigned to either a dexamethasone and remdesivir combination or a remdesivir and baricitinib dual approach. Researchers will look to identify which combination strategy prevents disease progression.