COVID-19 Drug Research Roundup

COVID-19 Vaccines:

Moderna’s COVID-19 vaccine candidate mRNA-1273 was 94.5% effective at preventing infection, according to interim analysis results from the late-stage COVE trial. The European Medicines Agency has begun a rolling review of mRNA-1273, and Moderna says it will apply to the FDA for Emergency Use Authorization (EUA) in the coming days.

A week before Moderna’s announcement, Pfizer and BioNTech announced that their vaccine candidate demonstrated a 90 percent efficacy rate. However, the companies last week announced that their vaccine prevented 95 percent of COVID-19 cases in the now-completed efficacy portion of their phase 3 trial. No vaccine-related serious safety concerns were reported in this 43,538-person study. The companies filed for an FDA EUA last week.

Johnson & Johnson (J&J) has started the second part of its global phase 3 study evaluating a two-dose regimen of COVID-19 vaccine candidate JNJ-78436735. The study is being conducted with the UK’s National Institute for Health Research. Parts one and two of the late-stage trial will each enroll up to 30,000 participants and will test single and double doses of the vaccine, respectively. The second part of J&J’s global phase 3 trial has recently been approved by Spain’s health regulator; dosing will occur in nine hospitals across Spain. J&J entered into an advance purchase agreement with the European Commission in October to deliver up to 200 million doses of its COVID-19 vaccine with an option to provide an additional 200 million.

According to phase 1/2 trial data published in The Lancet, Sinovac’s COVID-19 vaccine candidate CoronaVac triggered rapid immune responses against SARS-CoV-2 in more than 700 human volunteers. The levels of generated antibodies were lower than those observed in patients who had recovered from the disease. Topline phase 1/2 results in June showed the vaccine safely generated antibodies in more than 90 percent of volunteers. Sinovac is currently running phase 3 trials of its vaccine in Brazil, Indonesia and Turkey. Just last week, Brazil stopped its phase 3 Sinovac trial after a patient death. The hold was lifted after the safety monitoring board determined the death was attributable to suicide.

AstraZeneca’s COVID-19 vaccine candidate AZD1222 delivers similar immune responses in people over 70 years of age as it does in people under 70, according to results of a phase 2 clinical trial. A total of 200 people aged 70 years and older received the vaccine during the trial. The study also suggests the vaccine is better tolerated by seniors, indicating the candidate could be an effective and useful prophylactic approach in the population most vulnerable to COVID-19. Researchers from the University of Oxford expect to release results of their phase 3 trials before Christmas.

Inovio has rolled out the phase 2 portion of its phase 2/3 clinical trial for INO-4800, a COVID-19 vaccine candidate funded by the Department of Defense. This portion of the trial will enroll up to 400 participants in the U.S. Participants will receive two injections of the vaccine 28 days apart.

COVID-19 Therapies:

The first patient with severe COVID-19 has been dosed in a randomized, placebo-controlled trial studying F4 Pharma’s anti-inflammatory therapy FX06. Investigators of this study will evaluate whether FX06 can safely and effectively reduce the extracellular lung-water index and improve respiratory parameters in hospitalized patients receiving mechanical ventilation. The study will be conducted across four intensive care units.

A new retrospective study has been launched by Mallinckrodt to analyze real-world data on the use of INOmax, the company’s nitric gas inhaled therapy, as a possible treatment for patients with COVID-19 and respiratory problems.

Findings from two of AstraZeneca’s phase 2 CALAVI trials show its blood cancer drug acalabrutinib does not reduce COVID-19-related respiratory failure or death in hospitalized patients.

A clinical trial has found that a generic antidepressant drug, fluvoxamine, reduced the risk of respiratory deterioration when given within seven days of COVID-19 symptom onset. The study suggests fluvoxamine, a selective serotonin reuptake inhibitor, could prove useful as a treatment for COVID-19 in its early stages. Fluvoxamine is marketed as Luvox by Jazz Pharmaceuticals.

A phase 2 study showed Synairgen’s inhaled formulation of interferon beta, SNG001, significantly reduced the chance of developing severe COVID-19 or death by 79 percent compared with placebo. The study included 101 hospitalized patients with COVID-19 who were randomly assigned to either SNG001 or placebo once daily for 14 days. The study expanded in September to include an additional 120 patients with confirmed COVID-19 to receive SNG001 at home. Investigators are recruiting patients 65 years of age or over and patients aged 50 or over with a high-risk comorbidity.

A small clinical trial led by Sweden’s Karolinska Institutet found that Eli Lilly’s rheumatoid arthritis drug baricitinib reduced mortality by 71 percent in patients with COVID-19. The FDA has recently issued an Emergency Use Authorization for baricitinib in combination with remdesivir for severe COVID-19 based on findings from the double-blind, placebo-controlled ACTT-2 trial.

Approximately 90 percent of patients with COVID-19 who received TrippBio’s COVID-19 candidate TD213 in a clinical trial had cleared the virus after 14 days. Up to 20 percent of patients cleared the virus by day five, and 40 percent of patients cleared it by day 10.

RedHill Biopharma has announced completion of patient enrollment in its phase 2 study evaluating opaganib as a treatment for hospitalized patients with severe COVID-19 pneumonia. A total of 40 patients from across the U.S. were randomized to receive either opaganib or placebo in addition to standard of care. The company says it expects topline data to be available in the coming weeks. RedHill’s parallel global phase 2/3 study is only 50 percent enrolled, with the company expecting topline data in the first quarter of 2021. This study will enroll 270 patients across 21 clinical sites.

Roche’s rheumatoid arthritis drug Actemra (tocilizumab) reduced mortality and improved outcomes for high-risk COVID-19 patients in a clinical trial by researchers at Imperial College London. The study evaluated the efficacy of Actemra along with other immunosuppressive drugs in COVID-19 patients vs. those who did not receive them. In the 303 participants randomized to receive an immunosuppressor, Actemra showed a 99.75 percent efficacy. The UK researchers also found that AbbVie’s HIV antiviral Kaletra (lopinavir/ritonavir) provided no benefit for critically ill COVID-19 patients.

Russia’s Gamaleya Research Institute has reportedly resumed dosing in a phase 3 trial evaluating its COVID-19 vaccine, Sputnik V, but a Russian government spokesperson denies that the study was ever paused. Six of the 29 trial clinics reportedly had paused enrolling new volunteers, with some reports from October indicating enrollment had been stopped due to supply shortages. The Gamaleya Research Institute has claimed the Sputnik V vaccine showed a 92 percent efficacy rate from 20 confirmed COVID-19 cases. The vaccine, which was approved for emergency use in Russia, has been given to frontline healthcare professionals.