COVID-19 Drug Research Roundup

COVID-19 Vaccines:

Preclinical studies have shown that CureVac’s messenger RNA-based COVID-19 vaccine candidate CVnCoV successfully produces neutralizing antibodies and activates T-cells in hamsters and mice. The vaccine is currently undergoing testing in phase 1 and 2 human clinical trials.

AstraZeneca’s ongoing late-stage trial of COVID-19 vaccine candidate AZD1222 shows the vaccine bolsters the immune response to SARS-CoV-2 in older patients. The findings are similar to those reported in younger adults, suggesting the vaccine could become one of the first approved COVID-19 vaccines for use in adults.

The Canadian government says it will invest nearly $163 million to support and accelerate the development of a COVID-19 vaccine from Medicago, a Quebec City-based biotech company. Canada’s Prime Minister Justin Trudeau has said Medicago will possibly supply up to 76 million doses of its COVID-19 vaccine candidate. The vaccine relies on noninfectious virus-like particles that mimic the novel coronavirus to generate an immune response. Medicago says it will start phase 2 trials of its vaccine in early November, with plans to start phase 3 trials in December. In another statement, the Canadian government has also announced it could pay up to $14 million to Vancouver-based Precision NanoSystems to develop a messenger RNA-based COVID-19 vaccine.

In a recent statement, Novavax says it plans to start a phase 3 clinical trial of its COVID-19 vaccine candidate NVX-CoV2373 in the U.S. by the end of November. The study is funded under the U.S. government’s Operation Warp Speed initiative and will seek to enroll up to 30,000 participants in the U.S. and Mexico. The company says it plans to recruit a diverse group of participants. Also, Novavax plans to enroll patients particularly vulnerable to COVID, including those with comorbidities. A separate phase 3 trial of NVX-CoV2373 has so far enrolled 5,500 volunteers in the UK. Novavax hopes to enroll up to 15,000 adult participants in the UK trial by the end of November. The company expects to have interim data from this UK trial as early as the first quarter of 2021.

Israel started human clinical trials on Nov. 1 to study the Israel Institute for Biological Research’s (IIBR) COVID-19 vaccine BriLife. These trials follow preclinical testing of the vaccine that began in March. The human trial will include 80 volunteers between the ages of 18 and 55. Investigators will monitor these participants for three weeks to see if antibodies against the virus develop. A second phase of the trial, slated for December, will include an expanded cohort of 960 adults. IIBR has so far produced more than 25,000 doses of the vaccine for the first and second phases of these trials. If the trials succeed, a third large-scale 30,000-participant trial of IIBR’s vaccine will start in April or May of 2021.

The Italian government is providing $5.8 million as part of an overall pledge of $11.7 million to support the Coalition of Epidemic Preparedness Innovations (CEPI) and its quest to develop COVID-19 vaccines. The goal of the CEPI is to use this funding, in addition to other grants, to advance at least three COVID-19 vaccine candidates to the licensing stage.

PharmaJet’s needle-free injection system has been chosen to deliver another COVID-19 vaccine, this time in the University of Cambridge’s phase 1 trial of DIOSynVax’s candidate. The trial will test delivery of the vaccine through the skin without the use of needles. DIOSynVax is developing its COVID-19 vaccine using computer modeling to identify the virus’ genetic code in the hopes of producing a vaccine that is specific to developing antibodies against SARS-CoV-2.

Russia has paused vaccination of new volunteers in its COVID-19 trial, says Gamaleya Institute Director Alexander Gintsburg, to concentrate on administering a second dose to current trial participants.

COVID-19 Therapies:

The World Health Organization (WHO) says it will publish new guidance in “three to four weeks” on the use of Gilead Sciences’ remdesivir as a COVID-19 therapy. To form the guidance, the WHO is convening an expert panel to review all available evidence on remdesivir’s efficacy against the novel coronavirus. It’s expected that the new WHO guidance will advise countries to review these data prior to approving remdesivir as a treatment for COVID-19. The WHO’s announcement follows recent news from the organization’s 11,266-patient Solidarity trial, which showed that the antiviral drug had “little or no effect” on hospitalized patients with COVID-19. Despite these findings, the FDA recently approved remdesivir for the treatment of COVID-19 infections.

Evgen Pharma has received the green light to start a late-stage trial in the UK that will study SFX-01, the company’s respiratory therapy, as a treatment for COVID-19. The placebo-controlled study will be led by the University of Dundee and will evaluate the efficacy of SFX-01 for reducing inflammation or preventing acute respiratory distress syndrome in patients with suspected COVID-19. The study is being funded in part by medical research charity LifeArc. Results from the trial are expected sometime in 2021.

Enrollment has been finalized for aTyr Pharma’s phase 2 trial that is investigating ATYR1923, an anti-inflammatory drug, for the treatment of COVID-19. Specifically, the study will examine whether ATYR1923 reduces respiratory inflammation in the lungs of patients with severe COVID-19. The study currently has 32 participants across the U.S. Preliminary data from the trial are expected to be released by the end of 2020.

An independent data and safety monitoring board has found no clinical benefit of Eli Lilly’s investigational monoclonal antibody LY-CoV555 combined with remdesivir in a trial investigating the dual approach for COVID-19. As a result, NIH’s National Institute of Allergy and Infectious Diseases (NIAID) has halted enrollment of the trial. The trial was also halted earlier this month because of a safety concern. The recent decision by NIAID to stop enrollment is not expected to impact Eli Lilly’s application to the FDA for Emergency Use Authorization (EUA) of LY-CoV555 for mild-to-moderate nonhospitalized COVID-19 patients.

Regulators in Italy have approved a randomized phase 1 trial that will study generic osteoporosis drug raloxifene for the treatment of COVID-19. While the drug mimics estrogen to improve bone density, researchers hope raloxifene will also reduce symptoms of COVID-19 and make patients less contagious. They argue that the drug contains constituents capable of blocking the virus. The initial trial will enroll 450 hospitalized and nonhospitalized patients with COVID-19 in Milan. Participants will receive a raloxifene capsule regimen over a seven-day period.

Histogen and Amerimmune have joined forces to evaluate Histogen’s investigational liver disease drug emricasan for the management of mild COVID-19. The phase 1 trial is expected to begin by the end of 2020. San Diego, Calif.-based Histogen will retain ownership of emricasan under the partnership. Fairfax, Va.-based research laboratory Amerimmune will fund the research and lead the development of the drug for the treatment of COVID-19.

Antibody cocktail REGN-COV2 significantly reduced virus levels and need for additional medical visits compared with placebo in outpatients with COVID-19, according to new data from Regeneron’s ongoing phase 2/3 trial. The new trial data include an additional 525 patients, bringing the overall study population to 799 patients. The FDA, which is currently reviewing an EUA submission for low-dose REGN-COV2 as a treatment for adults with mild-to-moderate COVID-19, has received the new data. While the findings are promising, the company says it currently has only enough doses for approximately 50,000 patients.

Aerpio Pharmaceuticals has dosed its first patient with razuprotafib in a U.S. military-funded trial that is investigating the drug candidate in moderate-to-severe COVID-19 patients. Razuprotafib is a first-in-class small molecule inhibitor currently in development as a potential glaucoma therapy. The new study is Aerpio’s second clinical trial in COVID-19 patients and complements the I-SPY COVID-19 trial, which is studying razuprotafib in critically ill COVID-19 patients.

Aurinia Pharmaceuticals has started a single-center, open-label exploratory trial investigating the antiviral effects of voclosporin in kidney transplant recipients with COVID-19. The study is being conducted at the Leiden University Medical Center in the Netherlands and is pitting voclosporin against tacrolimus.

The first patient has been enrolled in the immune modulation domain of REMAP-COVID, a sub-study of REMAP-CAP (Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia). The study is testing Amgen’s apremilast and Eisai’s investigational eritoran as potential treatments for hospitalized COVID-19 patients. Amgen and Eisai are both collaborating with the Global Coalition for Adaptive Research to conduct the multicenter REMAP-CAP, which will also investigate several other treatments for hospitalized COVID-19 patients. The study is being led by and conducted at the University of Pittsburgh Medical Center and will be conducted at more than 20 additional hospitals in the U.S.

Boehringer Ingelheim has started a phase 2 trial that will study a novel first-in-class compound, BI 764198, as a treatment for hospitalized COVID-19 patients with severe respiratory complications. The company says the drug may reduce damage to the lungs and may also decrease the need for ventilator support in severe COVID-19 patients. Enrollment is expected to start immediately. The study will be conducted at approximately 40 sites across eight countries.

Biotech company Equillium has received the go-ahead from the FDA to start a phase 3 trial evaluating itolizumab in hospitalized COVID-19 patients suffering from acute respiratory distress syndrome. The trial will enroll 800 patients in the U.S. and abroad starting in the fourth quarter of 2020 and the company expects to release initial findings in mid-2021.