COVID-19 Drug Research Roundup

COVID-19 Vaccine:

Russia has announced the start of a phase 3 trial that will test Gamaleya Institute’s Sputnik V COVID-19 vaccine in 40,000 volunteers. The announcement follows the controversial approval earlier this month of the vaccine for use in Russia, despite the lack of rigorous safety and efficacy testing on the candidate. The new month-long phase 3 trial plans to enroll volunteers in Russia, Saudi Arabia, the Philippines, the United Arab Emirates, and possibly Brazil and India.

A phase 2 trial for Novavax’s COVID-19 vaccine candidate NVX-CoV2373 has enrolled its first volunteers. This trial is a continuation of the ongoing phase 1/2 trial the company began in Australia in May. During the initial phase of the trial, NVX-CoV2373 generated neutralizing antibodies in all participants following a single dose. The endpoints in the phase 2 study include safety and immunogenicity in individuals between 18 and 84 years of age. The company plans to recruit up to 1,500 participants across 40 sites in Australia and the U.S. A separate phase 2b trial for the company’s vaccine candidate began last week in South Africa, which is investigating the efficacy of the vaccine in 2,665 healthy patients and the safety and immunogenicity in 240 HIV-positive adults.

VBI Vaccines has selected two single-dose COVID-19 vaccine candidates — VBI-2901 and VBI-2902 — to enter human clinical studies by the end of this year. The decision to choose these candidates was based on preclinical trial data, which showed they produced neutralizing antibodies more than convalescent plasma following a single dose. Earlier this month, VBI was granted a $42 million contract from the Canadian government to support its development of vaccines against COVID-19 through phase 2 testing.

New data from a small, early-stage trial shows that Moderna’s COVID-19 vaccine candidate, mRNA-1273, is safe and capable of producing neutralizing antibodies and T cells in patients aged 56 years and above. Additionally, there were no serious adverse events associated with the vaccine. Moderna has also announced that it expects to complete enrollment of patients in its 30,000-patient phase 3 trial, which will investigate the potential COVID-19 vaccine. Currently, the trial has enrolled more than 15,000 participants. Earlier this month, the company announced it will be able to produce anywhere from 500 million to 1 billion 100 mcg doses of the vaccine each year.

The World Health Organization (WHO) says a total of nine COVID-19 vaccines are under investigation by the organization’s cooperative COVAX facility. The COVAX program, which was established earlier this year, now has 172 nations as contributing partners, all of which are pooling efforts to guarantee equitable access to COVID-19 vaccines across the globe. The WHO chief is urging other nations to participate in COVAX to ensure the organization meets its goal of producing at least 2 billion doses of effective and safe COVID-19 vaccines by the end of 2021.

The GRAd-COV2 COVID-19 vaccine candidate from ReThera has entered phase 1 clinical testing in Italy, and the first healthy participant in this study has been dosed. So far, a total of 90 healthy volunteers between the ages of 18 to 55 years and 65 to 85 years have been enrolled in the trial at two sites in Italy. If the initial phase 1 outcome is favorable, the company plans to initiate an international phase 2/3 trial in countries with high COVID-19 infection rates.

Sinopharm affiliate China National Biotec Group has announced its inactivated COVID-19 vaccine has entered phase 3 trials in Argentina. The announcement follows its June 23 approval for trials in the United Arab Emirates as well as recent approvals for trials in Peru and Morocco.

Regulatory approval has been granted to AstraZeneca to conduct part of a phase 3 study of the company’s COVID-19 vaccine product, AZD1222, in Russia. A total of 150 participants will be treated across four medical facilities. Russia previously agreed that the vaccine candidate, developed in collaboration with Oxford University, could be manufactured at R-Pharm facilities.

The country of Thailand has decided to temporarily halt human trials of COVID-19 vaccines because of limited production capacity at facilities in California and Canada, according to the director of the Chulalongkorn University’s vaccine program.

Johnson & Johnson plans to conduct phase 3 trials for its COVID-19 vaccine in Chile and Peru. These two countries will join Brazil and Columbia, both of which will also enroll trial participants. The study will recruit 60,000 volunteers from the four Latin nations.

Two immunizations with a COVID-19 vaccine developed by Translate Bio and Sanofi have shown to induce immune responses in recent nonhuman trials. Currently, Sanofi is also collaborating with GlaxoSmithKline (GSK) to produce a different COVID-19 candidate that uses recombinant protein technology. Both GSK and Sanofi entered into a $2.1 billion deal under the Trump administration’s Operation Warp Speed initiative to supply an initial 100 million doses of their vaccine.

COVID-19 Therapies:

The first volunteers have been enrolled in AstraZeneca’s phase 1 trial of AZD7442. The potential COVID-19 therapy consists of two monoclonal antibodies that may block SARS-CoV-2 from binding to host cells. The phase 1 trial, conducted in the UK, is assessing the safety, tolerability and pharmacokinetics of the therapy in up to 48 healthy volunteers between the ages of 18 and 55 years.

AstraZeneca has also initiated the UK-funded ARCADIA trial, which is testing AZD1656 in patients with COVID-19 and comorbid diabetes. The pharmaceutical company is supplying the drug and leading the trial. The current plan is to recruit 150 patients over four months.

One of the largest safety studies ever performed on hydroxychloroquine (HCQ) and azithromycin, which was led by the Observational Health Data Sciences and Informatics community, indicates that long-term treatment with the two drugs significantly increases the risk of cardiovascular-related mortality. The study examined deidentified electronic health records and administrative claims data for more than 950,000 patients who took HCQ over a 20-year time period.

The National Institutes of Health (NIH) is planning to study GS-441524, the main metabolite of remdesivir, as a possible treatment for COVID-19. This is in response to letters to the NIH from the advocacy group Public Citizen and the MD Anderson Cancer Center, both of which urged the NIH to investigate the antiviral against the SARS-CoV-2 virus.

Gilead Sciences announced new data from its late-stage trial of remdesivir, showing that a five-day course of the drug helped patients with moderate COVID-19 pneumonia, but researchers noted the finding was of “uncertain clinical importance.” Patients in the 600-participant international trial saw an increased chance of improvement over those on standard care, but the benefit’s clinical significance was unclear, according to the data, which was published in the Journal of the American Medical Association. The five-day course of the antiviral appeared to help patients, but no statistically significant difference was seen between patients on the 10-day remdesivir schedule and participants on standard care.

Celltrion has been given the greenlight from the Korean Ministry of Food and Drug Safety to conduct a phase 1 trial of antiviral antibody treatment candidate CT-P59 in patients with mild symptoms of SARS-CoV-2 infection. The study will evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of the product. Celltrion also plans to provide global pivotal study results by the end of the year from phase 2/3 trials and a phase 3 trial, which will include patients with moderate-to-severe COVID-19. The company has already started a phase 1 trial of CT-P59 in the UK.

A GMP production contract has been initiated for Q BioMed’s MAN-19, a potential treatment for complications associated with COVID-19. The contract was initiated with Q BioMed’s technology partner Mannin Research. A phase 1 trial of MAN-19 is expected to begin enrollment in February. Funding from the Canadian and German governments is partially supporting the accelerated development of the novel therapeutic agent.

The first patient has been enrolled in Partner Therapeutics’ phase 2 trial of its inhaled sargramostim therapy. The study is investigating whether this agent improves clinical outcomes in hospitalized patients with COVID-19 and acute hypoxemia. Investigators will compare standard of care alone with sargramostim plus standard of care in 60 patients. This study is one of two sargramostim trials related to COVID-19 that are funded by a $35 million Department of Defense contract. While the phase 2 study is starting enrollment at the University of Utah Health, the drugmaker plans to enroll patients at additional sites.

The FDA has approved the placebo-controlled phase 2 RESOLUTION trial, conducted by Laurent Pharmaceuticals, to test once-a-day oral LAU-7b as a potential treatment for patients with COVID-19. The estimated enrollment for the trial is 300 participants, and the duration of treatment will be 14 days. The primary patient population will be those who are at risk of lung complications because of their age, underlying conditions or both.