COVID-19 Drug Research Roundup
Chinese pharmaceutical company Sinopharm Group has announced the launch of a COVID-19 vaccine trial in Brazil, which will be the fourth major COVID-19 vaccine trial performed in that country. Sinopharm plans on seeking regulatory approval for the trial in the next two weeks. Currently, the company’s vaccine candidate is being investigated in 15,000 volunteers in the United Arab Emirates.
According to the Russian Defense Ministry, a COVID-19 vaccine tested in Russia recently demonstrated immunity in all participants who received the drug. This news follows an earlier announcement from Russia’s State Research Centre of Virology and Biotechnology Vektor, which stated that the organization will begin production of a COVID-19 vaccine in November. Once developed and approved, this vaccination will be free of charge in the country.
A study from the Hong Kong Polytechnic University and the Macao University of Science and Technology has shown that a recombinant vaccine which blocks protein receptor-binding domain binding to ACE2, the key enzyme implicated in COVID-19, induced high levels of antibodies in animal models. The study investigators observed no obvious side effects associated with the vaccine.
Kentucky BioProcessing, a subsidiary of British American Tobacco, has begun working on an experimental COVID-19 vaccine using tobacco plants. The company has cloned a portion of COVID-19’s genetic sequence and developed a potential antigen, which was subsequently inserted into tobacco plants for reproduction. Kentucky BioProcessing expects the reproduced purified antigen to enter preclinical testing in the next few weeks.
Novavax’s COVID-19 vaccine candidate NVX-CoV2373 generated strong immune responses in healthy volunteers who received two 5mcg or 25mcg injections of the vaccine, according to preliminary findings from the company’s phase 1 trial. Each participant who received a dose of the candidate in the trial produced neutralizing antibodies, and those who were treated with an adjuvanted vaccine exhibited a T-cell response against COVID-19. Currently, Novavax is waiting to hear from the FDA before the company can begin the second phase of the trial in the U.S. and Australia. Novavax recently received $1.6 billion from the U.S. government’s Operation Warp Speed to make 100 million doses of its vaccine for delivery in 2021.
The National Institutes of Health (NIH) has launched clinical trials to test the utility of monoclonal antibodies for treating mild-to-moderate COVID-19. The four trials conducted by the NIH are part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines program, a public-private collaboration which aims to expedite the production of much-needed drugs and vaccines.
BioNTech and Fosun Pharma have initiated a phase 1 trial in China that will study the mRNA-based COVID-19 vaccine candidate BNT162b1. A total of 144 healthy volunteers in the trial will be treated with either a placebo or two different doses of the vaccine candidate 21 days apart. The companies have stated that 72 participants have already received treatment doses.
Zydus Cadila, a drug company based in India, has stated its COVID-19 vaccine candidate ZyCoV-D was safe and well-tolerated in a phase 1 trial. Animal studies have already demonstrated that the ZyCoV-D produces high levels of neutralizing antibodies against the virus responsible for COVID-19. Now Zydus Cadila is set to launch the phase 2 portion, which will test the candidate’s safety and immunogenicity in more than 1,000 healthy volunteers.
Members of the COVID R&D Alliance — namely AbbVie, Amgen and Takeda Pharmaceutical Co. — have enrolled the first set of patients in the I-SPY COVID Trial (Investigation of Serial Studies to Predict Your COVID Therapeutic Response with Biomarker Integration and Adaptive Learning), which is testing the efficacy of cenicriviroc, apremilast and icatibant against COVID-19 in severely ill and hospitalized patients who require high-flow oxygen.
Eli Lilly’s monoclonal antibody LY-CoV555 is currently being studied in two COVID-19 clinical trials by the NIH. One of the trials is a phase 3 study of 300 hospitalized patients with mild-to-moderate COVID-19 who have been randomized to either receive a placebo or LY-CoV555 in addition to Gilead Sciences’ antiviral remdesivir. A separate phase 2 trial from the NIH is studying whether LY-CoV555 can reduce the duration of COVID-19 symptoms through 28 days and increase the number of patients with undetectable virus. Eli Lilly also began a phase 3 trial of LY-CoV555 to see if the monoclonal antibody can prevent COVID-19 in residents and staff at long-term care centers.
The NIH’s National Institutes of Allergy and Infectious Diseases has launched a phase 3 trial of Gilead Sciences’ remdesivir with Merck’s anti-inflammatory drug Rebif (interferon-beta-1a) for treating hospitalized COVID-19 patients. The trial, which will assess the combination treatment’s impact on recovery time compared to treatment with remdesivir alone, looks to enroll 1,000 patients across 100 sites in the U.S. and overseas. Preliminary results are expected this fall.
In June, Vopec Pharmaceuticals began human clinical trials on an herbal Siddha formulation, Amrta Karuna, for the treatment of COVID-19. Findings from the now-completed trial show that treatment with the herbal formulation was associated with a significant reduction in hospital quarantine compared with treatment with a placebo. Additionally, treatment with Amrta Karuna was associated with significantly reduced C-reactive protein inflammatory levels and reduced lactate dehydrogenase tissue damage levels. Agastiya Biotech is currently conducting confirmatory in vitro studies of the formulation in the U.S.
Aerpio Pharmaceuticals and the U.S. government have reached an agreement to initiate a randomized trial studying the effects of razuprotafib, a selective small molecule inhibitor of vascular endothelial protein tyrosine phosphatase, for the prevention and treatment of moderate-to-severe COVID-19. The Medical Technology Enterprise Consortium will grant up to $5.1 million in funding for the trial, while Aerpio will also back the trial with approximately $2.8 million.
The FDA has greenlighted a phase 3 clinical trial that will test the safety and efficacy of bucillamine for the treatment of mild-to-moderate COVID-19. The approval to proceed with this trial was granted to Revive Therapeutics, which plans to start the phase 3 study in September at up to 10 sites in the U.S.
Algernon Pharmaceuticals has enrolled its first patient in a phase 2b/3 COVID-19 study of NP-120, an NMDA receptor inhibitor. Sites in the U.S., Australia, Romania and the Philippines are currently participating in the trial. Algernon plans on enrolling 150 patients in the phase 2b trial. Once positive preliminary data is achieved, the trial will move into phase 3. The company is working on determining the expected enrollment rate and an expected completion date.
Relief Therapeutics and NeuroRx have been handed FDA approval to begin a phase 2/3 trial of inhaled RLF-100 (aviptadil), a synthetic form of a natural peptide that has been shown to block replication of the virus in lung and immune cells, for preventing respiratory failure in patients with moderate-to-severe coronavirus infections. The first phase of the trial will sign up severe, hospitalized patients who do not have respiratory failure. Should early results prove promising, the trial will broaden to include patients at home with mild-to-moderate COVID-19.