COVID-19 Drug Research Roundup
Sinovac Biotech has launched a phase 3 trial in Turkey that is investigating COVID-19 vaccine candidate CoronaVac compared with a placebo in 1,300 healthcare workers age 18 to 59. In the second stage of the trial, 12,000 participants from the general population will be enrolled.
A late-stage clinical trial of CanSino Biologics’ COVID-19 vaccine candidate Ad5-nCOV has been launched in Pakistan following approval from the country’s regulators last month. The trial will recruit up to 10,000 participants and it’s expected to produce results within the next four to six months. CanSino is also working on launching phase 3 trials of its candidate in Saudi Arabia and Mexico.
Dr. Reddy’s Laboratories is looking to launch late-stage clinical trials of Russia’s COVID-19 vaccine, Sputnik-V, in India in the next few weeks. The trial will enroll between 1,000 and 2,000 participants. Dr. Reddy’s also agreed to seek local regulatory approvals as well as distribute up 100 million doses of the vaccine in the country.
Indian regulators are mandating that COVID-19 vaccine candidates must meet a 50 percent efficacy threshold before they can be approved, according to new draft guidelines released by India’s Drugs Controller General. The trials must also show that the vaccines generate superior antibody and cellular responses. Drugmakers must also demonstrate more than 30 percent efficacy in their secondary study endpoints.
Johnson & Johnson (J&J) has launched its 60,000-participant phase 3 trial studying Ad26 vector-based vaccine Ad26.COV2.S. The trial uses a single dose of the vaccine candidate in contrast to other vaccine candidates that use a two-dose regimen. J&J says that the single-dose regimen could be capable of vaccinating 1 billion people per year. However, the company still plans to run a second phase 3 trial to examine the efficacy and safety of two doses of its vaccine. J&J hopes to produce enough data in these trials to support an Emergency Use Authorization in early 2021.
Novavax last week launched a phase 3 clinical trial of its COVID-19 vaccine in the UK. The study will evaluate NVX-CoV2373 vs. a placebo in 10,000 participants age 18 to 84. The Maryland-based drugmaker is conducting the trial in partnership with the UK government’s Vaccines Task Force. NVX-CoV2373 entered phase 2 testing in the U.S. and Australia last month following positive results from phase 1 testing. The vaccine is also in stage 2 testing in South Africa. The company did not specify when it expects data from the trial. Novavax is also gearing up for a separate phase 3 trial of the vaccine in the U.S. under its $1.6 billion agreement with Operation Warp Speed. That trial, which is expected to begin soon, plans to enroll 30,000 participants.
In a recent late-stage trial from Roche, treatment with rheumatoid arthritis drug tocilizumab was associated with a reduction in the need for ventilation in hospitalized patients with COVID-19 pneumonia. Approximately 12 percent of tocilizumab-treated patients progressed to mechanical ventilation or death compared with 19 percent of placebo-treated patients. While treatment with tocilizumab did not reduce mortality rates in this study, Roche hopes the new data from this phase 3 trial could help secure approval for the drug as a COVID-19 therapy.
The National Institutes of Health (NIH) has expanded two phase 3 trials of convalescent plasma for the treatment of COVID-19. This follows the recent Emergency Use Authorization granted by the FDA for convalescent plasma in patients with COVID-19. In one of the expanded trials, the NIH will increase the sample size from 500 to 1,000 participants across 50 sites. The other phase 2 trial will increase its enrollment from 300 participants to 1,000 hospitalized patients with COVID-19. The NIH’s COVID-19 Treatment Guidelines Panel has noted there are currently not enough data to support or negate the efficacy of convalescent plasma for COVID-19.
The Korean Ministry of Food and Drug Safety has approved Celltrion Group’s Investigational New Drug application for a phase 2/3 trial of anti-COVID-19 monoclonal antibody therapy CT-P59. Celltrion plans to enroll more than 1,000 patients with mild-to-moderate symptoms of SARS-CoV-2 infection from 12 countries. Pending efficacy and safety results, the company expects to apply for an Emergency Use Authorization for CT-P59. The company has also started an in-human global phase 1 clinical trial that is studying the antibody therapy candidate as a preventative agent against COVID-19.
Tiziana Life Sciences has signed an agreement to investigate nasally administered Foralumab, a fully human anti-CD3 monoclonal antibody, in patients with COVID-19. The study will be conducted in Brazil and will compare Foralumab alone or in combination with oral dexamethasone. Tiziana hopes to have clinical trial data available by the end of this year.
DURECT has dosed the first patient in its randomized, double-blind phase 2 study investigating the use of DUR-928 in hospitalized patients with COVID-19 and comorbid acute liver or kidney injury. The study is expecting to enroll up to 80 patients across multiple U.S. sites who will be randomized to receive either DUR-928 or a placebo. Efficacy, defined in this trial by a composite of survival and freedom from acute organ failure by day 28, as well as safety will be examined over a 60-day follow-up period.
A phase 3 study has shown that treatment with Fujifilm’s favipiravir resulted in a significantly shorter time to symptom resolution in patients with COVID-19 compared with those who received a placebo plus standard treatment. The trial, conducted in Japan where favipiravir is approved for influenza, has found no new safety concerns. Fujifilm says it will conduct a full analysis of the phase 3 study data and seek a COVID-19 indication approval for the drug in October.
A team of research scientists from Applied Biology and Corpometria Institute have received a national IRB approval to study nonsteroidal antiandrogen proxalutamide, a potential prostate cancer therapy, for the treatment of mild-to-moderate COVID-19. The researchers theorize that antiandrogens may play a role in reducing progression of the disease. The study will be conducted in Brazil and will start recruiting volunteers this week.
RedHill Biopharma is close to initiating a phase 2/3 study of opaganib for the treatment of severe COVID-19 pneumonia in hospitalized patients. This announcement follows a recent approval for the study by the Brazilian Health Regulatory Agency. The global study is continuing to enroll patients with COVID-19 who require hospitalization and supplemental oxygen with an enrollment target of 270 patients. So far, the study has been approved in Brazil, the UK, Israel, Italy, Russia and Mexico. Another phase 2 study of opaganib will study the therapy in up to 40 hospitalized patients with COVID-19 who require supplemental oxygen. This trial has already met 75 percent of its enrollment goal.