COVID-19 Drug Research Roundup

COVID-19 Vaccines:

The Coalition for Epidemic Preparedness Innovations (CEPI) has agreed to invest up to $328 million to help China’s Clover Biopharmaceuticals develop SCB-2019, a COVID-19 vaccine candidate. The CEPI funding will support a global phase 2/3 study and will also finance licensing and distribution. The late-stage study of the vaccine is planned to start before the end of the year and will enroll vulnerable patients, including autoimmune and immunocompromised patients, as well as children and pregnant women.

A phase 1 trial of CureVac’s COVID-19 vaccine candidate CVnCoV shows the vaccine generates immune responses and is generally well-tolerated in healthy volunteers. The early-stage trial included more than 250 healthy patients between the ages of 18 and 60 and studied CVnCoV doses ranging from 2µg to 12µg. According to the company, the positive interim results support the move to assess the highest dose level, 12µg, in a pivotal phase 2b/3 trial. Currently, CureVac’s vaccine is being tested in a phase 2a trial in Peru and Panama.

A COVID-19 vaccine candidate developed jointly by the Chinese Academy of Sciences and Chongqing Zhifei Biological Products has been proven safe and capable of generating immune responses in healthy participants, according to findings from phase 1 and 2 trials.

Symvivo has dosed the first healthy volunteer in the company’s phase 1 clinical trial of oral COVID-19 vaccine candidate bacTRL-Spike. The phase 1 trial is being conducted in Australia with Symvivo’s partner Nucleus Network.

Chile’s health regulators have given AstraZeneca the green light to conduct clinical trials of its COVID-19 vaccine. Previously, Chile reserved 14.4 million doses of the vaccine, and Chile’s president has also said the country should have access to 7.6 million doses through the World Health Organization’s COVAX initiative. The AstraZeneca trial will follow a COVID-19 vaccine trial in Chile by Johnson & Johnson, which is currently under way, as well as another trial by Sinovac.

Anvisa, Brazil’s health regulator, has said Johnson & Johnson’s clinical trial of its COVID-19 vaccine can resume after it was paused in mid-October following an unexplained illness in one participant. The planned 60,000-person phase 3 trial is being conducted in 11 states in Brazil and is expected to enroll up to 7,560 adults.

The first doses of CanSino Biologics’ COVID-19 vaccine have been delivered to Mexico for a late-stage trial. The trial is set to enroll between 10,000 and 15,000 volunteers.

COVID-19 Treatments:

Vancouver-based Algernon Pharmaceuticals plans to conduct a late-stage study to evaluate an orally delivered drug, NP-120 (ifenprodil), as a COVID-19 treatment. The drug was originally developed in the 1990s by Sanofi to treat peripheral circulatory disorders and it is still used in generic form in Japan. Participants in the phase 3 study will receive either standard of care, standard of care plus ifenprodil 60 mg or standard of care plus ifenprodil 120 mg. The researchers hope to determine whether the drug improves blood oxygen levels and reduces mortality, as well as time spent in an intensive care unit.

An interim analysis of data from Novartis’ canakinumab trial shows it failed to meet its primary endpoint, indicating that canakinumab plus standard of care did not demonstrate a significantly greater chance of survival for patients without the need for invasive mechanical ventilation compared with placebo plus standard of care. The trial also did not meet its key secondary endpoint of reducing the COVID-19-related death rate during the four-week period after treatment. The results do not affect any other ongoing trials for canakinumab, the company says, including investigations for the treatment of nonsmall-cell lung cancer.

A data monitoring committee reviewing safety and efficacy data from the UK-based RECOVERY trial evaluating Regeneron’s REGN-COV2 in hospitalized patients has given the trial the go-ahead to continue recruitment of eligible patients to all study arms. Researchers in the trial are also planning to test whether aspirin can reduce the risk of blood clots in COVID-19 patients. More than 2,000 patients will receive a daily 150mg aspirin dose in addition to standard of care to see if the drug improves mortality rates after four weeks compared to standard of care alone.

Eli Lilly has received permission to conduct phase 3 trials of baricitinib in India. The trials will compare the effect of a daily 4mg dose of the drug to placebo on disease progression.