COVID-19 Drug Research Roundup
Health Canada has approved Moderna’s COVID-19 vaccine for emergency use in Canadian adults, a decision following the country’s conditional approval of Pfizer/BioNTech’s COVID-19 vaccine on Dec. 9. The Moderna and Pfizer/BioNTech vaccines have both demonstrated 95 percent efficacy in phase 3 trials. Canada purchased an additional 20 million doses of Moderna’s mRNA COVID-19 vaccine in December, which brings the country’s total order amount to 40 million doses.
The European Medicines Agency (EMA) has authorized Pfizer/BioNTech’s two-dose COVID-19 vaccine for wide-scale use across 27 EU member states in people 16 years and older. Vulnerable and at-risk populations, including healthcare and long-term facility workers as well as the elderly, have been prioritized to receive the vaccine on its initial rollout. To date, the EU has secured an order of 200 million doses of Pfizer/BioNTech’s vaccine with an option of 100 million additional doses. An EMA advisory group also plans to issue an opinion on Moderna’s COVID-19 vaccine, which is slated for Jan. 6.
Ocugen and India-based Bharat Biotech are collaborating on Covaxin, an inactivated COVID-19 vaccine candidate, for use in the U.S. The candidate has so far been evaluated in 1,000 participants in phase 1 and 2 studies in India, and these studies show the vaccine features promising immunogenicity and safety. Currently, Covaxin is undergoing rigorous testing in a phase 3 study with 26,000 volunteers. The study is testing the vaccine under a two-dose regimen administered 28 days apart. Ocugen will be responsible for clinical development registration and commercialization of the vaccine in the U.S.
More than 20,000 participants have been enrolled in a global phase 3 trial studying CanSino Biologics’ COVID-19 vaccine candidate Ad5-nCoV. The trial, which plans to enroll up to 40,000 adults, is being conducted in Argentina, Chile, Pakistan, Russia and Mexico.
Novavax’s phase 3 study of its COVID-19 vaccine candidate NVX-CoV2373 recently launched in the U.S. and Mexico. The study plans to enroll up to 30,000 people across 115 sites. Approximately two-thirds of study participants will receive the two-dose shot while the other participants will receive a placebo. The company is also conducting a late-stage trial in the UK, which has enrolled 15,000 patients with COVID-19. Another phase 2b study in South Africa and a phase 1/2 trial in the U.S. and Australia are also investigating the safety, immunogenicity and efficacy of Novavax’s NVX-CoV2373. Novavax previously secured a $1.6 billion contract from Operation Warp Speed for manufacturing and development of 100 million vaccine doses for the U.S. In comparison to the Moderna and Pfizer/BioNTech vaccines, Novavax’s NVX-CoV2373 can be stored at normal refrigeration temperatures, which offers fewer logistical challenges in terms of distribution.
Janssen Pharmaceutical has been given the go-ahead from the FDA to conduct late-stage trials in the Philippines of the company’s COVID-19 vaccine candidate. A vaccine expert panel still needs to determine where the study will be conducted before Janssen can begin enrolling participants.
An early-phase trial of a COVID-19 vaccine has been launched in Iran, making it the first study in the country to test a COVID-19 vaccine developed in the Islamic Republic. The study will administer the two-dose vaccine to 56 volunteers approximately two weeks apart. Iran has reportedly prepurchased 16.8 million COVID-19 vaccine doses from Covax.
Russia has approved COVID-19 vaccine Sputnik V for people 60 years of age and older. The approval was made based on data showing the vaccine was more than 90 percent effective in this population. Sputnik V, developed by the Gamaleya National Research Center, was reportedly not associated with severe allergic reactions during the trials.
The Serum Institute of India (SII) and Dynavax Technologies announced they have dosed the first participants in the first phase of a phase 1/2 trial evaluating SII’s COVID-19 vaccine candidate adjuvanted with CpG 1018. The study is investigating the safety and immunogenicity of the vaccine and will first involve 39 healthy volunteers. The second phase of the study will dose up to 216 participants.
CureVac has launched a phase 3 trial of COVID-19 candidate CVnCoV in healthcare workers at Germany’s University Medical Center Mainz. This study, which will enroll more than 2,500 adult participants, will complement a global phase 2b/3 trial that enrolled more than 35,000 people.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted regulatory approval to Oxford University’s and AstraZeneca’s co-developed COVID-19 vaccine candidate. Approval was based on a detailed review by MHRA scientists and clinicians of clinical trial safety and efficacy data. The two-dose vaccine has been approved for people aged 18 years or older in the UK. AstraZeneca expects to deliver up to 2 million vaccine doses a week, with approximately 40 million doses supplied to the UK by late March. First vaccinations are set to begin in early 2021. Brazil also says it will soon investigate the option of emergency-use approval of AstraZeneca’s vaccine. Also, Germany expects the EU will grant rapid approval of the AstraZeneca COVID-19 vaccine. So far, Germany has administered 78,000 shots from Pfizer/BioNTech’s vaccine, which is the only COVID-19 vaccine that has won EU approval.
China’s Sinopharm says its COVID-19 vaccine is 79.3 percent effective at preventing infection, according to preliminary study data. Despite the promising results, the drugmaker provided few additional details about the vaccine’s efficacy or study design, including how many people were vaccinated and the size of the control group.
Boehringer Ingelheim has launched a phase 1/2a study of its inhaled COVID-19 antibody BI 767551. The antibody drug will be tested in people with mild and severe infections and will also be tested as a prophylactic approach in high-risk individuals who are not yet infected. The antibodies were derived from blood samples of patients who had recovered from COVID-19. The first phase of the study will see the drug administered in a single infusion or a single inhalation. Late-stage confirmatory studies will be performed if the drug is well-tolerated by these participants.
Data from a phase 2 study show Vicore Pharma’s oral COVID-19 treatment C21 was 40 percent effective in reducing the risk of needing supplemental oxygen after seven days of treatment in 106 patients with COVID-19. The efficacy of the oral therapy increased to 57 percent at eight days. Patients who received supplemental oxygen and C21 experienced significant reductions in levels of C-reactive protein, reflecting reductions in inflammation.
A long-acting antibody combination therapy from AstraZeneca is being studied as a potential COVID-19 treatment in two UK clinical trials. The therapy, dubbed AZD7442, is a combination of monoclonal antibodies derived from COVID-19 convalescent patients. Only 10 participants have so far been enrolled in the studies.
The FDA has given the greenlight to Shenyang Tonglian Group to study carrimycin as a treatment of severe COVID-19 in hospitalized patients. The randomized study is set to begin in early January and will be conducted in the U.S., Brazil, Mexico, Philippines, Ukraine, Argentina, Peru, Colombia and India. A total of 300 hospitalized adult patients with COVID-19 will be enrolled and assigned to either carrimycin or a placebo.
Hungary has authorized Eli Lilly’s COVID-19 antibody treatment bamlanivimab. Patients in the country could start receiving the therapy by the second half of January.
The first patient has been recruited in Acticor Biotech’s phase 2 GARDEN trial, which is studying glenzocimab as a treatment of COVID-19-related acute respiratory distress syndrome. The randomized study will enroll a total of 60 participants in Brazil and France.
Aldeyra Therapeutics has launched a phase 2 trial studying a reactive aldehyde species inhibitor called ADX-629 as a potential treatment of COVID-19. The trials will also examine the efficacy of the therapy for atopic asthma and psoriasis. The multicenter, placebo-controlled phase 2 trial will enroll 30 participants who will receive either the active therapy or a placebo twice a day for 28 days.
Positive first results from an exploratory phase 1 study show continuous administration of MedinCell’s Ivermectin in healthy volunteers is safe. There were no significant side effects at doses up to 75 ?g/kg. MedinCell suggests the therapy could be useful for COVID-19, given the increasing publicity surrounding its use in these patients.
Hospitalized patients with COVID-19 who were treated with the Regeneron antibody cocktail of casirivimab and imdevimab had a significantly lower risk of death or need for mechanical ventilation, according to results of a phase 3 program. The antibody cocktail also reduced the time-weighted mean daily viral load through day seven and day 11 in seronegative patients. The therapy was also well-tolerated across high- and low-dose groups.