COVID-19 Drug Research Roundup
Sinopharm has begun a phase 3 trial of its COVID-19 inactivated vaccine candidate in the United Arab Emirates. The study, which dosed its first group of volunteers last week, is the world’s first phase 3 trial for an inactivated vaccine, according to Abu Dhabi’s health department. The trial is approved to enroll up to 15,000 participants, and at least 5,000 patients between age 18 and 60 are expected to be recruited in its first stage.
Moderna will begin enrolling participants for its phase 3 COVID-19 experimental vaccine trial on July 27. The 30,000-participant study is supported by phase 1 study results that showed all 45 participants generated neutralizing antibodies following vaccination with mRNA-1273, the company’s candidate. The results showed the vaccine was generally safe and well-tolerated by participants.
Johnson & Johnson has said that it will start the first phase 1 study for its COVID-19 vaccine candidate, Ad26.COV2-S, which uses recombinant DNA technology, in Belgium on Wednesday. The human trial is anticipated to begin in the U.S. next week and will enroll more than 1,000 healthy adults between age 18 and 55 in addition to patients age 65 and older.
The Chinese government has approved a phase 1 trial of BioNTech’s and Pfizer’s COVID-19 vaccine candidate BNT162b1, BioNTech’s Chinese partner, Fosun Pharma, has announced.
Canada’s Medicago has begun dosing the first participants in a phase 1 trial of its plant-derived COVID-19 vaccine candidate. The trial will evaluate the vaccine in 180 healthy male and female subjects between age 18 and 55 at three different dosage levels of the vaccine, either alone or with adjuvants from GlaxoSmithKline and Dynavax.
Australia’s University of Queensland has dosed the first volunteers in a phase 1 trial of its COVID-19 vaccine candidate. The study will evaluate about 120 volunteers between age 18 and 55, with a number of patients to be given a placebo. Preliminary results are expected in about three months.
Russia’s Sechenov University has completed the first clinical trial of a COVID-19 vaccine candidate. The vaccine, which was developed by the Gamaleya Institute in Russia, was proven safe in 38 healthy patients, according to the researchers.
Indian drugmaker Biocon’s randomized, controlled, open-label COVID-19 study of itolizumab demonstrated that the monoclonal antibody significantly reduced mortality in hospitalized patients. The trial enrolled 30 patients with moderate to severe acute respiratory distress syndrome (ARDS).
Shanghai-based Junshi Biosciences has finished enrolling participants in a phase 1 trial of JS016, its COVID-19 neutralizing antibody. The randomized, double-blind, placebo-controlled study is evaluating the intravenous injection of JS016 in 40 healthy subjects. The candidate is the first COVID-19 neutralizing antibody to enter trials in China.
Keck Medicine of the University of Southern California has begun enrolling patients in an international phase 3 trial evaluating the safety and efficacy of its antiviral candidate, DAS181, as a COVID-19 treatment. More than 30 sites across the U.S., Australia, South Korea and Taiwan are taking part in the trial.
Results published from the University of Oxford’s RECOVERY trial show that the antimalarial drug hydroxychloroquine increased participants’ time in hospital and their risk of progressing to mechanical ventilation or death and did not lower 28-day mortality. The results showed that of the 1,561 patients who received the drug, 26.8 percent died within 28 days of starting treatment compared to 25 percent of participants receiving standard care. The study also found that patients on hydroxychloroquine had to wait longer for hospital discharge than patients not given the drug and were less likely to survive after 28 days.
PhaseBio Pharmaceuticals has dosed the first of more than 200 patients in the phase 2 VANGARD trial of its PB1046 treatment for hospitalized COVID-19 patients at high risk of clinical deterioration and ARDS. PB1046 is a once-weekly subcutaneously injected anti-inflammatory drug.
Korean firm Celltrion has launched a phase 1 study of its antiviral antibody treatment and plans to complete the trial by the third quarter. In addition, Celltrion plans to conduct phase 1 trials at sites across Europe and in the UK. The company plans to follow that study with global phase 2/3 trials, with preliminary results due by the end of the year.
Tetra Bio-Pharma, a developer of cannabinoid-derived drugs, says the FDA has responded positively to its Pre-Investigational New Drug application, which the Canadian company submitted under the agency’s Coronavirus Treatment Acceleration Program. Tetra’s candidate, ARDS-003, is designed to dampen the cytokine release syndrome and prevent the development of ARDS.