COVID-19 Drug Research Roundup
The FDA late Friday granted Emergency Use Authorization (EUA) to Moderna’s COVID-19 vaccine mRNA-1273, making it the second vaccine to receive an EUA in the U.S. following Pfizer’s approval last week. An FDA vaccine advisory panel on Thursday voted 20-0, with one abstention, to recommend approval of the EUA.
CSL and the University of Queensland are halting development of UQ-CSL V451 after both organizations found the COVID-19 vaccine candidate interfered with some HIV tests. In July, the candidate was studied in 216 healthy volunteers in a phase 1 study. While the vaccine was safe and generated robust responses toward the virus that causes COVID-19, it also generated antibodies directed toward gp41 protein fragments, which stabilize the vaccine.
CureVac has enrolled its first participant in a 35,000-participant phase 2b/3 clinical trial to study the safety and efficacy of the company’s mRNA COVID-19 vaccine CVnCoV. Participants will be enrolled across Europe and Latin America. In September, CureVac launched phase 2 trials with 690 volunteers in Panama and Peru; results from this trial are expected soon.
Researchers investigating Russia’s Sputnik V COVID-19 vaccine say the candidate is 91.4 percent effective at preventing COVID-19, according to phase 3 trial data. The Gamaleya Research Institute reported that there were 62 documented infections in the placebo arm of this trial vs. 16 in the vaccine group. Also, 20 severe cases were reported in the placebo arm, but none were reported in participants who received Sputnik V. The makers of the Sputnik V vaccine have also submitted a request to Mexican authorities to carry out clinical trials in that country.
Last week, AstraZeneca announced it will launch a trial investigating a double-dose regimen of AZD1222, the company’s COVID-19 vaccine candidate, in combination with Russia’s Sputnik V vaccine. Both vaccines rely on the same adenovirus-based technology.
Israel has launched a 1,000-person phase 2 trial of its COVID-19 vaccine developed by the country’s Institute for Biological Research. Once approved to start, the trial will be conducted over several months in adults. If the vaccine is successful, it will then move to phase 3 testing in 30,000 people in Israel and possibly other countries. In an early-stage trial, there were no significant side effects associated with the vaccine in 80 participants.
Valneva plans to start the first clinical trials of its COVID-19 vaccine candidate Valneva 0OB3 in sites across the UK. The phase 1 and 2 trials will enroll 150 healthy participants across Bristol, Birmingham, Southampton and Newcastle to assess the safety of the vaccine and whether it generates an immune response. Pending success of these two trials, the company will then proceed to a larger 4,000-volunteer study in April 2021. The vaccine could be available by the last quarter of 2021.
Pharmacists across the U.S. have discovered extra doses of Pfizer’s and BioNtech’s mRNA COVID-19 vaccine in vials that were delivered to frontline healthcare workers following the vaccine’s recent Emergency Use Authorization. The FDA has recently granted approval to pharmacists to use the extra vaccine doses, but some are cautious to do so and are instead throwing away the leftover doses. The agency has since issued new guidance on state vaccine providers.
A 12,000-volunteer COVID-19 vaccine trial conducted by Sinopharm has resumed in Peru after the country previously halted the trial due to an adverse event. The pause occurred after a participant in the trial developed neurological symptoms. While the company has not released efficacy data from its late-stage trials, the United Arab Emirates noted the vaccine is 86 percent effective against infection in a 31,000-person trial.
The UK’s adaptive RECOVERY trial has done away with antibiotic azithromycin after finding it isn’t beneficial for hospitalized patients with COVID-19. The phase 3 trial administered the antibiotic therapy to 2,582 patients but found no difference in terms of 28-day mortality between this group and a group of 5,182 patients receiving standard care. The mortality rate in both groups was 19 percent. Azithromycin was not effective for reducing the risk of disease progression to mechanical ventilation or for shortening the length of hospital stay. The RECOVERY trial will continue to evaluate convalescent plasma and Regeneron’s COVID-19 antibody cocktail.
Another late-stage trial of Novartis’ and Incyte’s chemotherapy agent ruxolitinib showed no benefit over standard of care for reducing severe complications in 432 hospitalized patients with COVID-19.
FSD Pharma has randomized its first patient in a phase 2a trial studying FSD201 as a potential treatment for severe COVID-19. The study will enroll up to 352 hospitalized patients with COVID-19 to compare FSD201 to standard of care. FSD Pharma says it expects to conduct the trial across 25 to 30 medical centers in North America.
NorthShore University HealthSystem, in collaboration with Johns Hopkins Medicine, plans to start phase 2 trials that will investigate the efficacy of convalescent plasma in outpatients with COVID-19. A total of 30 U.S. sites will take part in the trials, which are funded by the Department of Defense and the National Institutes of Health.
Last week, AbbVie dosed its first patient in a 24-volunteer phase 1 trial studying Harbour BioMed’s experimental antibody 47D11 as a treatment for COVID-19. Harbour has agreed to an undisclosed, one-time licensing fee from AbbVie that will give the biopharmaceutical giant the rights to worldwide development and commercialization of 47D11. The antibody therapy was discovered last year, and testing shows it can target the conserved region of the SARS-CoV-2 spike protein. The early-stage trial conducted by AbbVie will investigate the safety of the therapy when administered at three different doses. The study has a completion date of May 2021.
The Miami Cancer Institute is conducting a trial that is studying the efficacy of mesenchymal stem cells in critically ill patients with COVID-19-induced respiratory failure. The FDA previously granted single-use emergency approval to the institute to use mesenchymal stem cells in critically ill patients with COVID-19. The therapy helped regenerate damaged lung tissue, and the patients recovered after treatment. The phase 1/2a trial is now enrolling hospitalized patients who are receiving oxygen therapy or ventilation support.
Positive results from HLS Therapeutics’ and Amarin Pharmaceuticals’ CardioLink-9 trial show Vascepa (icosapent ethyl) exhibits anti-inflammatory effects in symptomatic outpatients with COVID-19. The study included 100 outpatients with COVID-19 who had at least one symptom. Patients who received icosapent ethyl had a 25 percent reduction in inflammatory markers and a 52 percent reduction in the total patient-reported symptom outcome prevalence score.
Kintor Pharmaceutical’s Proxalutamide reduced hospitalization and ventilation requirements greater than standard care in 319 participants. Patients in the Proxalutamide arm had a hospitalization rate of only 0.8 percent vs. 27 percent in the control group. No mechanical ventilation usage was observed in the treatment group compared with 9 percent of patients in the control arm. Final clinical trial results will be reported in January.
Under terms of a recent global licensing deal, Novartis is providing Mesoblast an upfront $50 million payment for rights to develop and commercialize Mesoblast’s cell therapy remestemcel-L for the treatment of COVID-19. Mesoblast will be eligible to receive milestone payments and royalties on net sales of the therapy if it is approved. In May, a phase 3 trial was launched to evaluate the efficacy of the treatment that was previously observed in 12 patients in a compassionate use program. The late-stage trial will enroll up to 300 patients.
A phase 2 trial in the U.S. has completed dosing of 40 patients with RedHill Biopharma’s COVID-19 candidate opaganib, which aims to reduce blood clotting in cases of acute respiratory distress — a severe outcome of COVID-19. Top-line data from this trial are expected in late December. Another 270-person phase 2/3 study is investigating the efficacy of opaganib for severe COVID-19 pneumonia. The trial has signed up approximately 60 percent of its target enrollment.
A phase 2/3 trial has been launched in the U.S. to examine the cardioprotective effects of Cardiol Therapeutics’ CardiolRx in hospitalized patients with COVID-19 who have a prior history of or risk factors for heart disease. Worldwide Clinical Trials has been named to conduct the trial, which will enroll 422 hospitalized patients with COVID-19.
EUSA Pharma has enrolled its first patient in a a phase 3 trial examining siltuximab in hospitalized patients with COVID-19 or another respiratory virus resulting in acute respiratory distress syndrome. The study will compare siltuximab with standard of care to see if the drug offers a significant benefit in reducing 28-day mortality.
The National Institutes of Health has recently initiated an observational study to examine the short- and long-term effects of SARS-CoV-2 infection in children. The study, dubbed the Pediatric Research Immune Network on SARS-CoV-2 and MISC-C (PRISM), will also seek to identify the immunologic pathways contributing to varying disease presentations and outcomes. At least 250 children and young adults aged 20 years or younger will be enrolled across 20 sites in the U.S.