COVID-19 Update

COVID-19 Drug Research Roundup

COVID-19 Vaccines:

Moderna has begun a long-awaited phase 3 trial of its COVID-19 vaccine, marking the first phase 3 trial of an experimental COVID-19 vaccine in the U.S. The massive study will enroll 30,000 participants at nearly 100 locations that will be given either two 100-mcg injections of the vaccine or a placebo. Data from the trial is anticipated to come out in the fall.

Pfizer and BioNTech have started a phase 2/3 trial of one of their COVID-19 vaccine hopefuls. The companies are studying BNT162b2, a nucleoside-modified messenger RNA (modRNA) vaccine, in more than 30,000 participants in countries around the world, excluding China. The companies said they plan to seek Emergency Use Authorization or approval from the FDA in October if the trial is successful.

Johnson & Johnson has initiated a phase 1/2a study of its COVID-19 experimental vaccine in the U.S. and Belgium after seeing promising results in monkey testing. The trials will evaluate the vaccine, Ad26.COV2.S, in more than 1,000 healthy adults age 18 to 55, in addition to elderly patients age 65 and older. The company is also organizing a phase 2a study set to be conducted in the Netherlands, Spain and Germany, as well as a Japanese phase 1 study.

London’s Imperial College has expanded its COVID-19 vaccine trial to six additional British sites. The new sites will research the vaccine in more than 200 participants across Chelsea and Westminster Hospital, Imperial College Healthcare, St. George’s University Hospital, University College London, University of Surrey and University Hospital Southampton. They will enroll patients age 18 to 75 and administer two immunizations of the vaccine candidate spaced one month apart.

Merck plans to begin clinical testing of its COVID-19 vaccine candidate, V591, in the third quarter of 2020. Merck acquired Austrian drugmaker Themis BioSciences in June, bringing into its pipeline the vaccine Themis was developing with the Institut Pasteur and the University of Pittsburgh.

COVID-19 Treatments:

Roche’s rheumatoid arthritis med Actemra (tocilizumab) fell flat in a phase 3 trial studying it as a potential COVID-19 treatment for hospitalized patients. The drug compared to placebo showed a shorter time to patient discharge, although it was not statistically significant, and nearly identical mortality rates by week four. The company is pressing on, however, with two other phase 3 trials and a phase 2 trial in the hopes that they will lead to positive results for the drug.

Sanofi has begun dosing patients in its phase 1b study of DNL758, a small molecule inhibitor. The experimental drug, first discovered by Denali Therapeutics, is designed to inhibit RIPK1, a protein that regulates inflammation and cell death in various tissues. “The scientific rationale in treating severe COVID-19 with a RIPK1 inhibitor compound is to attenuate the exaggerated immune response to the viral infection and thereby limit potential tissue damage resulting from excessive inflammation and aim to improve patient recovery,” said Denali.

Humanigen’s monoclonal antibody lenzilumab has been picked for an upcoming National Institutes of Health trial of potential coronavirus therapeutics. The study will assess lenzilumab paired with remdesivir for treating hospitalized patients compared to placebo and remdesivir alone, with each trial arm enrolling 100 patients. The monoclonal antibody is currently in phase 3 trials for preventing and treating cytokine storms that lead to accurate respiratory distress syndrome (ARDS).

Celltrion has been cleared by the UK’s Medicines and Healthcare Products Regulatory Agency to begin a phase 1 trial of CT-P59, a potential antiviral antibody treatment for COVID-19. The trial will enroll patients with mild symptoms of infection. Another phase 1 trial currently ongoing in South Korea is studying healthy volunteers. The company said it anticipates results from phase 2/3 trials by the end of the year and has set a goal of starting commercial production in September.

Direct Biologics has been given the FDA’s blessing to start a phase 2 trial of ExoFlo, a bone marrow-derived extracellular vesicle and exosome product, for treating COVID-19-related ARDS. The randomized placebo trial will take place across three U.S. research sites and enroll 60 infected patients with moderate-to-severe ARDS.

Merck plans to launch two large phase 3 trials of its oral COVID-19 antiviral candidate, MK-4482, in September. The drugmaker has partnered with Florida-based Ridgeback Biotherapeutics to develop the product, which is currently in phase 2 clinical testing in the U.S. and the UK. Merck believes MK-4482 can reduce the duration of symptoms and keep people from being hospitalized or sent to the intensive care unit.