COVID-19 Drug Research Roundup

COVID-19 Vaccines:

Sanofi’s CEO Paul Hudson announced that the company’s recombinant vaccine, which is using an adjuvant developed by GlaxoSmithKline, is expected to enter a phase 1/2 study in September, faster than originally anticipated. Hudson said that the drugmaker’s vaccine candidate could receive approval by the first half of next year.

Chinese biotech Clover Biopharmaceuticals has dosed the first participants in a phase 1 trial of its coronavirus vaccine candidate. The Australian study, which is expected to enroll 150 patients, is also evaluating adjuvants from its research partners, Dynavax and GlaxosmithKline. Each dose level will be evaluated with and without the adjuvants. The company expects preliminary results to come out in August and hopes to start an international phase 2/3 trial by the end of the year.

Avalon GloboCare has formed a partnership with Vienna, Austria’s University of Natural Resources and Life Sciences (BOKU) to develop a COVID-19 vaccine that can be taken intranasally or orally rather than by injection. The two have already begun development of the S-layer protein-based vaccine candidate. It is anticipated to both lessen the severity of COVID-19 infection, preventing more severe respiratory inflammation and organ damage, and help patients build an immunity to the virus.

Imperial College London has dosed the first participant in a phase 1 trial of its RNA-based COVID-19 vaccine candidate. The trial will evaluate the safety of the vaccine and determine optimal dosage. In its initial stage, it will vaccinate 15 healthy volunteers, beginning with a low dose and rising to higher doses for subsequent volunteers. Overall, the college plans to enroll 300 healthy participants over the coming weeks and to start larger trials later this year.

COVID-19 Therapeutics:

Gilead Sciences has gotten the greenlight from the FDA to launch a phase 1 trial of an inhaled version of its antiviral remdesivir for earlier treatment of COVID-19 patients. The drugmaker said it plans to begin trials in August.

The National Institutes of Health and Novartis have ended late-stage hydroxychloroquine trials after growing evidence suggests the drug is not effective as a COVID-19 treatment. The NIH ended both a phase 2 and a phase 3 trial, while Novartis terminated a phase 3 trial.

Fulcrum Therapeutics has started a phase 3 clinical trial of its investigative anti-inflammatory drug losmapimod for treating hospitalized COVID-19 patients. The trial will enroll 400 patients at risk of progressing to critical illness based on their age and elevated systemic inflammation. Preliminary results are expected in the fourth quarter.

FibroGen has begun a phase 2 trial evaluating its monoclonal antibody pamrevlumab as a treatment for hospitalized COVID-19 patients. The trial will take place at multiple centers in the U.S. and assess the drug’s effect on blood oxygenation in 130 infected patients.

Ridgeback Biotherapeutics in July will launch a pair of phase 2 studies of its investigational antiviral EIDD-2801 as a potential COVID-19 treatment. The company said the antiviral has already shown safety and promise in phase 1 studies. One study will assess the drug in newly hospitalized patients, while the other will test the drug in newly diagnosed patients who have not been hospitalized.

Ambio Pharmaceuticals will start a phase 1 clinical trial evaluating its investigational pain treatment Ampion (aspartyl-alanyl diketopiperazine) in COVID-19 patients. The company said it believes the nonsteroidal anti-inflammatory drug could help treat inflammation and improve patient outcomes.

Noxopharm, an Australian drug developer, has begun planning a phase 1 trial of its investigational oncology drug Veyonda (NOX66) in Europe to evaluate its potential as a treatment for cytokine storm and septic shock caused by COVID-19 infection.

Berlin Cures said it will start a phase 2/3 COVID-19 trial of its investigational BC 007, a ?1-adrenoceptor autoantibody (?1-AAb) neutralizing ssDNA product, in the second half of 2020. The drug was found to be safe and well tolerated in a previous phase 1 study for a cardiac indication, the German biotech said.

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has given its blessing to Gilead Sciences’ remdesivir, recommending it for emergency use in treating COVID-19. The committee based its decision on results from the NIH’s National Institutes of Allergy and Infectious Diseases (NIAID) remdesivir trial, which showed that COVID-19 patients recovered more quickly on the drug compared to those taking a placebo. Generally, the EMA follows the committee’s recommendations.