COVID-19 Drug Research Roundup

COVID-19 Vaccines:

AstraZeneca has kicked off a phase 3 U.S. trial for its COVID-19 vaccine candidate. The study will look into the safety, efficacy and immunogenicity of AZD1222 in 30,000 healthy adults aged 18 and up at more than 101 sites. Patients will receive either two doses of the vaccine or a placebo four weeks apart. The drugmaker said it expects to see results later this year, the timing for which will depend on the speed of patient enrollment and the transmission rate of COVID-19 across the country.

Johnson & Johnson (J&J) has initiated a phase 2 trial of its COVID-19 vaccine candidate, Ad26.COV2.S, in Spain, Germany and the Netherlands. The trial will enroll up to 550 healthy volunteers aged 18 to 55 years and older than 65 years and will examine different vaccine doses and methods of administration. While J&J only began phase 1 trials last month, the company is working on initiating a 60,000-participant phase 3 trial for the vaccine candidate in early September.

Chinese pharma companies Sinovac Biotech and Sinopharm received emergency clearance in July for two dose-inactivated COVID-19 vaccine candidates. The authorization clears the two vaccines for use in China’s high-risk population, according to recent announcements made by China’s National Medical Products Administration. Currently, it’s unclear which Sinopharm candidate has been granted an Emergency Use Authorization in China. The pharma companies are in the process of conducting late-stage trials of their COVID-19 vaccines.

Sanofi and GlaxoSmithKline have begun a U.S. phase 1/2 clinical trial of their COVID-19 vaccine. The trial will enroll 440 healthy adults and compare the vaccine to a placebo, in addition to evaluating its safety, tolerability and ability to induce an immune response. Data is expected in December and will determine the viability of a phase 3 trial.

Pfizer announced it has reached 23,000 volunteers for a phase 3 trial of its mRNA COVID-19 vaccine candidate BNT162B2. Based on the number of people currently enrolled, Pfizer believes there should be enough data by the end of October to know whether or not the product works.

COVID-19 Therapies:

In a Sept. 1 announcement, Aerpio Pharmaceuticals and Quantum Leap Healthcare Collaborative report that the first patient has been dosed in their phase 2 I-SPY COVID trial, which is investigating razuprotafib for the treatment of acute respiratory distress syndrome in critically ill patients with COVID-19. While this study arm is examining the effects of razuprotafib, the overarching goal of the I-SPY COVID trial is to screen multiple agents to find therapies that can reduce mortality and avoid or reduce mechanical ventilation in critically ill patients with COVID-19.

BioCryst Pharmaceuticals has landed a $44 million contract with the National Institute of Allergy and Infectious Diseases to advance its COVID-19 drug, galidesivir, in clinical trials. The funding will support completion of an ongoing trial in Brazil and the initiation of a phase 2 trial of galidesivir in nonhospitalized patients with COVID-19 who are at high risk for severe disease and complications. In addition, the contract will help BioCryst launch a pharmacology trial to identify appropriate dosing of galidesivir in patients with concomitant renal impairment. The funding will also be used to help the pharma company increase their supply of the drug.

FSD Pharma has submitted an Investigational New Drug Application to the FDA for its anti-inflammatory COVID-19 therapy, FSD201 (ultramicronized palmitoylethanolamide or ultramicronized PEA). The drug will be tested in a randomized controlled trial, which plans to enroll hospitalized patients with COVID-19. FSD201 will be administered at 600mg or 1200mg doses twice daily and combined with standard of care and compared to standard of care alone.

GlaxoSmithKline and Vir Biotechnology have announced the first patient has been dosed with anti-SARS-CoV-2 monoclonal antibody VIR-7831 in their phase 2/3 COMET-ICE trial. The study is investigating the use of VIR-7831 for early treatment of COVID-19 in patients at high risk of progressing to more severe disease, an especially important concern among the elderly and individuals with pre-existing conditions. While complete results are expected in the first quarter of 2021, initial results may be available before the end of 2020. The companies also suggest that early access to the therapy could be available by the first half of 2021.

After a failed COVID-19 study of interleukin-6 therapy sarilumab, Sanofi and Regeneron have announced they are shifting their COVID-19 research elsewhere. The study, which enrolled 420 patients across several countries in South America and Europe as well as in Japan and Canada, didn’t meet its endpoints. While those who received the rheumatoid arthritis drug had shorter hospital stays and improvements in their condition compared with a placebo, the differences between the two groups were not significant. The companies announced in July similar disappointing results from a separate phase 2 U.S. trial of the drug. In terms of future directions, Sanofi is currently in the process of advancing two COVID-19 vaccine candidates, and Regeneron has placed its focus on an antibody therapy against COVID-19.

Corticosteroids may reduce the risk of death in patients with severe COVID-19, according to a meta-analysis led by University of Bristol’s National Institute for Health Research and the World Health Organization (WHO). The analysis included seven international randomized controlled clinical trials of dexamethasone, hydrocortisone and methylprednisolone with a pooled cohort of 1,703 critically ill patients with COVID-19. Overall, treatment with either corticosteroid was associated with a 20 percent reduced risk of mortality in patients with COVID-19. This equaled to approximately 68 percent of patients surviving after therapy compared with 60 percent surviving without corticosteroids. The analysis was published in a recent edition of the Journal of the American Medical Association. Following the publication of this study, the WHO updated its treatment guidance to include a “strong recommendation” for corticosteroids for patients with severe and critical COVID-19.

RedHill Biopharma says it plans to file for an Emergency Use Authorization for opaganib for use in patients with severe COVID-19, subject to positive findings from two late-stage clinical trials. One of these studies is a global phase 2/3 trial approved by the Italian Medicines Agency. This trial, conducted across 40 sites, is evaluating opaganib vs. a placebo with standard of care in up to 270 patients with severe COVID-19 who require hospitalization and supplemental oxygen. The other trial is a continuation of a phase 2 study in the U.S., which is examining opaganib vs. a placebo in 40 hospitalized patients with severe COVID-19 who also require supplemental oxygen.

Nocion Therapeutics has signed on a new chief medical officer as it kicks into gear with a phase 1 trial of NOC-100, an inhaled version of Nocion’s lead program, NTX-1175, for the treatment of chronic and acute cough in patients with COVID-19. Christopher Silber, who was appointed to the chief medical officer role, will be involved in the study, which got a phase 1 approval from the UK Medicines and Healthcare products Regulatory Agency last month. The early-stage trial will start by enrolling only healthy volunteers.