COVID-19 Drug Research Roundup

COVID-19 Therapies:

Gamaleya Institute’s COVID-19 neutralizing antibody vaccine, Sputnik V, is now under phase 3 investigation in the United Arab Emirates. Late-stage trials of the Russian vaccine are currently under way in Russia, Saudi Arabia, Belarus and the Philippines. There are also plans to investigate Sputnik V in Venezuela and India.

Russia has also announced that it has approved EpiVacCorona, a COVID-19 vaccine developed by the Vector Institute. This marks the second COVID-19 vaccine approved in the country, behind Sputnik V, that occurred ahead of a planned late-stage 30,000-participant trial.

Novavax is leading an effort to develop a single vaccine effective against both influenza and COVID-19, but work on the vaccine likely won't start until after the pandemic. Currently, the company is seeking FDA approval for NanoFlu, an influenza vaccine, based on positive findings from a late-stage study. Additionally, the company is in the process of developing its own separate COVID-19 vaccine, NVX-CoV2373, which is set to undergo phase 3 testing in late November. Efficacy data for Novavax’s COVID-19 vaccine candidate is expected in March 2021.

Trials studying COVID-19 vaccine candidates have largely left out children and adolescents. Pfizer is leading the U.S. by being the first company to enroll children as young as 12 in its global phase 3 COVID-19 vaccine trial of its vaccine candidate BNT162b2.

The University of Exeter in the UK is studying the tuberculosis Bacillus Calmette-Guerin (BCG) vaccine against COVID-19 in the new BCG vaccination to reduce the impact of COVID-19 in healthcare workers’ (BRACE) trial. A total of 10,000 healthcare staff at risk of COVID-19 transmission across centers in the UK, Australia, the Netherlands, Spain and Brazil will participate in this randomized, placebo-controlled trial. Global expansion of the BRACE trial is being made possible by $10 million in funding from the Bill and Melinda Gates Foundation.

Bharat Biotech won’t be able to move on to a 28,500-participant phase 3 study of its COVID-19 vaccine candidate Covaxin until complete safety and immunogenicity data from an ongoing phase 2 trial is submitted to the Drugs Controller General of India (DCGI). An application to conduct the phase 3 study has already been submitted to DCGI. The phase 2 trial is still ongoing, however, and some volunteers in this trial have yet to receive their second dose.

An unexplained illness in one patient participating in Johnson & Johnson’s COVID-19 vaccine study has caused the pharma company to pause its COVID-19 vaccine studies until an independent data safety monitoring board can review the safety event. The 60,000-patient trial has closed its online participant-enrolling system and has also paused all vaccine dosing.

A Taiwan government subsidy has been granted to Medigen and Dynavax to test a combination of their COVID-19 vaccine candidates in an open-label phase 1 trial in Taiwan. The total amount of the subsidy will reach up to $16.4 million, which will be released at agreed-upon milestones. A total of 45 healthy subjects between the ages of 20 and 50 will be enrolled in the trial. The first participant has been dosed with the combined vaccine product at the National Taiwan University Hospital.

Vaxart has dosed its first participant in an early-phase, dose-ranging study of oral VXA-CoV2-1, the company’s own COVID-19 vaccine candidate. The phase 1 trial is seeking to determine the safety and immunogenicity of low and high doses of the oral tablet in adults between 18 and 54 years of age. Preclinical data have already shown that the vaccine can produce immune responses and strong mucosal immune responses against SARS-CoV-2.

COVID-19 Therapies:

The National Institute of Allergy and Infectious Diseases (NIAID) has paused enrollment in its phase 3 trial evaluating Eli Lilly’s COVID-19 antibody treatment candidate at the recommendation of its independent data safety monitoring board. The company, which had just filed an application for Emergency Use Authorization for the treatment, did not share any details about the event that led to the pause.

The first participants have been enrolled in the National Heart, Lung and Blood Institute’s multicenter phase 2 study investigating fostamatinib, an oral spleen tyrosine kinase inhibitor from Rigel Pharmaceuticals, as a treatment for COVID-19.

Eli Lilly’s rheumatoid arthritis drug baricitinib in conjunction with Gilead Sciences’ antiviral remdesivir was associated with a 12.5 percent reduction in COVID-19 patient recovery time compared with remdesivir alone, according to new data from the Adaptive COVID-19 Treatment Trial (ACTT-2). The dual-therapy approach reduced time to recovery from eight to seven days. Based on the data from the ACTT-2, Eli Lilly is discussing with the FDA the possibility of an Emergency Use Authorization for baricitinib to treat hospitalized patients with COVID-19.

Additionally, Gilead Sciences released final results from a phase 3 remdesivir trial showing it helped patients improve in multiple areas compared to placebo and worked a day faster than previous results showed. The results, which come from the National Institute of Allergy and Infectious Diseases’ 1,062-patient phase 3 trial, showed that remdesivir plus standard of care shortened recovery time by four days, meeting its primary endpoint. According to the final day-29 results, patients given remdesivir achieved clinical recovery five days faster than placebo patients, with a median recovery time of 10 days for remdesivir and 15 days for placebo, a day faster than earlier results indicated.

AstraZeneca plans to test its experimental long-acting antibody combination AZD7442 in two new phase 3 clinical trials within the next few weeks. One trial will examine the efficacy and safety of AZD7442 for preventing infection for 12 months in 5,000 participants. The other study will investigate the potential of AZD7442 in preventing infection after exposure in 1,100 participants. Additional studies will test the combination therapy as a COVID-19 treatment in 4,000 adults with SARS-CoV-2 infections. Development and large-scale manufacturing of the combination therapy will be supported by a $486 million grant from the Biomedical Advance Research and Development Authority.

Biopharmaceutical company Apogenix has enrolled its first patient in a multicenter, open-label phase 2 ASUNCTIS trial. The study will evaluate the safety and efficacy of asunercept plus standard of care vs. standard of care alone in 400 patients with severe COVID-19. Regulatory approval for the trial has been granted in Spain and Russia.

Data from an open-label prospective study from Relief Therapeutics and NeuroRx show that treatment with RLF-100 (aviptadil) was associated with an 81 percent survival beyond 60 days in 45 patients with respiratory failure and severe COVID-19. In contrast, approximately 17 percent of patients who received the drug survived beyond 60 days. Overall, treatment with aviptadil was associated with a nine-fold increased probability of survival and respiratory failure recovery. Bachem Americas has agreed to manufacture the treatment, upon approval, in quantities that will treat 1 million patients.

Clinical-stage specialty pharmaceutical company TLC has enrolled its first participant in a phase 1 trial of TLC19, an inhalable treatment or prophylactic therapy for COVID-19. The company’s treatment is a proprietary liposomal formulation consisting of a small amount of hydroxychloroquine. The trial will evaluate the tolerability, safety and pharmacokinetics of single ascending doses of the inhaled therapy in 30 healthy volunteers.

Tevogen Bio has submitted an Investigational New Drug application to the FDA to develop a T-cell treatment for COVID-19. The company will evaluate its proprietary antigen-specific T-cell technology for treating hospitalized patients with COVID-19 in future clinical trials.

Treatment with Recipharm’s proprietary molecule Erdosteine improved health-related quality of life parameters and dyspnea in a trial of 20 patients with COVID-19 and severe respiratory failure. The study was conducted in Italy. Plans are under way to begin additional studies of Erdosteine.

Sorrento Therapeutics has received authorization by the Brazilian Health Regulatory Agency to conduct a phase 2 trial of abivertinib in patients with mild, moderate and severe COVID-19. The study will be conducted in Brazil and will enroll 400 patients. Treatment will be given for only seven days, compared with the 14-day protocol in a U.S. trial.

Grifols has started a phase 3 trial for its anti-coronavirus hyperimmune globulin, a treatment derived from the plasma of recovered COVID-19 patients. The trial is being conducted in collaboration with HHS’ Biomedical Advance Research Development Authority, the National Institute of Allergy and Infectious Diseases, and the FDA to see if the treatment can strengthen antibody response and reduce the risk of serious illness or death if taken when initial symptoms arise. The trial will enroll 500 patients in 18 countries, and the participants will be given either a combination of the convalescent plasma treatment and remdesivir or placebo and remdesivir.