COVID-19 Drug Research Roundup

COVID-19 Vaccines:

PT Bio Farma is set to start clinical trials of Sinovac Biotech’s COVID-19 vaccine CoronaVac next month and has announced that it will begin commercial production in early 2021. The president director of PT BioFarma has said that it has secured 2,400 doses of the vaccine, which will be administered to 1,620 people age 18 to 59. The trials are expected to be completed in just six months.

The Brazilian government has authorized trials for a potential COVID-19 vaccine under development by Pfizer and BioNTech. This will be the third vaccine that has been tested in Brazil.

At least one human volunteer in Brazil has been injected with a potential COVID-19 vaccine developed by Sinovac Biotech.

Phase 2 clinical trials have been completed on a COVID-19 vaccine developed with the Russian Defense Ministry. As testing of this vaccine continues, state-run virology center Vector is working on an inoculation. The phase 3 trials are expected to begin Aug. 3 and to enroll thousands of people in the United Arab Emirates, Saudi Arabia and Russia. Distribution of the vaccine is planned for as early as September.

Clinical trials for an mRNA-based vaccine candidate for SARS-CoV-2 secured by Gennova Biopharmaceuticals are planned to begin by October. The company’s optimistic launch date for the vaccine is set at around March 2021, a date that is contingent upon the successful completion of phase 1 and phase 2 trials. These clinical trials will enroll two groups of patients, including patients age 18 to 55 and patients age 55 to 70. Gennova, which initiated the vaccine program HGCO19 with HDT Bio in January, plans to distribute 200 million doses of its vaccine next year.

A COVID-19 vaccine developed by the Imperial College London is moving to its next phase of clinical trials following the successful completion of the initial phase that included 15 human volunteers. A total of 105 participants age 18 to 75 will be enrolled in the next blinded, randomized trial, which will compare three different doses of the vaccine plus a booster four weeks later.

Interim results from a phase 1/2 clinical trial in the UK has shown that a COVID-19 vaccine, developed jointly by AstraZeneca and the University of Oxford, produces strong immune responses in healthy adults age 18-55. The trial included 1,077 participants and compared a single dose of AZD1222 with a meningitis vaccine. Currently, the vaccine is in phase 3 testing in the UK, South Africa and Brazil. The vaccine is expected to enter a phase 3 trial in the U.S. this summer.

A single shot of CanSino Biologics’ experimental COVID-19 vaccine Ad5-nCoV also led to immune responses in greater than 90 percent of 508 patients who participated in a phase 2 trial. The trial reported that the vaccine was safe, featured mild or moderate reactions and did not cause any serious adverse events (SAE) among participants.

In an ongoing phase 1/2 study in Germany, a COVID-19 vaccine candidate from the BNT162 mRNA-based vaccine program started by Pfizer and BioNTech elicited high SARS-CoV-2 neutralizing titers just after the second dose. The study reported that the BNT162b1 vaccine candidate also induced strong CD4+ and CD8+ T-cell responses. Results from this phase 1/2 trial follow encouraging results earlier this month from the U.S. cohort, which showed that treatment with the vaccine candidate was associated with higher antibody levels at day 28 compared with convalescing patients with COVID-19. A larger phase 2/3 trial with 30,000 participants is planned to start this month on the condition of regulatory approval. If the vaccine is approved, both Pfizer and BioNTech say they plan to manufacture nearly 100 million doses by the end of 2020 and possibly greater than 1.3 billion doses by 2021 end.

COVID-19 Treatments:

As part of a phase 2 trial in the UK, Synairgen’s antiviral SNG001 reduced the risk of severe COVID-19 in patients hospitalized with the disease. The phase 2 trial, which began in March, compared SNG001, an inhaled formulation consisting of interferon-beta-1a, with a placebo in 101 patients across nine different UK hospitals. Patients taking the antiviral agent in the trial experienced a 79 percent reduction in the risk of developing severe disease compared with a placebo. Additionally, the trial demonstrated that SNG001-treated patients were twice as likely to recover during treatment compared with patients assigned to a placebo.

InflaRx has announced that it will enter phase 3 trials for IFX-1, the company’s lead drug candidate for severe COVID-19-induced pneumonia. This news follows promising initial data from the randomized exploratory phase 2 part of a phase 2/3 trial, which showed that treatment with IFX-1 was associated with approximately 50 percent lower all-cause mortality compared with best supportive care alone among 30 participants. The phase 3 trial will enroll 360 early intubated, critically ill patients with COVID-19-induced pneumonia, with an interim analysis planned following enrollment of the first 180 patients.

A phase 2 trial from CytoDyn shows that treatment with leronlimab, a potential COVID-19 therapy, was associated with significantly fewer serious adverse events (SAEs) compared with a placebo in patients with mild-to-moderate COVID-19. The study included 28 patients who were randomized to placebo and 56 patients who were randomized to leronlimab. Only 8 SAEs were reported in five patients in the leronlimab arm (8.9 percent), whereas 11 SAEs were reported in six patients in the placebo group (21.4 percent). CytoDyn is continuing to enroll patients across the country in its phase 2b/3 randomized trial of leronlimab for severe and critically ill patients with COVID-19.

Favipiravir, an antiviral agent from Glenmark Pharmaceuticals, helped patients with COVID-19 clear the virus approximately 28.6 percent faster than patients who took placebo in a phase 3 study. In this trial, there were no reported SAEs or deaths associated with the drug. Around 70 percent of patients who were randomized to favipiravir also achieved normalization of symptoms by day four compared with less than 45 percent of patients who were treated with supportive care alone. Last month, Glenmark was given the green light to market favipiravir (FabiFlu) for treating mild-to-moderate COVID-19 infections. Currently, the India-based pharma company is conducting a postmarket surveillance study that will monitor the drug’s safety and efficacy in 1,000 patients.

RedHill Biopharma has added Brazil and Mexico to its list of countries to evaluate opaganib in its phase 2/3 study for the treatment of patients with severe SARS-CoV-2 infection and pneumonia. The company’s clinical trial applications (CTAs) for the trial have previously been approved in the UK and Russia, and another CTA application is under review by Italian authorities. The placebo-controlled trial will enroll up to 270 patients with severe COVID-19 pneumonia who require hospitalization and supplemental oxygen. Patients will be randomly assigned to either opaganib or a placebo, both of which will be added to standard of care. RedHill said that in an analysis of five patients with severe COVID-19 penuomia, treatment with opaganib conferred significant benefit in terms of clinical outcomes and inflammatory markers.