COVID-19 Drug Research Roundup

COVID-19 Vaccines:

A COVID-19 vaccine developed by Moscow’s Gamaleya Institute, Sputnik V, has received Russian regulatory approval. Concerns about the safety of the vaccine were heard around the globe as the vaccine has only recently entered a phase 3 trial and has not yet been extensively tested in large numbers of patients. Early phase trials of the vaccine concluded on Aug. 1. Russian President Vladimir Putin defended the vaccine’s approval, saying it “works fairly effectively… forms stable immunity and … has gone through all the necessary checks. It forms stable antibody and cell-mediated immune response.” Putin said the vaccine will become available to the public on Jan. 1.

A potential COVID-19 vaccine has been in development for the past six months, headed by the Israel Institute of Biological Research (IIBR). The IIBR began testing the vaccine in animals in March and has announced that it will begin clinical trials in humans as early as October.

Due to slow enrollment in its vaccine trial, experts believe Moderna’s odds for a COVID-19 vaccine approval this year are slim. The company says it plans to recruit 30,000 participants for the trial by September, but only around 54 of the 89 sites are online. It’s possible that results from this trial won’t become available until the first quarter of 2021.

CanSino Biologics is launching a COVID-19 phase 3 trial in Saudi Arabia, which will test the company’s candidate COVID-19 vaccine Ad5-nCoV. The study will enroll at least 5,000 healthy adults. So far, early phase trials have shown that Ad5-nCoV produces antibodies and good immune responses in healthy volunteers, and a phase 2 trial of the candidate showed promising immune responses in more than 90 percent of participants after a single dose.

CEO of Russian Direct Investment Fund, Kirill Dmitriev, announced the fund is ready to conduct trials for a COVID-19 vaccine in the Philippines this month. Russia has already developed the country’s first COVID-19 vaccine, which entered clinical trials on June 18 and enrolled 38 volunteers. Immunity was reportedly developed in all participants.

Sinopharm has started a phase 3 trial of a COVID-19 vaccine in Bahrain. The trial plans to enroll 6,000 citizens and residents in Bahrain over a 12-month period. Last month, Sinopharm launched a similar trial in the United Arab Emirates that administered up to 5,000 vaccinations.

Sinovac has begun a phase 3 trial of its vaccine candidate, CoronaVac, in Indonesia. The Chinese firm is partnering with the state-owned Indonesian drugmaker Bio Farma on the study. Bio Farma said it anticipates starting commercial production of the vaccine in six months.

Mexico has signed memorandums of understanding on COVID-19 vaccines with CanSino Biologics, Walvax Biotechnology and Johnson & Johnson, and is set to launch several phase 3 COVID-19 vaccine trials with these companies between September and January.

Johnson & Johnson has announced the launch of a phase 1/2 trial, which will be conducted in the U.S. and Belgium to investigate its COVID-19 vaccine candidate, Ad26.COV2.S. Another phase 1 trial of the vaccine will be conducted in Japan, while a phase 2 trial of the candidate will be conducted in the Netherlands, Spain and Germany.

Meanwhile, Arcturus Therapeutics has started a phase 1/2 trial of ARCT-021, a COVID-19 vaccine candidate, in Singapore. The trial is in collaboration with Duke-NUS Medical School.

Results from a U.S.-based phase 1/2 trial from Pfizer’s and BioNTech’s COVID-19 vaccine candidate BNT162b1 have been published in Nature, offering some promising results. The findings demonstrate that a second 30-mcg dose of BNT162b1 produces neutralizing antibodies at levels 2.8 times seen in recovered patients’ plasma. The levels of these antibodies continued to rise up to 4.6 times higher than observed in convalescent plasma at a total of 14 days following the second dose.

COVID-19 Therapies:

A new phase 3 trial from the NIH’s National Institutes of Allergy and Infectious Diseases is harnessing Gilead Sciences’ remdesivir in conjunction with Merck’s anti-inflammatory drug Rebif, an interferon-beta-1a, to study the combination’s effect in hospitalized patients with COVID-19. The trial, which is expected to recruit 1,000 patients across 100 sites in the U.S. and Europe, will test whether the combination regimen will reduce recovery time vs. remdesivir monotherapy. Only small clinical trials have so far reported a benefit with Rebif in patients with COVID-19. An ongoing clinical trial is currently evaluating remdesivir plus Eli Lilly’s Olumiant (baricitinib).

Brazil’s health agency has picked Humanigen’s lenzilumab to test the treatment’s effect in adult hospitalized patients with severe and critical COVID-19 who are at high risk for disease progression. The phase 3 trial is an expansion of Humanigen’s study being conducted in the U.S.

Omeros’ monoclonal antibody drug narsoplimab was effective for aiding the recovery of six hospitalized patients with COVID-19 who were administered the treatment in a compassionate use program. All six patients were on ventilators due to acute respiratory distress disorder, yet all recovered without treatment-related adverse effects.

A phase 2/3 trial of Vir Biotechnology’s neutralizing monoclonal antibody VIR-7831 is set to begin this month. The study will test the treatment effect of VIR-7831 for early COVID-19 infections and hospitalized patients and will also investigate its prophylactic use against COVID-19. Preclinical studies have already demonstrated that the antibody may neutralize the SARS-CoV-2 virus. Based on current findings, Vir believes VIR-7831 can protect against COVID-19 for up to six months. A separate phase 2 trial is in the works at Vir, this time with a different neutralizing antibody, VIR-7382, which the company says may act as a treatment and prophylactic therapy against COVID-19. Additionally, preclinical studies of VIR-2703, an inhaled small-interfering RNA antibody developed by Vir and Alnylam Pharmaceuticals for the treatment of COVID-19, are expected to be completed sometime this year.

RedHill Biopharma’s phase 2/3 trial of Yeliva (opaganib) has been approved by Mexico’s drug regulators. The placebo-controlled trial will enroll 270 hospitalized patients with COVID-19 and pneumonia, and will compare opaganib- and placebo-treated groups in terms of the proportion of patients who require intubation and mechanical ventilation by 14 days. Russia and the UK have already approved the trial, and RedHill is currently waiting for Italy and Brazil to follow suit. The pharma company is also rounding out its enrollment phase of a U.S. trial of opaganib for severe COVID-19, which is expected to enroll 40 hospitalized patients with pneumonia. RedHill is hopeful that it will submit global emergency use applications for the drug for potential COVID-19 treatment as early as the fourth quarter of this year.