Until now there have been more than 585 clinical trials focused on the treatment of the infectious disease COVID-19, which affected more than 4 million people since January 2020 and killed approximately 300,000 people around the world. 72% of these treatments and vaccines are in the discovery or preclinical stage. The race in the development of the drugs and vaccines which could help the fight against the SARS-CoV-2 is picking up pace with more and more pharmaceutical and biotechnology companies beginning their own clinical trials or forming the collaborations. Although optimism around developing the vaccines or drugs is raising, history shows that we should be patient because a finished product is unlikely to be widely available before the end of 2020.
At the end of April, the Germany based biotechnology company BioNTech SE, which has partnered up with Pfizer to develop its mRNA vaccine, started Phase I/II clinical trials of the vaccine in Germany, where twelve study participants were dosed since 23rd April 2020. In the first week of May, the first patients were dosed in the USA. They are planning to enroll around 360 healthy subjects into two cohorts (aged 18-55 and 65-85 years). This study is designed to investigate the appropriate dosage (in the range of 1 µg to 100 µg), safety and immunogenicity for four versions of the candidate vaccine, BNT-162. The sites will include NYU Grossman School of Medicine, University of Maryland School of Medicine, University of Rochester Medical Center and Cincinnati Children’s Hospital Medical Center.
Furthermore, BioNTech SE is collaborating with Focus Pharma to develop BNT-162 in China, where the companies are expecting to soon conduct clinical trials.
ModernaTX Inc., the developer of mRNA-1273 candidate vaccine against SARS-CoV-2 just received approval from the Food and Drug Administration (FDA) to start its Phase II clinical trial in humans. The company is planning to enroll 600 subjects and is already planning for Phase III trials to start in the summer. This is in preparation to potentially have its first BLA (biologics license application) approved as soon as 2021. Alongside this and in anticipation for approval, they are accelerating the scaling up of manufacturing by means of their partnership with Lonza.
In Phase II, scientists are going to assess the safety, reactogenicity, and immunogenicity of two doses of the mRNA-1273 vaccine given 28 days apart. Each of the 600 subjects will be assigned to receive placebo, 50 µg or 250 µg dose at both vaccinations as part of the randomized trial. Participants will be followed up through the 12 months after their second vaccination.
In the last week, the National Institute of Allergy and Infectious Diseases (NIAID) launched a clinical trial to assess remdesivir, the antiviral drug developed by Gilead Sciences plus baricitinib, the anti-inflammatory drug by Eli Lilly in patients with confirmed COVID-19. Bariticinib is designed for adult patients with moderately to severe active rheumatoid arthritis and scientists are going to study if bariticinib could inhibit cytokine signalling that is associated with inflammatory responses in acute respiratory distress caused by COVID-19.
The new NIAID trial, named ACTT2, follows the ACTT trial that assessed remdesivir alone in COVID-19 patients. ACTT enrolled 1,063 subjects at 47 US and 21 international sites, and similarly ACTT2 is designed to recruit approximately 1,000 hospitalised patients at around 100 US and international sites. Participants in the ACTT2, controlled, double-blind study will be randomised to receive remdesivir alone or remdesivir plus bariticinib. Remdesivir will be given as one 200 mg i.v. dose followed by a 100 mg once-daily i.v. dose, daily for up to a ten-day treatment course during hospitalisation. Bariticinib will be given as a 4 mg oral dose for the duration of hospitalisation up to a 14-day total treatment course.
The main goal of this trial is to compare the time to recovery between remdesivir alone and remdesivir plus bariticinib arms. A secondary outcome is patient outcomes at day 15.
All of these developments increase the chance to find a successful candidate for the treatment of COVID-19 patients, however, many of the novel techniques used for COVID-19 (vaccines or drugs) have yet to be proven to be safe and efficacious in humans. Because of this and the pace of progress, it is unlikely that we will get a vaccine or working drug candidate available for mass rollout until the end of 2020 or beyond.