Sponsors are targeting Covid-19 variants in pivotal and registrational trials

GlobalData Healthcare 29th March 2021 (Last Updated March 29th, 2021 17:16)

With the WHO declaring the COVID-19 outbreak a pandemic on March 11, 2020, the resulting global burden has persisted for over a year, devastating healthcare systems and economies alike. However, this period has also been marked by an unprecedented level of innovation with several vaccines being developed and rolled out along with the identification of effective therapeutics.

With the WHO declaring the COVID-19 outbreak a pandemic on March 11, 2020, the resulting global burden has persisted for over a year, devastating healthcare systems and economies alike. However, this period has also been marked by an unprecedented level of innovation with several vaccines being developed and rolled out along with the identification of effective therapeutics.

In this article we examine the current landscape of ongoing and planned COVID-19 trials. The greatest proportion of ongoing and planned COVID-19 clinical trials are in Phase II status (44.8%), significantly outnumbering Phase III trials (26.8%). In third place, Phase I clinical trials (19.1%) outnumber Phase IV studies, which hold the smallest proportion of trials (9.3%). Regarding trial status, most active COVID-19 studies are either in the ongoing recruiting stage (50.5%) or in a planning stage (42.3%), with 7.2% of studies ongoing but not recruiting.

The US is currently dominating the research landscape where ongoing and planned trials are concerned with 17.1% of trials, surpassing China’s initial research dominance in the earlier stages of the pandemic timeline. India holds second place with 10.2% and China follows in third place with 9.7% of studies, more than double that of fourth-placed Spain (4.6%). Brazil rounds of the top five with 4.2% of clinical trials while also having the current highest number of daily deaths worldwide. Sorrento Therapeutics is the industry sponsor with highest number of COVID-19 trials currently in development, 16. They are developing a range of antibody therapeutics, most notably an intranasal antibody (STI-2099) for mild COVID-19 infections. The drug is expected to prevent infection at the earliest stage in the nasal passages, preventing the infection from spreading to the lungs and ultimately avoiding serious complications. The FDA granted Investigational New Drug (IND) clearance to proceed with Phase I trials earlier this month.

AstraZeneca’s vaccine AZD1222 currently has the highest number of pivotal studies in planned and ongoing stages of development (4). The US currently has the highest number of planned and recruiting pivotal trials (26). Brazil holds second place with 15, followed by South Africa with 11 with both the UK and Spain following with 10 studies each. Notably, three of the top countries holding the highest number of pivotal studies (Brazil, South Africa, and the UK) are the countries with the most prevalent cases involving COVID-19 variants, suggesting that sponsors are taking a targeted approach in selecting these regions for pivotal studies in order to determine vaccine efficacy against arising variants. Thus, the vaccines and therapies which display high level of efficacies against the variants are more likely to be approved by regulators and at a faster pace.