In its first-quarter results posted today, Big Pharma Pfizer said it is beginning to reopen some stalled trials and is now months ahead of schedule to develop a potential new med against COVID-19.
A month ago, just as the pandemic was picking up pace in the U.S. and Europe and lockdowns began, Pfizer said it was hitting pause on enrollment in many new and ongoing clinical trials in response to COVID-19.
But in the past few days, the U.S. giant said (PDF) it has now begun “to restart recruitment across the development portfolio, including new study starts, at all clinical trial sites that are currently operational” and where Pfizer and investigators are able to “monitor safety.”
Virtual Clinical Trials Online
This virtual event will bring together industry experts to discuss the increasing pace of pharmaceutical innovation, the need to maintain data quality and integrity as new technologies are implemented and understand regulatory challenges to ensure compliance.
Pfizer said it would work with investigator sites to “ensure their readiness” before any new study participants are enrolled, but added that finishing off some tests currently in the recruitment stage or studies that have yet to begin “could be delayed.”
“For all ongoing clinical trials, Pfizer is working closely with clinical trial sites to understand their needs and is performing remote monitoring to oversee study conduct,” the company added. It’s also using virtual health, telehealth and home health care-based tech “where appropriate” to continue the data collection process.
As well as navigating through the pandemic, it’s also looking to help put a stop to it: After announcing a vaccine development plan with BioNTech, which got the all-clear to start in Germany last week and should gain U.S. approval any day now, Pfizer is also working on seeking out a treatment against those infected with COVID-19.
While very early stage, Pfizer said after screening for candidates against the virus it has preliminary data that “suggest” its lead protease inhibitor “shows antiviral activity against SARS-CoV-2,” the virus causing COVID-19.
The plan now is to push on with preclinical confirmatory studies, but it’s ramping up investment for materials that will be used to kick-start a human test of its lead molecule in the third quarter of this year, which it notes is “three or more months in advance of earlier estimates,” should preclinical work go to plan.