Louisiana’s Ochsner Medical Center in Jefferson Parish is actively contributing its medical, scientific and research talents in the ongoing bid to combat the COVID-19 pandemic. Partnering with industry sponsors such as Eli Lilly, one the health provider’s prestigious principal investigators, Dr. Corey Herbert, recently was showcased on a local radio show hosted by Newell Normand. Dr. Herbert discusses the Blaze-1 clinical trial sponsored by Eli Lilly and AbCellera Biologics and the joint investigation into what is purported to be the world’s first antibody treatment targeting COVID-19 known as LY3819253. The investigational product was the result of a brilliant group of researchers at University of British Columbia and their spinoff venture, early on DARPA funding, and some impressive work by Lilly scientists to crank out investigational prospects in record time. Will the study show results?
What follows is a TrialSite summary of the discussion. Follow the link to WWL to listen to Dr. Herbert discuss these important clinical trials.
The interview introduced the Blaze-1 Study, a Phase 2 clinical trial sponsored by the prominent American pharmaceutical company Eli Lilly and a collaborative biotech partner called AbCellera Biologics.
What is the Blaze-1 Study?
Eli Lilly and partner AbCellera collaborated with up to 49 sites, including Ochsner Medical Center, to measure how well an investigational therapy called LY3819253 works against SARS-CoV-2, the virus behind COVID-19. The study team is administering LY3819253 to participants with early symptoms of COVID-19, via an injection to a vein. They are also collecting samples from the back of the nose to determine how much of the virus is in the body at various times during the clinical trial. Actual subject participation extends for up to 12 weeks and involves at least one required visit to the study sites: the remainder of the study assessments can be performed with the subject in their home or by the phone.
The Phase 2 clinical trial was initiated in June and runs through to August 12, 2020 and includes a target of 400 participants. The primary outcome measure established centers on the observed change from “Baseline to Day 11 in…SARS-CoV-2,” which involves measuring the change in viral load from baseline to Day 11. Secondary outcome measures can be viewed here.
What is LY3819253?
In June, Eli Lilly announced the first dosing of the world’s first study of a potential antibody treatment designed to battle COVID-19. The investigational product known as LY-CoV555/ LY3819253 was the first to emerge out of a dynamic partnership between a renowned American pharmaceutical company, Eli Lilly, and an agile biotech called AbCellera. Lilly scientists had developed this antibody in only three months after AbCellera and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID) identified it from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.
The very first patients for this investigational drug were dosed at NYU Grossman School of Medicine as reported by the TrialSite as well as Cedars-Sinai Los Angeles.
The TrialSite reported that LY-CoV555/ LY3819253 consists of identical copies of an antibody, a blood protein related to those that naturally occur as part of the human immune system. Lilly employed the platform of AbCellera, which originates out of the University of British Columbia, to identify antibodies that most tightly attached to the virus in places known to block its ability to infect human cells (neutralizing antibodies). The TrialSite introduced that this technology provided by AbCellera originated from a brilliant group of researchers up at University of British Columbia.
Research at the TrialSite
Now Dr. Corey, the principal investigator for the Ochsner Medical Center trial site, conveys to Newell Normand the importance of this research for the New Orleans, LA region. The principal investigator commented, “So what this is all about is, we know we are working on a vaccine, everybody knows that, but we really don’t have anything except for remdesivir, to stay we are going to treat this as it happens.”
Conveying the importance of being able to treat this virus early on (and hence stopping it from progressing to the severe or worse the critical state), Dr. Corey continued, “We want to be able to have a drug; where if you get a COVID-19 diagnosis and within three days you can get an infusion, and be straight, be good, and that is what we are doing here.”
The Importance of Clinical Trial Participation
Dr. Herbert conveyed to the radio show audience deep in the South that clinical trials are absolutely key to combat this pandemic, declaring, “if we don’t do clinical trials, and we don’t participate in studies, then we won’t have the answer.” The doctor urged people to “Step up and do this.” A large study involving sites from Johns Hopkins to Massachusetts General Hospital, Herbert expressed his feeling that New Orleans was fortunate for the opportunity to participate.
Call to Action: If you are based in New Orleans area and interested in learning more, call 504-408-1126. Follow the link to the radio show. The TrialSite is monitoring the investigation into LY3819253 and will update the TrialSite Network with updates. Sign up for the daily newsletter for updates.