No more placebos: Regeneron’s REGEN-COV “working well for patients”

Local News

AMARILLO, Texas (KAMR/KCIT) — After an Independent Data Monitoring Committee found Regeneron’s COVID-19 monoclonal antibody cocktail, REGEN-COV, to help reduce hospitalizations, the company announced Thursday it would no longer enroll placebo patients.

“Several months ago, the initial results were publicized and were very encouraging and just this past week, what’s called an Independent Data Monitoring Committee, which is a group of scientists that doesn’t really have any connection with us, or with Regeneron, reviewed all of the data on that trial and found it the trial should be stopped because Regeneron was working so well for patients that received it as an outpatient,” said Dr. Mark Sigler, a Texas Tech Physicians Pulmonologist & Critical Care Physician, and one of the researchers in Amarillo’s clinical trial.

Researchers at Texas Tech University Health Sciences Center in Amarillo have been working with Pharmatex Research, LLC. on the clinical trial since August 2020.

Moving forward, those who enroll in the trial will receive the antibody treatment. The ongoing clinical trials are phase three and will continue to enroll patients into 1,200 and 2,400 mg REGEN-COV treatment groups—good news for people who want to enroll in Amarillo.

“Now that the trial itself will no longer have a placebo arm, one of the questions that we’re still trying to answer is, what is the best dose of this antibody?” Dr. Sigler said.

TTUHSC said more than 150 people in the area have taken part in the trial so far, making Amarillo’s site one of the five participants in the U.S.

Dr. Sigler said he is grateful to be involved.

“When you think about going to medical school and becoming a doctor, you do it with the intention of of of helping patients and helping the people that live around you,” Dr. Sigler said. “So, when you develop a treatment that is effective for a condition that is killing or harming so many patients, it’s very gratifying to be active in helping those patients out.”

So far, the antibody treatment has been available to specific groups of people at-risk for coronavirus complications. Dr. Sigler sees a path forward for others now.

“What it means going forward, is that Regeneron will likely to apply to be available to a wider set of patients and hopefully, the antibody will be formally approved by the FDA for more widespread use,” Dr. Sigler added.

Dr. Sigler also said historically, it has taken years for similar clinical trials to be completed. He said much of the red tape has been removed to help coronavirus patients.

“There will likely still be a waiting period, exactly how long we don’t know. One of the reasons that is, is because the independent data monitoring committee that stopped the trial because of how positive the results were, while they have access to the data, Regeneron did not at the time of the review,” said Dr. Sigler “So, those those results are actually being made available to Regeneron. Then after that, the results would likely be made available to the FDA as well.”

REGEN-COV is authorized by the FDA for emergency use but is not FDA-approved. Requirements for who meets the criteria have not changed as of yet.

“I think it’s certainly important for patients that have a COVID infection to ask if they are candidates for receiving something like Regeneron,” said Dr. Sigler. “Because we do know that these antibody therapies are helpful when they are used as an outpatient.”

Dr. Sigler said the treatment and prevention of coronavirus happen on many different levels, but this step forward is one more reason to be optimistic.

“It’s important to be effective at all of those levels, and one of those levels is by vaccination by preventing infection. Another one of those levels is by having treatment for those that develop an infection, and both of them are very important,” Dr. Sigler said. “I mean, I’m hopeful that as we continue to improve our treatments for patients that have infections, in addition to the success that the vaccinations have had, that it will mean that our patients that develop coronavirus infections continue to do better overall.”

According to Regeneron, independent researchers showed the treatment effectively neutralizes emerging strains of the virus as well.

Dr. Sigler said because of the success of the Regeneron trial, the National Institutes of Health have reached out to TTUHSC about participating in future clinical trials. He said those should begin in the next few months.

More from

Copyright 2021 Nexstar Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

Video Forecast

More Forecast

Don't Miss