Texas Tech University Health Sciences Center Faculty Supporting Regeneron Trial

• By Meaghan Collier
• September 8, 2020

AMARILLO, TX- Texas Tech University Health Sciences Center (TTUHSC) faculty from Amarillo have engaged in a professional services agreement with PharmaTex Research, a multi-specialty clinical research group that conducts clinical trials required by the FDA, in a study of REGN-COV2, Regeneron’s novel anti-viral antibody cocktail that is being studied for its potential to treat people with COVID-19 and to prevent SARS-CoV-2 infection.

The first patient enrolled in this trial on August 22. Patients are getting this treatment via one-time infusion and are in inpatient and outpatient situations. Texas Tech Physicians (TTP) pulmonologist and critical care physician Mark Sigler, M.D. and TTP infectious disease specialist Tarek Naguib, M.D., MBA, are providing support and collaboration for the clinical trial. Additional team members from TTUHSC, Thomas Hale, Ph.D., and Afzal A. Siddiqui, M.D., Ph.D., helped to bring the trial to Amarillo. Currently in phase three, the trial is taking place at 150 sites internationally. Amarillo is the only city in West Texas with access. The study will end when three thousand patients have been enrolled worldwide.

“The goal of this trial is to assess the effectiveness of the Regeneron treatment in patients with COVID-19, “ Sigler said. “One of the important principles will be identifying patients that have been recently diagnosed and assess whether treatment soon after diagnosis is beneficial. Our hope is that this treatment may improve the likelihood of patients surviving COVID-19 if hospitalized or in the ICU, or decrease the likelihood of requiring hospitalization if it is administered as an outpatient.”

According to Regeneron, clinical trials of REGN-COV2 began in mid-June and the clinical program currently consists of three ongoing late-stage trials. The average number of patients per site is about 20; though Sigler would like to have more patients involved in the study in Amarillo. Half of the patients enrolled would get the drug and half would receive a placebo.

"This treatment appears to have significant promise for two reasons. First, this trial is evaluating a medication that has been enhanced to be very specific for the SARS-CoV-2 virus,” Sigler said. “Second, we know that for almost every other form of infection, whether bacterial or viral, treatment that is administered sooner appears to be more effective than treatment that is administered later in the course of the disease. This trial aims to identify patients that are relatively early in the disease course and assess whether earlier treatment is effective. If this trial demonstrates effectiveness of the medication, it would allow us to treat many patients earlier in the infectious stage than we have previously been able to."

Sigler said the promise of Regeneron comes from its work developing a successful treatment for Ebola in Africa. There, the therapy significantly improved mortality rates; the company has used the same technology that they used to make their Ebola treatment to make this COVID-19 treatment.

REGN-COV2 works when antibodies attach to the spike proteins of the coronavirus
The two antibodies prevent what researchers call viral escape—which can occur in treatments with only one antibody present. Sigler said the study is assessing side
effects of the drug; early results indicate, though, that the treatment is fairly safe. Additional testing of REGN-COV2 needs to take place to determine future protocol in fighting the virus.

“During a pandemic, we need to be scientific in quickly identifying potential therapies and then assessing their effectiveness,” Sigler said. “This is a wonderful example of
the local community coming together to find a solution to fight COVID-19 for the people of the Panhandle and beyond.”

PharmaTex is currently recruiting patients for the study. To be included, patients have to meet the following criteria:
• At least 18 years old
• Have laboratory-confirmed SARS-COV-2 infection
• Have COVID-19 symptoms like fever, dry cough, shortness of breath, sore throat, etc.
• Are currently not hospitalized or have not been previously hospitalized due to COVID-19

To learn more, call (806) 355-2581.