By Juanice Gray, email@example.com
Emily Moore contributed to this report
Natchitoches has become instrumental in the research to find an effective treatment for COVID-19. Barnum Medical Research, Inc. working in correlation with Biophytis enrolled the first US patient in the COVA trial at Natchitoches Regional Medical Center. Dr. Otis Barnum, DO, is the Principal Investigator for the first US site activated for this treatment only trial for COVID-19 in the US.
Biophytis, a France based company, contacted Barnum for possible inclusion in the trial for a treatment only medication called Sarconeos (BIO101). Biophytis flew a representative to Natchitoches to see if Barnum Medical Research were prepared to launch the first site in the US for the BIO101-CL05 study, and ultimately offered Barnum Medical Research the position within the trial. The trial was developed to study the potential of Sarconeos (BIO101) to prevent further deterioration in patients with COVID-19-related respiratory failure. The objective is to attempt to prevent them from being admitted into the intensive care unit (ICU) and requiring ventilation.
The research site in Natchitoches was the first site in the US to use the treatment drug and offer results. “It went well. We have had six patients in the study which is double blind and random, which means some patients are given the trial treatment, while others are given a placebo. There are specific criteria that must be met before the patient is asked to participate in the trial. If that criteria is met, the patient can then be enrolled.” Barnum said there are now eight sites in the US participating in the study along with numerous sites in Europe. The trial will continue until it reaches 300 patients, at which time Biophytis will apply with the FDA (Food and drug Administration) to put the drug in use for the purpose of COVID treatment or to continue the trial based on the data gathered thus far.
Dr. Warren Botnick is sub-investigator within the trial and a renowned pulmonologist who has been instrumental in supporting the success of this trial and site in Natchitoches. Barnum Medical Research director and lead trial coordinator Meg Barnum and Emily Moore, trial coordinator, under the supervision of Dr. Otis Barnum are responsible for collecting all patient data for entry and labs to be shipped to France for processing. Barnum said the drug has been used in Europe by athletes for performance enhancement as it improves muscle function by preserving strength, mobility and lung function.
Dr. Barnum said, “Finding an effective therapeutic agent to treat patients who become severely ill due to COVID-19 is vital is we going to reduce the mortality rate and hospitalization from this pandemic. The objective of this study is to investigate whether BIO101 can prevent further respiratory deterioration, reduce mortality rates and duration of hospitalization in these patients.”
Biophytis is a clinical stage biotechnology company specialized in the development of drug candidates for treatment of age-related diseases, including neuromuscular diseases. Biophytis holds an Investigational New Drug (IND) application from the FDA for COVA, a multinational Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the treatment of patients with COVID-19-related respiratory failure.