FDA Accepts COVID-19 Clinical Study and Advises on Next Steps for Pre-IND Filing by Medolife Rx - Seite 2

While both the palliative and therapeutic potential of Escozine were highlighted in the filing, the FDA recognized the potential therapeutic benefits of the drug, alluding to its ability to fight the COVID-19 virus, another important aspect of the response.

“Another interesting aspect of this Pre-IND filing is that we included both the therapeutic and palliative potential of Escozine in treating COVID-19,” noted Medolife advisory board member and clinical adviser Dr. Annabelle Morgan. “This means that the drug could help reduce symptoms in patients who have the virus in addition to its potential benefit in fighting the virus itself. I am optimistic that the response seemed to point to its potential therapeutic benefit as well as its palliative.”

Lead researcher on the Escozine clinical trial program, Dr. Khalid Matalka, stated: “I am very pleased that the FDA acknowledged the results of our clinical trial on Escozine as a COVID-19 therapeutic in the DR. It was an extremely positive outcome, where we saw that after four to five days of taking Escozine as a monotherapy, all COVID-19 positive clinical participants had a significant improvement and tested negative for the virus within a week time. The drug contains four small molecular peptides that block ion channels causing a multi-action effect on the SARS-CoV-2 pathogenesis as both a therapeutic and palliative potential drug.”

“It is understandable that the FDA is paying close attention to the toxicological aspects of new drug applications, because excessive studies from vaccinations caused the FDA to be more cautious about the side-effects of the drugs, especially how they affect the body on a genetic level,” added Dr. Mikaelian. “Fortunately, these additional studies will not add more time to our program than originally anticipated.”

Also included in the response was a very detailed roadmap for the next phases of U.S. clinical trials with specific protocols. The amount of detail given in the guidelines will dramatically expedite the Company’s timeline for preparing for the next steps of the clinical program.

“The FDA regularly provides the level of detail provided in our response to companies who have already passed the Pre-IND stage. We believe this is an indication of the level of confidence the FDA has in Escozine’s potential for approval and will allow for more time in the market approval process,” stated Dr. Mikaelian.

Christina DiArcangelo added: “The FDA has provided us with clinically meaningful endpoints and assistance in the design of future trials, including minor diversity and pediatric patients. By doing so, we have a clear understanding as to how to proceed forward, not only with our next study but with the development of the entire Escozine clinical program. This information is so valuable and will help us to expedite our program in a meaningful way. We are very grateful for the FDA’s thorough guidance.”