Diffusion Pharmaceuticals Inc (NASDAQ:DFFN) recently announced that it submitted an Investigational New Drug (IND) application filing to the Food and Drug Administration for trans sodium crocetinate (TSC).
The IND filing took into account the FDA’s pre-IND guidelines. The filing also describes plans to carry out a Phase 1b/2b clinical development trial, which will evaluate TSC in COVID-19 patients. The clinical program will target 424 coronavirus patients that have low oxygen levels and weakened respiratory function. Diffusion aims to evaluate the use of Diffusion as a viable treatment for COVID-19 patients by exploiting its oxygen-enhancing mechanism.
COVID-19 patients usually fail to breathe properly due to low oxygen due to damaged lungs. A treatment option that can address the low oxygen problem would provide significant relief to patients. The IND also revealed that the clinical trial program will feature an open-label Phase 1b lead-in clinical trial. Upon its success, it will be a precursor for two double-blind, randomized phase 2b trials.
The lead-in trial will evaluate COVID-19 patients that have been hospitalized at the Romanian National Institute of Infectious Diseases (NIID). Dosing of the patients in the clinical trial should commence before the end of July as per the guidelines provided by the National Agency for Medicines and Medical Devices (NAMMD). The trial will evaluate the treatment’s safety, and also whether patients experience higher oxygenation levels.
“We believe that filing our international clinical development plan as part of the IND is our best path to advance TSC as a new treatment to help boost low oxygen levels and alter the downward spiral in COVID-19,” stated Diffusion’s CEO, David Kalergis.
The CEO also noted that the first dosing in patients started in July and that the initial data updates should be out before the end of Q3 2020. The company plans to kick off a Phase 2b clinical trials if the data from the phase 1b will be favorable, and once regulatory approval is granted. Phase 2b trials are expected to kick off in Q1, and it will be conducted in Romania, and the U.S. Roughly 200 patients are expected to sign up in each of the two phase 2b trials.