Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) (“Diffusion” or the “Company”), an innovative biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most, today announced topline results from the Company’s Phase 1 trial of its lead product candidate, trans sodium crocetinate (“TSC”).
In this trial, transcutaneous oxygen monitoring (“TCOM”) was used to measure the direct pharmacodynamic effects of TSC on peripheral tissue oxygenation in healthy normal volunteers. Topline results were based upon analyses of primary endpoint data, which indicate, as compared to placebo, a positive dose-response trend in TCOM readings after TSC administration that persisted through the measurement period. Due in part to the small number of healthy subjects in each cohort, and the inherent variability of tcpO2 measurement, the magnitude of effect was not statistically significant; however, the trends in the primary endpoint data indicated an improvement in peripheral oxygenation compared to placebo, with no evidence of hyperoxygenation. Furthermore, TSC was safe and well-tolerated at all doses tested with no serious adverse events or dose-limiting toxicities.
“The positive trend observed in the TCOM trial is very encouraging,” said Chris Galloway, M.D., Diffusion’s Chief Medical Officer. “We believe the data further clarify TSC’s exposure-response relationship and successfully build on our clinical development strategy. These data will inform study design for upcoming trials and our ongoing investigation of the timing of administration to maximize clinical efficacy. We also believe the TCOM data complement recent data obtained from our COVID-19 trial and further support our ongoing execution of our three well-controlled Oxygenation Trials, where each study is uniquely designed to differentially investigate TSC’s novel mechanism of action. We expect the individual and collective data from these studies will inform our late phase programs and clinical indications to pursue for commercialization of TSC.”
