Diffusion Pharmaceuticals, Inc. (DFFN) stock prices were down by 3.33% as of the market closing on June 29th, 2021, bringing the price per share down to USD$0.7557 at the end of the trading day. Subsequent pre-market fluctuations saw the stock surge by 5.99%%, bringing it up to USD$0.801.
Phase 1 Trial
The company announced topline results from its Phase 1 trial of trans sodium crocetinate (TSC), its lead product candidate, on June 30th, 2021. Transcutaneous oxygen monitoring (TCOM) was used to measure the direct pharmacodynamic effects of TSC on peripheral tissue oxygenation in healthy normal volunteers enrolled for the trial. Topline results were founded on analyses of the primary endpoint data, indicating a positive dose-response trend in TCOM readings after TSC administration during the measurement period, as compared to a placebo.
Trial Results
Statistical significance was not reached in the magnitude of the treatment’s effect, largely because of the small number of healthy subjects in each cohort, as well as the inherent variability of tcp02 measurement. Despite this, primary endpoint data trends indicated improved peripheral oxygenation as compared to the placebo, with no evidence of hyperoxygenation. TSC was found to be safe and well-tolerated at all doses tested in the trial, with no major adverse events or dose-limiting toxicities.
Scope of TSC Data
The data collected served to further elucidate TSC’s exposure-response relationship, which the company will use to build on their clinical development strategy. Upcoming study designs for future trials will be informed by the collected data, as will the ongoing investigation of the timing of administration to maximize clinical efficacy. DFFN believes the data will complement findings from the company’s Covid-19 trial, as well as supporting the ongoing execution of its three well-controlled Oxygenation Trials.
Supporting TSC Trials
Each trial is uniquely designed to differentially explore TSC’s unique mechanism of action, with the individual and collective data from these studies forecasted to inform the company’s late phase programs and clinical indications in the push for the commercialization of TSC. The first of the trials was the TCOM Trial, with the primary endpoint evaluating the relative change in TCOM readings from baseline after TSC administration as compared to the placebo.
Future Outlook for DFFN
Armed with the recent results of their most recent clinical trial, DFFN is poised to capitalize on the opportunities afforded to it by the expanded scope of options made available to it. Investors are confident that the company will continue to ensure a continued trajectory of success by making use of the resources at their disposal and trial findings as they arise.
