Diffusion Pharmaceuticals Inc (NASDAQ: DFFN) is an biopharmaceutical company which keeps on working on new therapies, announced results of the company’s phase I trial of its lead product candidate, trans sodium crocetinate (“TSC”), that helps in enhancing the ability to circulate oxygen to those critical areas of the body where it is required most.
TSC – no evidence of hyperoxygenation
In the trial phase, transcutaneous oxygen monitoring was used to calculate the direct (pharmacodynamics) impact of trans sodium crocetinate (TSC) in healthy volunteers on various peripheral oxygenation tissue. Based on the results, a positive response trend persisted throughout the trial phase. In addition, the initial trends showed a positive results in peripheral oxygenation when compared with placebo, with no evidence of hyperoxygenation, and was safe with no severe side effects.
The results further strengthen the company’s trial and worked on novel therapy development strategy (a step forward). The management also believes TCOM data matches with the data obtained during their trial for COVID-19 and also backed the undergoing execution of company’s three phase – Oxygenation Trials. In addition, the results of all the trials is uniquely designed to investigate TSC’s novel mechanism of action differentially.
First of three Oxygenation Trials
Diffusion Pharmaceuticals plans to conduct the trials in 2021, and the design for the same is as follows –
TCOM Trial- In comparison to placebo, the trial evaluated the comparative difference in reading from the baseline post TSC administration.
Altitude Trial (induced hypoxia) – Altitude trial is expected to evaluate impact of Trans sodium crocetinate on higher oxygen usage, or VO2 and will also monitor if there is any pressure of blood oxygen
DLCO Trial – DLCO trial evaluates the working of Trans sodium crocetinate on the circulation of carbon monoxide (CO) via lungs in patients who are earlier diagnosed for lung disease and has an unusual baseline test result. The study is expected to monitor the diversion in the influence of TSC on development in DLCO and total km covered within a six-minute by walking.
Diffusion Pharmaceuticals expects beginning and successfully completing the Altitude Trials and DLCO during July-December 2021.