On November 22, 2021 Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) ("Diffusion" or the "Company"), a biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most, reported it has dosed the first participants in its Altitude Trial (Press release, Diffusion Pharmaceuticals, NOV 22, 2021, View Source [SID1234595893]). The trial will evaluate the Company’s lead product candidate, trans sodium crocetinate ("TSC"), in normal healthy volunteers subjected to incremental levels of physical exertion while exposed to hypoxic and hypobaric conditions, or "simulated altitude."
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"It’s been exciting working with our internationally recognized partners to get this trial started, and we look forward to continuing to leverage their expertise in hypoxia research and their unique extreme exposure simulation facilities as the study proceeds," said Chris Galloway, M.D., Chief Medical Officer of Diffusion. "We designed the Altitude Trial not only to evaluate how TSC can enhance oxygen uptake in a simulated hypoxic environment while under stress, but also to evaluate how effectively oxygen is delivered and ultimately utilized under these conditions. We believe the Altitude Trial’s results can inform additional clinical uses of TSC to enhance oxygenation across a multitude of diseases complicated by hypoxia."
The Altitude Trial is a double-blind, randomized, placebo-controlled crossover study designed to evaluate the effects of TSC on maximal oxygen consumption, or VO2, and partial pressure of blood oxygen, or PaO2, in normal healthy volunteers subjected to incremental levels of physical exertion while exposed to "simulated altitude." Diffusion intends to enroll 30 healthy volunteers and give each volunteer a single dose of TSC at one of three different doses. This study will evaluate the effectiveness of TSC in enhancing oxygen delivery to the blood and tissues during exercise under hypoxic conditions. The Company anticipates completing the study in late December 2021 or early January 2022, subject to the pace of participant enrollment, and reporting topline results within two months of study completion.
The Altitude Trial is the second in a series of three, short-term studies Diffusion is conducting intended to provide the Company with additional information regarding TSC’s mechanism of action and dose-response characteristics. The results of the Altitude Trial, together with the results of the Company’s TCOM Trial (announced in June 2021) and its ILD-DLCO Trial, expected to commence in December 2021, will be used to further inform the design of clinical trials aimed at supporting the commercialization of TSC as a treatment for conditions complicated by hypoxia.
While the Company intends to continue developing data to support TSC’s broad potential uses, it recently announced that its near-term focus will be the design and execution of a clinical program to support the use of intravenously administered TSC as a treatment for hypoxic solid tumors, and that it intends to obtain input from the U.S. Food and Drug Administration on the program’s design in early 2022.