- The stock price of Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) increased by over 7% pre-market. This is why it happened.
The stock price of Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) – an innovative biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most – increased by over 7% pre-market. Investors are responding positively to Diffusion Pharmaceuticals announcing that the company has obtained clearance of its Investigational New Drug (IND) application submitted to the U.S. Food and Drug Administration’s (FDA) Pulmonology, Allergy, and Critical Care Division for the company’s lead product candidate trans sodium crocetinate (TSC).
Diffusion now has open INDs related to TSC with 4 FDA divisions– Pulmonology, Allergy, and Critical Care; Cardiology and Nephrology; Neurology; and Oncology – which they believe further supports TSC’s broad therapeutic potential. And the previously announced trial to be conducted under the most recent IND will be a Phase 2, double-blind, randomized, placebo-controlled study, which will evaluate the effects of TSC in patients with Interstitial Lung Disease (ILD) on the diffusion of carbon monoxide through the lungs (or DLCO) as well as functional change in the patient’s 6-minute walk test.
The ILD-DLCO trial will be the third of Diffusion’s three Oxygenation Trials. And these Oxygenation Trials were designed to further clarify both dose and duration of clinical effect to assess the ability of TSC to enhance oxygen uptake, peripheral oxygenation, and consumption. The results of the Oxygenation Trials will inform the selection of TSC’s dosing regimen and initial lead indication, which will be selected and communicated by year-end 2021 with a resulting clinical study expected to be initiated in the first half of 2022.
“The clearance of our new IND within the Pulmonary Division is a great milestone for Diffusion and TSC. Not only does it give us the ability to conduct the ILD-DLCO trial in the U.S., but also expands our potential regulatory opportunities across multiple divisions at the FDA encompassing numerous therapeutic areas. In parallel, we are actively engaged with our partners preparing for study start up with the expectation to dose the first ILD patients in this Phase 2 ILD-DLCO Trial during the fourth quarter of this year. We believe clearance of this fourth IND by the FDA speaks to the broad applicability of TSC across a myriad of indications that are complicated by hypoxia where TSC could be a part of multi-modal therapy with the goal of improving patient outcomes.”
— Chris Galloway, M.D., CMO of Diffusion
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