Diffusion Pharmaceuticals Announces Clearance of IND Application for TSC by FDA’s Pulmonology, Allergy & Critical Care Division
Diffusion Pharmaceuticals Inc. recently announced it has obtained clearance of its Investigational New Drug (IND) application submitted to the US 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 four FDA divisions– Pulmonology, Allergy, and Critical Care; Cardiology and Nephrology; Neurology; and Oncology — which the company believes further supports TSC’s broad therapeutic potential.
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. 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 these 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.
Chris Galloway, MD, CMO of Diffusion, said “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 US, 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.”
Diffusion Pharmaceuticals Inc. is an innovative biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most. Diffusion’s lead product candidate, TSC, is being developed to enhance the diffusion of oxygen to tissues with low oxygen levels, also known as hypoxia, a serious complication of many of medicine’s most intractable and difficult-to-treat conditions. In addition to TSC, Diffusion’s product candidate DFN-529, a novel, allosteric PI3K/Akt/mTOR Pathway inhibitor, is in early-stage development. For more information, www.diffusionpharma.com.
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