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FDA clearance of trans sodium crocetinate allows Diffusion to proceed with their latest Phase II oxygenation trial.
Diffusion Pharmaceuticals, a biopharmaceutical company developing novel oxygenation therapies, announced on Aug. 30, 2021 that they had obtained investigational new drug (IND) clearance from FDA’s Pulmonology, Allergy, and Critical Care division on their lead product candidate, trans sodium crocetinate (TSC).
Diffusion now has four open INDs related to TSC among select FDA divisions. In addition to the new clearance, there are existing ones from the Cardiology and Nephrology, Neurology, and Oncology divisions.
The trial that will be conducted under the new IND will be a Phase II, double-blind, randomized, placebo-controlled study that will evaluate the effects of TSC on the diffusion of carbon monoxide through the lungs (DLCO) in patients with Interstitial Lung Disease (ILD).
The ILD-DLCO trial will be the third of Diffusion’s three oxygenation trials, which were designed to assess the ability of TSC to enhance oxygen uptake, peripheral oxygenation, and consumption. Their results will inform the selection of TSC’s dosing regimen and initial lead indication, which Diffusion expects will be selected by the end of 2021 and initiated in the first half of 2022, according to a company press release.
“The clearance of our new IND within the Pulmonary Division is a great milestone for Diffusion and TSC,” said Chris Galloway, chief medical officer of Diffusion, in the press release. “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.”