Diffusion’s Chief Medical Officer Dr. Chris Galloway provides an overview of the ILD-DLCO Trial, the third in a trio of Oxygenation Trials that will inform late-phase programs and clinical indications for lead drug candidate TSC.
Lauren Ashburn: Welcome to Fueling Life, a podcast brought to you by, and all about, Diffusion Pharmaceuticals, an innovative biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen where it is needed most. I’m your host Lauren Ashburn.
Today, I’m speaking with Dr. Chris Galloway, the Chief Medical Officer of Diffusion Pharmaceuticals. An executive physician with diverse clinical and pharmaceutical industry experience, Dr. Galloway joined Diffusion Pharmaceuticals in October of 2020. He oversees the development strategy for Trans sodium crocetinate, or TSC, the company’s lead product being developed to enhance the diffusion of oxygen to hypoxic body tissue — that is, tissue with low oxygen levels. This is a serious complication of many intractable and difficult-to-treat medical conditions.
We’ve been speaking with Dr. Galloway about three foundational short term clinical studies of TSC. Collectively, they are known as the Oxygenation Trials and they use experimental models to evaluate dose response and the effects of TSC on oxygenation through several different lenses. In this podcast, we’re focusing on the third and final Oxygenation Trial, known as the ILD-DLCO Trial, and what comes next.
Welcome back to the podcast, Chris.
Dr. Chris Galloway: Thanks for having me, Lauren.
Lauren Ashburn: Chris, let’s start by unpacking the acronyms in the trial name. Tell us about ILD and DLCO. What do they stand for?
Dr. Chris Galloway: Well, ILD stands for interstitial lung disease, and interstitial lung disease is a group of pulmonary diseases that cause progressive scarring of the lungs. They can be caused by a multitude of insults, such as hazardous materials, medication such as chemo or radiation, sometimes autoimmune diseases and sometimes just unknown. And DLCO stands for diffusing capacity of the lungs for carbon monoxide, and is often one of the earliest tests to diagnose interstitial lung disease and also follow its progression or its response to treatment.
Lauren Ashburn: I recall from our earlier interviews that the first two Oxygenation Trials, the TCOM and the Altitude studies, focused on healthy volunteers. Why is it important to center this study on patients with interstitial lung disease?
Dr. Chris Galloway: Well, each of our Oxygenation Trials has a different focus on the oxygen journey — from uptake in the lungs, delivery in the circulatory system, to end-organ distribution. TCOM we’ve completed. That satisfies as end-organ tissue delivery and we’ve also learned more about dose. Altitude is soon to be started up. We’ll learn more there. The ILD-DLCO Trial is that progression naturally of clinical development, where we learn along the way and we’re going to be focused on the improvement in oxygen uptake in the lungs. ILD patients have an inherent diffusion defect or an oxygen transfer defect and that’s measured by the DLCO tests. What we hope to see is that after administration of TSC, they have an improvement in this DLCO test or the transfer efficiency of carbon monoxide of the test, which is then a surrogate for how well we can enhance, or TSC can enhance, oxygen transfer.
Lauren Ashburn: In addition to interstitial lung disease, is the ILD-DLCO trial relevant to any other diseases or medical conditions?
Dr. Chris Galloway: We absolutely believe so. TSC is truly agnostic, meaning it’s not a biomarker or catalyzed by a certain receptor. So anywhere where TSC can enhance that transfer efficiency… In this study, we hope we can see this in the interstitial lung disease patients. But if we can improve that oxygen transfer efficiency there, it would naturally translate into almost any pulmonary condition where oxygen transfer efficiency is a problem, whether that’s an acute infectious issue, inflammatory issue, [or] a traumatic issue. So “yes” is the answer. It potentially translates into a multitude of pulmonary conditions.
Lauren Ashburn: When do you expect to initiate this trial? And when will Diffusion be reporting results?
Dr. Chris Galloway: Our planning for the ILD-DLCO Trial has been ongoing for months. These patients are very complicated and often these patients are seen at tertiary referral or academic centers. We’ve been in discussions with academic centers for months now and we’re getting closer with start up procedures to then have [the] first patient enrolled in quarter four of this year and then hope to have top-line data readout one to two months after that last patient is enrolled.
Lauren Ashburn: Once you’ve completed this trial, you will have completed all three of the Oxygenation Trials. What’s the next step in the development plan for TSC?
Dr. Chris Galloway: Well, our development plan is ongoing in parallel with each of these trials. Each of these trials are unique and differentiated from one another, not only helping to clarify [the] mechanism of action but also our dosing regimen. Each trial along the way informs our indications we seek to go into and that later-phase trial planning along with the regulatory pathway and what indications we will be seeking approval based on and then commercialization. Clinical development is ongoing and each of these trials informs a multitude of indications that Diffusion is planning to seek approval for TSC in.
Lauren Ashburn: This has been so informative. Thank you so much. It’s been a pleasure talking with you and I look forward to our next chat.
Dr. Chris Galloway: Thanks for your time, Lauren.
Lauren Ashburn: Thanks for listening. Fueling Life is a podcast from Diffusion Pharmaceuticals. Stay tuned for our next episodes and follow us on Spotify or wherever you get your podcasts.