PolarityBio Loosens I/E And Taps Many Provider Types To Reach More Patients

A conversation between PolarityBio Director, CSO, and COO Nikolai Sopko; PolarityBio Co-founder, President, and CMO Ned Swanson; and Clinical Leader Executive Editor Abby Proch

PolarityBio’s strategy for their Phase 3 trial design wasn’t the traditional go-to approach for many sponsor companies.

For one, they opted to widen their patient pool to include those who are sicker and for much longer. Secondly, they not only worked with the most well-known and expected academic medical centers. They spanned the U.S., tapping AMCs but also community centers and private practices.

In this interview, Director and CSO/COO Nikolai Sopko and President and CMO Ned Swanson discuss how the company intentionally opened the trial to a wider range of real-world patients — including those with wounds that had been present for an extremely long time (sometimes years old), prior infections, chronic Charcot foot, and even those with prior amputations — to ensure those with the greatest need had access to their advanced therapy. Equally critical was their close continuous collaboration with sites and their staff, who provided direct input on patient selection, logistics, and trial execution.

Discover how PolarityBio united rigorous science with practical insights from the field to yield rapid enrollment, deeper engagement from investigators, and a trial design (and data) that more accurately reflects the patients seen in everyday clinical practice.

Clinical Leader: PolarityBio enrolled 120 patients across the U.S. in 14 months for its SkinTE “living skin” trial for the treatment of diabetic foot ulcers (DFUs). This has reportedly outpaced historical enrollment timelines for DFU trials. What factors attributed to that quick enrollment?

Sopko: Looking at the trial design, there were a couple of strategic moves we made. One is focusing on Wagner 1 diabetic foot ulcers. We previously tried to go for a Wagner 2, but the Wagner 2 classification is broad, which makes your data more difficult to interpret, and it has a patient population that’s more difficult to enroll. So, we prematurely stopped that trial and moved our resources to the Wagner 1 patient population. But it's a relatively crowded space with these Wagner 1 patients; there's not a lot of trial sites in wound care. That gets into a challenge of how you get patients over other trials.

We really wanted the tough-to-treat Wagner 1 wounds that tend to have very low success for closure with just the standard of care. We focused on sicker Wagner 1 patients, who had wounds that were open for 300+ days, while a lot of other studies limited how old their wounds could be. We have no limit on the age of our wounds. We also had a very aggressive standard of care that, quite honestly, is often probably not being applied in standard practice because it's so resource intensive.

Our screen failure rate actually was 57%, so it wasn't necessarily low. Despite that, we still had fast enrollment and most of those screen failures were because when patients would get and respond to this rigorous standard of care, they no longer needed our product.

These criteria really helped capture these difficult-to-treat patients who represent those in real-life clinics and not the cherry-picked patients that would normally be put into a trial.

How do you make sure that you're capturing the right patient population? What made you decide that these, in fact, are the folks that need it the most?

Swanson: It was a whole host of factors. One is talking to KOLs before planning the trial design. Charcot foot and prior amputations are important predictors of developing DFUs and having complications from them. So, we did not exclude patients who've had those in the past. We also didn't exclude patients just because that specific ulcer has been infected and treated previously. A lot of our patients actually have had the same ulcer close and recur multiple times before coming into the study. To us, that's representing the patients who truly need an advanced therapy. And these were all things we gathered from the KOLs from the trial sites that we'd worked with previously, as advice going into the design.

And then, we opened up in an expanded access program. We're allowing even bigger wounds as well as patients that are on dialysis — and that's a big portion of patients who have DFUs in the real world. We're getting closer and closer to what people are really dealing with in their clinics every day.

Considering the competitive landscape, what do these prospective PIs and their sites say is a difference maker? Why would they work with you as opposed to another sponsor?

Sopko: Before we bring on a trial site, we have an extensive qualification process with a survey and on-site visit to make sure they have all the resources and infrastructure.  And then you motivate them to put their patients in the study by getting them excited about the technology while emphasizing that this is a real opportunity to help their patients. We spend a lot of time going over the product, the mechanism of action, and why it's unique and different. This is a new autologous cellular therapy that hasn't been seen in the space, and they get really excited by that.

Our product requires a little bit more labor than some of the other products. Since our incoming material is actually the patient's own skin, they have to take a small full thickness skin harvest. It’s a little bit more than just pulling something off the shelf. But PIs are humans, and they're going to gravitate to things that interest them, and potentially have a better outcome for their patients.

They also know that if they have a patient in the office and have a question, we're very responsive. We're regularly visiting and having monthly coordinator calls to share little tips and tricks. On those calls, they’re sharing issues and how people are getting around them.

Swanson: Also, we're getting site feedback and making adjustments in real time. Then, at the end of every trial, we get the full-blown feedback: What do we do well? What could we do better? What made a big difference? We’re actually making changes based on it. And sites that have been in multiple studies with us see those changes and improvements. They know their voices are being heard. For example, we provide continued support on how to take the harvest appropriately and apply the drug. And when the sites do their first harvest and first application, we are there on-site to answer questions immediately.

I understand the delivery model might be changing. How so, and what are the benefits?

Swanson: In our Phase 3 trial, we tried to get a broad representation of everywhere a patient might be — a lot of community-based private offices as well as academic and non-academic medical centers. And then specialties: podiatrists, dermatologists, vascular surgeons, and a whole variety of people that work on these patients in the real world. We think this product can be used anywhere by anyone. We certainly are going to start with surgically-focused providers, but eventually we think everybody can be trained to do this.

There are a lot of very complex reconstructive procedures that get done at big academic medical centers for other disease states, but for the 1.6 million patients with diabetic foot ulcers in the U.S., not all are treated at academic medical centers. We wanted this to be available to everybody in the office or wound clinic setting to have the trial reflect what’s happening in real life.

About The Experts:

Nikolai Sopko, MD, Ph.D., is a physician-scientist with a dedication to advancing regenerative medicine. As the chief operating officer and chief scientific officer at Polarity Bio, Inc. (formerly PolarityTE, Inc.), he continues to channel his passion for patient care and basic science research into developing regenerative therapeutics for complex diseases. He earned his MD from Case Western Reserve University and his Ph.D. in stem cell biology from the Cleveland Clinic. He then honed his surgical expertise at the Johns Hopkins James Buchanan Brady Urologic Institute as a physician scientist scholar. Dr. Sopko has authored over 70 peer-reviewed articles and book chapters, and is an NIH-sponsored researcher. He is also an award-winning, accomplished speaker on the subject of regenerative medicine.

Ned Swanson, MD, is the president & chief medical officer at PolarityBio, Inc. In this role, he drives the strategic vision and clinical development of innovative therapeutic solutions. Dr. Swanson's foundational contributions to the company began as a Co-founder and chief medical officer of PolarityTE from 2016 to 2021. He earned his MD from Harvard Medical School and holds a degree in bioengineering from the University of Pennsylvania. He refined his surgical skills during his residency in plastic surgery at Johns Hopkins. With his blend of entrepreneurial spirit, clinical acumen, and scientific rigor, Dr. Swanson continues to lead the charge in translating regenerative science into impactful patient care.