In the third Trial Trailblazers podcast, initially hosted on BioPharma Dive, Nicole Latimer, CEO of Medrio, is joined by Mike Rosenbluth, Founder and CEO of Swing Therapeutics.
They discuss the behind-the-scenes process of developing a digital therapeutic to receive FDA De Novo marketing authorization—from selecting a disease focus area to commercialization.
In this conversation, Nicole and Mike covered a range of topics, including:
- Founding Swing Therapeutics to make a difference
- Addressing unmet patient needs with technology
- Taking inspiration from other DTx companies
- Deciding to develop a prescription therapeutic versus a commercial product
- Navigating study design challenges
- Determining a decentralized approach
- Understanding FDA criteria for decentralization and virtual sites
- Working with FDA regulators
- Focusing on reimbursement and commercialization from the beginning
- Collaborating with others to get further faster
- Securing funding amidst a difficult economic climate
- Collecting data while raising rounds
Note: Not all questions are included below. Responses have been edited for conciseness. We’ve included time stamps so you can check out the recorded audio to hear more.
Tell me about why you founded Swing Therapeutics?
[2:56]
During my time in venture investing, it blew my mind how digital health companies could use software tools to treat patients at scale. In many diseases, there is a real gap in care that could be impacted by software.
I also recognized that some of the key challenges in this field are around reimbursement and business models. I felt that some of the learnings from the previous decades around genomics and establishing the right business model and pricing to enable patient impact were applicable to what was happening in digital therapeutics.
Can you describe how Stanza works?
[4:24]
Stanza is an FDA-cleared digital behavioral therapy for the treatment of fibromyalgia symptoms. It is a smartphone-based application that delivers a type of behavioral therapy called acceptance and commitment therapy (ACT). The core part of the program is about 42 sessions. It takes about 12 weeks, followed by a reinforcement period that can be used over the longer term to reinforce all the lessons and benefits.
If you look at the guidelines for fibromyalgia, they really recommend a multimodal approach of drugs, exercise, and cognitive behavioral therapy. What we saw is really the challenge, or the gap in care, was that no one was getting access to behavioral therapy.
It takes a trained pain psychologist. Naturally, there’s not a huge population of trained pain psychologists that can deliver this [behavioral therapy] for the 10 million people in the US with fibromyalgia. And so if we could effectively translate what an expert pain psychologist does into an application that could be delivered in a self-guided way, we could really expand access to all those patients who needed it.
Did you take inspiration from other prescription digital therapeutics?
[6:47]
We had the opportunity to really learn and take advantage of some of the early developments in this field. I’d say what gave us confidence that we could deliver an effective product here was a few-fold.
One is just the wealth of evidence that’s out there for fibromyalgia that cognitive behavioral therapy and acceptance and commitment therapy are effective. There are a lot of studies out there that all showed, in general, that this was a positive, clinically effective approach. That was one data point that we had to say, “Okay, we know that this general approach is effective.”
We also saw other companies or research labs that were able to effectively translate behavioral therapies into software. Research that Pear Therapeutics built on, or Akili, or research labs across the US and Europe. We knew that you could translate these programs into software and that they could be effective.
Could you share about the decision to develop a prescription digital therapeutic?
[8:30]
My belief was that if we could closely mimic what other interventions have done with behavioral therapy, that would be the most likely way to get broad adoption across the ecosystem.
The real limitation in terms of adoption was that most of these interventions were not scalable. Most interventions were certainly not set up in a way that every physician could access, and therefore, would not get integrated into a standard of care. You can integrate an intervention into a standard of care by making it fit into the current healthcare system. One way to do that is through a digital therapeutic.
What are the challenges you faced in designing and running clinical trials?
[10:01]
We applied to the FDA to get breakthrough device designation, which is intended for novel treatments in high-need clinical areas. This designation enabled us to have some fairly quick turnarounds with the FDA in terms of asking questions and getting answers to help our clinical study design.
But there were still a lot of unknowns. If you looked at the literature around most treatments in this ecosystem, they were always compared to a waitlist control, their comparator, or treatment as usual. However, the FDA felt that we needed to really compare to a sham or something else.
That was one of the things that we were really trying to figure out. What comparator could work? It’s easy to say, “Let’s just create a sham.” But, how do you actually design something that, for 12 weeks, would, in essence, trick a patient into thinking they’re getting behavioral therapy? And is that an ethically appropriate thing to do?
And so we chose instead to develop an active control. We know that these patients track symptoms. There are symptom-tracking applications that could be used as part of a standard of care. So we developed a symptom tracker, which enabled patients to input symptoms on a daily basis, monitor them over time, and also have access to fibromyalgia education.
We tested that approach in a pilot study, because we had no idea what the effect would be. Then we replicated that when we saw some good indications that this was a viable control in our pivotal study.
Tell us about your decentralized approach.
[15:37]
You’re getting a much broader catchment of patients—many who have not participated in clinical trials before. That really got us to a patient population that’s more consistent with who’s going to use this in the real world.
When we thought about every step of the process, those initial patient visits, we realized that everything could be done remotely. Fibromyalgia can be diagnosed with a patient survey that can be done remotely. We did require lab testing, but that could be done at a local lab.
So when we really looked at it, and also talked with the FDA about the acceptability of this, this seemed to be a really good type of trial where a decentralized approach would be effective.
Was the FDA looking for specific criteria for a decentralized or virtual site approach?
[17:14]
They were. A lot of it was around making sure that the person who is in the trial is the right person. So it was a lot around identity verification and what our processes were with that.
The guidance the FDA gave us led us to believe that we could effectively do this. But it did make us think through the identity verification processes at the beginning of every visit.
What lessons did you learn from working with regulators?
[19:42]
This is the first time that I have been in a company developing an FDA-regulated product. You hear a lot of opinions about how much to interface with the FDA. Everyone I talked to would give me a very different answer on that.
We were doing so many different and potentially novel things that it was helpful to get feedback, and it also reduced our overall risk. Having that breakthrough designation enabled us to have a tight enough turnaround time in order to get answers that could guide our decision-making.
How did you move from FDA clearance to market launch, including reimbursement and commercialization?
[21:49]
When you’re developing any sort of novel technology or medical device, regulatory clearance is really the first step in terms of how you build a company and get this adopted. So we have built our strategy for the long game.
We’ve built our strategy around developing very rigorous clinical evidence. We’ve run two randomized controlled trials. Our most recent randomized controlled trial was published in The Lancet. So it was the first digital therapeutic and the first novel treatment for fibromyalgia that has ever been published. There, we have long-term data and that helps with reimbursement.
But we realized we could not wait the five to seven years it might take to get broad coverage. We’d seen the challenges that some of the first prescription digital therapeutics companies had.
Additionally, during the development of Stanza, we came to know this patient population well. We recognized that having a novel treatment was only one part of the solution. There’s a huge gap in care for these patients. And so as we thought, “What if we could be a patient champion? What if we could help create a new specialty for these patients?” And because of that, we started Swing Care, which is our virtual care clinic for the comprehensive treatment of fibromyalgia.
Swing Care helped solve a few problems. One was the huge clinical need in this patient population for a team of specialists who really understand fibromyalgia. The other was that it enabled Swing to have an alternative path around reimbursement. A path that wasn’t reliant on getting brand new coverage through pharmacy benefits or creating a new Medicare benefits category.
By helping to set up a virtual clinic, we could leverage new codes and reimbursement paths that were being established for products like this. Meanwhile, we work for broader coverage of the category itself.
How much collaboration is happening in this category? Are there joint efforts to advance it?”
[27:45]
There are a couple of different areas of collaboration. There is the American Telemedicine Association and the Digital Therapeutic Alliance. They have merged those organizations from an awareness and a lobbying exercise. And that is a great organization that’s helping to push things forward.
Big Health also just recently received FDA clearance on two of their products in the last year. They have really been advocating for new codes to get on the new Medicare Fee Schedule for digital therapeutics reimbursement.
We’re actually collaborating with Big Health and we’re starting to prescribe their product, Sleepio, within our own Swing Care practice. Insomnia is an issue that impacts virtually all of our patients, so having another tool in the toolbox for our patients is tremendously helpful.
How do you sustain funding? What advice would you give to founders in today’s environment?
[28:54]
We could probably have a whole podcast about this. Some of it is about finding the right investor partners who will be good partners to you and have the same vision. Initially, find those investors who have invested in companies similar to yours.
We’ve been able to build a high amount of trust with our investors over time. I take the approach of being entirely transparent about what’s working well and what’s not. Building that relationship so that investors have a high amount of trust in what you say and what you do is really important to have that continued support over time.
To what extent was data important in your funding?
[31:11]
I’d say, in general, for any healthcare technology company, data is important. It’s what this field is built on. Regulatory clearance is built on data. Reimbursement is generally built on data.
Our first round of financing was built on not our data, but on data in the field. We built enough conviction based on that data that the risks that we were taking were worthwhile and low enough to move forward.
Our next round of financing was based on the data that we developed in our pilot study. Using that data to say, “This works, right? We just need to reproduce this on a broader scale.” And so we reduced the product risk and we reduced the clinical risk. That was certainly critical to enable us to move forward.
Now, the data is a little bit different. It’s not the clinical data, but it’s the commercial data. We’re in a situation where it’s really a “show me” point. We are growing the company and gathering investment based on the commercial data that we’re generating.
Where can people find you?
[35:27]
You can visit Swing Therapeutics. You can also visit Swing Care, which is our virtual care provider.
Want more resources on running clinical trials? Read our eBook, “How to Run a Nimble, Cost-Effective Trial.”